{"text_format":"1","workbook":"xlsx","n_sheets":13,"sheets":["Home","1.Guidance","2.Safety","3.Staff","4.Facility","5.Device","6.QAQM","7.Participant","8.Pharmacy","9.Lab","10.CTRA","Summary","SITE TYPE (HIDE ME!)"],"not_rendered":{"charts":0,"images":6,"macros":1,"external_links":1,"defined_names":37,"comments":10,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"Home","index":0,"n_rows":19,"n_cols":1,"rows_kept":19,"cut":false,"hidden":false,"merged":[[0,0,6,16],[12,0,12,16],[13,0,13,16],[14,0,14,16],[15,0,15,16],[10,0,10,15],[23,0,23,16],[7,0,7,16],[8,0,8,16],[9,0,9,16],[16,0,16,16],[17,0,17,16],[18,0,18,16],[19,0,19,16],[20,0,20,16],[22,0,22,16]]}
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["\nThis checklist and toolkit provides a summary of recommendations, considerations and resources for clinical research sites in the conduct of clinical trials, particularly those sites conducting early phase studies.  For existing clinical trial sites it will validate your current practices, for new sites it will guide you in your set up.\n"]
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["Clicking on an icon below will lead you to that respective section of the best practice checklist for the conduct of clinical trials.  Work through the relevant section (tabs) of the checklist in your preferred order, filtering by either IP (Investigational Product) or DEVICE.\nYou can also filter on the SUMMARY page to show only your NO responses, to see what areas your site needs to focus on to meet best practice standards."]
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["We would welcome your feedback on this tool.  Please email any comments to info@ctiq.com.au"]

{"sheet":"1.Guidance","index":1,"n_rows":30,"n_cols":13,"rows_kept":30,"cut":false,"hidden":false,"merged":[[28,0,29,0],[20,2,29,2],[28,3,29,3],[28,6,29,6],[28,10,29,10],[28,9,29,9],[28,12,29,12],[28,11,29,11],[26,0,27,0],[26,3,27,3],[26,5,27,5],[24,0,25,0],[24,3,25,3],[24,5,25,5],[20,3,21,3],[20,5,21,5],[20,11,21,11],[28,5,29,5],[22,5,23,5],[22,0,23,0],[3,12,4,12],[6,12,7,12],[3,11,4,11],[3,13,4,13],[26,6,27,6],[26,9,27,9],[26,11,27,11],[10,6,11,6],[10,9,11,9],[10,11,11,11],[10,12,11,12],[10,13,11,13],[8,6,9,6],[8,9,9,9],[8,10,9,10],[8,11,9,11],[8,12,9,12],[26,10,27,10],[22,13,23,13],[24,10,25,10],[22,11,23,11],[22,9,23,9],[22,12,23,12],[22,6,23,6],[16,11,17,11],[16,12,17,12],[22,10,23,10],[22,3,23,3],[18,0,19,0],[18,3,19,3],[16,2,19,2],[16,3,17,3],[16,5,17,5],[18,5,19,5],[20,0,21,0],[16,13,17,13],[14,12,15,12],[14,13,15,13],[14,10,15,10],[26,12,27,12],[26,13,27,13],[18,6,19,6],[18,9,19,9],[18,11,19,11],[18,12,19,12],[18,13,19,13],[20,12,21,12],[20,13,21,13],[18,10,19,10],[24,6,25,6],[24,9,25,9],[24,11,25,11],[24,12,25,12],[20,10,21,10],[20,6,21,6],[20,9,21,9],[24,13,25,13],[16,10,17,10],[16,9,17,9],[6,13,7,13],[8,0,9,0],[8,3,9,3],[8,5,9,5],[8,13,9,13],[6,3,7,3],[6,5,7,5],[6,6,7,6],[6,11,7,11],[8,2,15,2],[3,2,7,2],[12,10,13,10],[12,11,13,11],[12,12,13,12],[10,0,11,0],[10,10,11,10],[10,3,11,3],[10,5,11,5],[14,0,15,0],[14,11,15,11],[12,13,13,13],[12,9,13,9],[12,3,13,3],[12,5,13,5],[6,9,7,9],[12,0,13,0],[3,0,4,0],[16,0,17,0],[0,9,1,9],[0,0,1,8],[3,10,4,10],[3,3,4,3],[3,4,4,4],[3,5,4,5],[3,8,4,8],[6,0,7,0],[6,10,7,10],[3,9,4,9],[14,3,15,3],[14,5,15,5],[14,6,15,6],[14,9,15,9],[12,8,13,8],[12,4,13,4]]}
["Research Guidance Documents",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If Other","If No"]
[1.01,"IP","Does your site have access to and review the following documents","\nICH guidelines for Good Clinical Practice (ICH-GCP and TGA annotation)?","INPUT","The Guidance on Good Clinical Practice (GCP) are internationally accepted standards for the conduct of a clinical trial; compliance with the Guidance is a standard condition of ethical approval. Site staff should hold current GCP certification and have a sound knowledge of these principles.\n",{"$f":"HYPERLINK(\"https://www.tga.gov.au/publication/note-guidance-good-clinical-practice\",\"ICH-GCP Guidelines\")","v":"ICH-GCP Guidelines"},"https://www.tga.gov.au/publication/note-guidance-good-clinical-practice\n",{"$f":"IF($E4=\"No\",$M4,$L4)","v":0},null,"Any Phase",null,"GCP compliance is a requirement for applicable clinical trials ethically approved by a Human Research Ethics Committee (HREC). "]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf\",\"Integrated Addendum to ICH E6(R1): Guideline for GCP\")","v":"Integrated Addendum to ICH E6(R1): Guideline for GCP"},"http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf"]
[{"$f":"A4+0.01","v":1.02},"Device",null,"\nISO 14155?","INPUT","The ISO 14155 are internationally accepted standards for the conduct of a medical device trial; compliance with the ISO 14155 is a standard condition of ethical approval. Site staff should hold current GCP certification and have a sound knowledge of these principles.","ISO 14155 - Note that there is a cost associated with accessing the ISO standards","https://www.iso.org/standards.htm",{"$f":"IF(E6=\"No\",M6,L6)","v":0},null,"Any Phase",null,"ISO 14155 compliance is a requirement for applicable clinical trials ethically approved by a  HREC."]
[{"$f":"A6+0.01","v":1.03},"IP",null,"The National Statement?","INPUT","The National Statement on Ethical Conduct in Human Research consists of a series of guidelines made in accordance with the National Health and Medical Research Council (NHMRC). Compliance with the National Statement is a prerequisite for receipt of NHMRC funding.  ",{"$f":"HYPERLINK(\"https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018\",\"The National Statement\")","v":"The National Statement"},null,{"$f":"IF(E7=\"No\",M7,L7)","v":0},null,"Any Phase",null,"Adherence to the National Statement is a requirement for clinical trials ethically approved by a HREC. "]
[null,"Device",null,null,"INPUT",null,null,"https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018",{"$f":"IF(E8=\"No\",M7,L7)","v":0}]
[{"$f":"A7+0.01","v":1.04},"IP","Does your site have access to and review the following documents","Australian Code of Responsible Research?","INPUT","The Code provides a framework for responsible research conduct that provides a foundation for high-quality research, credibility and community trust in the research endeavour. ",{"$f":"HYPERLINK(\"https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018\",\"Australian Code of Responsible Research\")","v":"Australian Code of Responsible Research"},null,{"$f":"IF(E9=\"No\",M9,L9)","v":0},"sss","Any Phase",null,"The code has broad relevance across all disciplines. Adherence to the code is a prerequisite for the receipt of funding by the NHMRC."]
[null,"Device",null,null,"INPUT",null,null,"https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018",{"$f":"IF(E10=\"No\",M9,L9)","v":0}]
[{"$f":"A9+0.01","v":1.05},"IP",null,"The Australian Clinical Trial Handbook?","INPUT","The Australian Clinical Trial Handbook; this handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. ",{"$f":"HYPERLINK(\"https://www.tga.gov.au/publication/australian-clinical-trial-handbook \",\"The Australian Clinical Trial Handbook\n\")","v":"The Australian Clinical Trial Handbook\n"},null,{"$f":"IF(E11=\"No\",M11,L11)","v":0},null,"Any Phase",null,"Highly recommended resource for trial sponsors, HRECs, investigators and approving institutions to understand their roles and responsibilities under the therapeutic goods legislation. "]
[null,"Device",null,null,"INPUT",null,null,"https://www.tga.gov.au/publication/australian-clinical-trial-handbook\n\n",{"$f":"IF(E12=\"No\",M11,L11)","v":0}]
[{"$f":"A11+0.01","v":1.06},"IP",null,"The EMA Guidance on Early Phase Research?","INPUT","The Therapeutic Goods Administration (TGA) endorse the European Medicines Agency (EMA) recommendations on appropriately managing risk in first in human clinical trials with investigational medicinal products. The guidance also provides recommendations on sentinel dosing.",{"$f":"HYPERLINK(\"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf \",\"The EMA Guidance on Early Phase Research\")","v":"The EMA Guidance on Early Phase Research"},"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf\n",{"$f":"IF(E13=\"No\",M13,L13)","v":0},null,"Early Phase",null,"Highly recommended early phase guidance available within the Australian clinical trial handbook;  TGA endorsed guidance.   "]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.tga.gov.au/book-page/clinical-trial-phases-and-stages\",\"TGA Clincial Trial Phases and Stages\")","v":"TGA Clincial Trial Phases and Stages"},"https://www.tga.gov.au/book-page/clinical-trial-phases-and-stages"]
[{"$f":"A13+0.01","v":1.07},"IP",null,"Guidelines for Research Involving Aboriginal and Torres Island Peoples?","INPUT","Establishes a set of principles to ensure research is safe, respectful, responsible, of high quality and of benefit to Aboriginal and Torres Strait Islander people and communities. ",{"$f":"HYPERLINK(\"https://www.nhmrc.gov.au/about-us/resources/ethical-conduct-research-aboriginal-and-torres-strait-islander-peoples-and-communities\",\"Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and Communities\")","v":"Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and Communities"},null,{"$f":"IF(E15=\"No\",M15,L15)","v":0},null,"Any Phase",null,"Highly recommended guidance for researchers and stakeholders in developing beneficial research practices for Aboriginal and Torres Strait Islander people and communities. "]
[null,"Device",null,null,"INPUT",null,null,"https://www.nhmrc.gov.au/about-us/resources/ethical-conduct-research-aboriginal-and-torres-strait-islander-peoples-and-communities",{"$f":"IF(E16=\"No\",M15,L15)","v":0}]
[{"$f":"A15+0.01","v":1.08},"IP","Is your site aware of future developments in research policy?","National Model of Clinical Governance?","INPUT","The Commission is developing a national Clinical Trials Governance Framework as a first step towards nationally consistent accreditation of health services undertaking clinical trials in Australia. Accreditation rollout will commence in 2021.",{"$f":"HYPERLINK(\"https://www.safetyandquality.gov.au/our-work/clinical-trials/\",\"National Model of Clinical Governance website\")","v":"National Model of Clinical Governance website"},"https://www.safetyandquality.gov.au/our-work/clinical-trials/",{"$f":"IF(E17=\"No\",M17,L17)","v":0},null,"INPUT",null,"National accreditation is planned for future roll out and is not immediately applicable. However, links may be of interest to interested stakeholders.  "]
[null,"Device",null,null,"INPUT",null,{"$f":"HYPERLINK(\"https://www.safetyandquality.gov.au/sites/default/files/migrated/National-Model-Clinical-Governance-Framework.pdf\",\"National Model of Clinical Governance Framework pdf document\")","v":"National Model of Clinical Governance Framework pdf document"},"https://www.safetyandquality.gov.au/sites/default/files/migrated/National-Model-Clinical-Governance-Framework.pdf \n\n\n\n",{"$f":"IF(E18=\"No\",M17,L17)","v":0}]
[{"$f":"A17+0.01","v":1.0900000000000001},"IP",null,"National Certification Scheme for the ethics review of multi-centre research?","INPUT","National Certification Scheme was developed to enable the single ethics and scientific review of human research that is occurring at multiple institutions in Australia. NHMRC certified HRECs are included in document. Improvements to the scheme are underway. ",{"$f":"HYPERLINK(\"https://www.nhmrc.gov.au/research-policy/ethics/national-certification-scheme-ethics-review-multi-centre-research\",\"List of NHMRC certified HRECS\")","v":"List of NHMRC certified HRECS"},null,{"$f":"IF(E19=\"No\",M19,L19)","v":0},null,"INPUT",null,"Important information for any researchers working within the National Mutual Acceptance (NMA)."]
[null,"Device",null,null,"INPUT",null,null,"https://www.nhmrc.gov.au/research-policy/ethics/national-certification-scheme-ethics-review-multi-centre-research",{"$f":"IF(E20=\"No\",M19,L19)","v":0}]
[{"$f":"A19+0.01","v":1.1000000000000001},"IP","Is your site aware of the following generic resource links","Australian Clinical Trials: Resources for Researchers?","INPUT","Information and guidance designed to assist site staff in conducting a clinical trial and becoming affiliated with a clinical trials network. Resources include a clinical trials toolkit as well as information to guide site staff in trial design, feasibility, start-up and trial conduct.",{"$f":"HYPERLINK(\"https://www.australianclinicaltrials.gov.au/researchers\",\"Australian Clinical Trials: Resources for Researchers\")","v":"Australian Clinical Trials: Resources for Researchers"},null,{"$f":"IF(E21=\"No\",M21,L21)","v":0},null,"Any Phase",null,"Recommended for sponsors, researchers, institutions and stakeholders interested in accessing current clinical trial guidance and resources. "]
[null,"Device",null,null,"INPUT",null,null,"https://www.australianclinicaltrials.gov.au/researchers",{"$f":"IF(E22=\"No\",M21,L21)","v":0}]
[{"$f":"A21+0.01","v":1.1100000000000001},"IP",null,"TGA SME Assist?","INPUT","TGA's Small to Medium Enterprises (SME) Assist is designed to provide guidance to SMEs, researchers and start-ups to understand their regulatory and legislative obligations.  ",{"$f":"HYPERLINK(\"https://www.tga.gov.au/sme-assist\",\"SME Assist\")","v":"SME Assist"},null,{"$f":"IF(E23=\"No\",M23,L23)","v":0},null,"Any Phase",null,"Highly recommended guidance for SMEs, researchers, start-ups in navigating the TGA regulation and legislation. "]
[null,"Device",null,null,"INPUT",null,null,"https://www.tga.gov.au/sme-assist",{"$f":"IF(E24=\"No\",M23,L23)","v":0}]
[{"$f":"A23+0.01","v":1.1200000000000001},"IP",null,"NHMRC Good Practice Process Site Assessment Guidance?","INPUT","Guidance to streamline the site assessment and authorisation of clinical trials and improve clinical trial start-up times.",{"$f":"HYPERLINK(\"https://www.nhmrc.gov.au/about-us/publications/nhmrc-good-practice-process-site-assessment-and-authorisation-clinical-trials#block-views-block-file-attachments-content-block-1\",\"NHMRC Good Practice Process Site Assessment Guidance \")","v":"NHMRC Good Practice Process Site Assessment Guidance "},null,{"$f":"IF(E25=\"No\",M25,L25)","v":0},null,"Any Phase",null,"Recommended feasibility/ start-up guidance for all clinical trial sites. "]
[null,"Device",null,null,"INPUT",null,null,"https://www.nhmrc.gov.au/about-us/publications/nhmrc-good-practice-process-site-assessment-and-authorisation-clinical-trials#block-views-block-file-attachments-content-block-1",{"$f":"IF(E26=\"No\",M25,L25)","v":0}]
[{"$f":"A25+0.01","v":1.1300000000000001},"IP",null,"Medicines Australia Compensation Guidelines?","INPUT","Guidelines for compensation for injury resulting from participation in a company-sponsored clinical trial.",{"$f":"HYPERLINK(\"https://medicinesaustralia.com.au/wp-content/uploads/sites/52/2010/09/Clnical-Trials-Compensation-Guidelines-1.pdf\",\"Medicines Australia Compensation Guidelines\")","v":"Medicines Australia Compensation Guidelines"},null,{"$f":"IF(E27=\"No\",M27,L27)","v":0},null,"Any Phase",null,"Highly recommended guidelines. "]
[null,"Device",null,null,"INPUT",null,null,"https://medicinesaustralia.com.au/wp-content/uploads/sites/52/2010/09/Clnical-Trials-Compensation-Guidelines-1.pdf",{"$f":"IF(E28=\"No\",M27,L27)","v":0}]
[{"$f":"A27+0.01","v":1.1400000000000001},"IP",null,"Global Health Trials : Templates and Tools for Clinical Research?","INPUT","Downloadable Templates and Tools for Clinical Research that may be useful resources to review and modify to suit your site needs.","Resource and SOP site templates",null,{"$f":"IF(E29=\"No\",M29,L29)","v":0},null,"Any Phase",null,"Good resources to explore."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E30=\"No\",M29,L29)","v":0}]

{"sheet":"2.Safety","index":2,"n_rows":21,"n_cols":13,"rows_kept":21,"cut":false,"hidden":false,"merged":[[3,10,4,10],[3,11,4,11],[3,12,4,12],[3,13,4,13],[3,14,4,14],[19,0,20,0],[15,10,18,10],[15,11,18,11],[15,12,18,12],[15,13,18,13],[15,0,18,0],[15,2,18,2],[15,3,18,3],[15,9,18,9],[19,2,20,2],[15,4,16,4],[17,4,18,4],[15,5,16,5],[17,5,18,5],[0,9,1,9],[0,0,1,8],[3,0,4,0],[3,3,4,3],[3,6,4,6],[3,5,4,5],[3,7,4,7],[3,9,4,9],[13,0,14,0],[3,2,14,2],[13,3,14,3],[13,6,14,6],[7,4,8,4],[7,0,10,0],[7,3,10,3],[11,0,12,0],[11,3,12,3],[5,0,6,0],[5,3,6,3],[5,6,6,6],[9,4,10,4],[11,9,12,9],[9,9,10,9],[19,9,20,9],[13,7,14,7],[13,9,14,9],[5,7,6,7],[15,8,16,8],[17,8,18,8],[7,8,8,8],[9,8,10,8]]}
["Safety Management ",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If other","If No"]
[2.0099999999999998,"IP","Does your site have access to the following safety measures?","Is there a medical officer contactable/available in the event of an emergency 24 hours per day?","INPUT","Principal Investigator (PI) contact details should be provided to participant in the Participant Information Consent Form (PICF).  Contact details for non-urgent or non-medical issues shall also be provided, in addition to emergency contact information for after hours.","NA","n/a",{"$f":"IF(E4=\"NO\",M4,L4)","v":0},null,"Any Phase",null,"This is a mandatory requirement for ICFs."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E5=\"NO\",M4,L4)","v":0}]
[{"$f":"A4+0.01","v":2.0199999999999996},"IP",null,"Procedure for notifying the Principal Investigator (PI) or delegate in the event of a clinically significant result or serious adverse event? ","INPUT","Vendors such as a Laboratory  or imaging vendor should contact the PI or Sub-I if a clinically significant result is seen that might require immediate follow up or have safety concerns. In the event that a Serious Adverse Event occurs when the Co-ordinating Principal Investigator (C/PI) is not present a procedure should be in place to notify the C/PI of this.","NA","n/a",{"$f":"IF(E6=\"NO\",M6,L6)","v":0},null,"Any Phase",null,"Consider implementation."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E7=\"NO\",M6,L6)","v":0}]
[{"$f":"A6+0.01","v":2.0299999999999994},"IP",null,"Advanced Life Support (Crash cart), oxygen, patient/participant call bells, staff emergency situation procedure and adequately trained staff?","INPUT","Per EMA guidelines, trials should take place under close supervision during and after dosing. Units need immediate access to appropriately qualified staff for resuscitating and stabilising individuals in an acute emergency. Practiced procedure should also be in place for the transfer of patients to an emergency or ICU department.\n","EMA Guidance on Early Phase Research","https://www.tga.gov.au/book-page/clinical-trial-phases-and-stages",{"$f":"IF(E8=\"NO\",M8,L8)","v":0},null,"Any Phase",null,"Practice procedure and emergency safety equipment should be proportionate to assessed risk."]
[null,"IP",null,null,null,null,"MHRA UK guidance for Phase 1 Site accredication - refer to page 9 for site medical emergency and facility requirements","https://www.gov.uk/guidance/mhra-phase-i-accreditation-scheme"]
[null,"Device",null,null,"INPUT",null,"EMA Guidance on Early Phase Research","https://www.tga.gov.au/book-page/clinical-trial-phases-and-stages",{"$f":"IF(E10=\"NO\",M8,L8)","v":0}]
[null,"Device",null,null,null,null,"MHRA UK guidance for Phase 1 Site accredication - refer to page 9 for site medical emergency and facility requirements","https://www.gov.uk/guidance/mhra-phase-i-accreditation-scheme"]
[{"$f":"A8+0.01","v":2.0399999999999991},"IP",null,"An agreement with a hospital for transferring patients requiring emergency interventions?","INPUT","Per EMA guidelines, procedures should be established between the clinical research unit and nearby emergency or ICU department for the transfer of patients which require emergency interventions.",{"$f":"HYPERLINK(\"https://www.tga.gov.au/book-page/clinical-trial-phases-and-stages\",\"EMA Guidance on Early Phase Research\")","v":"EMA Guidance on Early Phase Research"},"https://www.tga.gov.au/book-page/clinical-trial-phases-and-stages",{"$f":"IF(E12=\"NO\",M12,L12)","v":0},null,"Any Phase",null,"This safety measure is an important step in minimising participant risk. "]
[null,"Device",null,null,"INPUT",null,"EMA Guidance on Early Phase Research","https://www.tga.gov.au/book-page/clinical-trial-phases-and-stages",{"$f":"IF(E13=\"NO\",M12,L12)","v":0}]
[{"$f":"A12+0.01","v":2.0499999999999989},"IP",null,"Procedure for the management of adverse reactions?","INPUT","Staff should be trained in how to identify and respond to adverse reactions either secondary to a treatment of procedure.  Training and planning should be considered on a study level. For any double blind study, clear unblinding instructions are required in the protocol. ","NA","n/a",{"$f":"IF(E14=\"NO\",M14,L14)","v":0},null,"Any Phase",null,"This safety measure is an important step in minimising participant risk. "]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E15=\"NO\",M14,L14)","v":0}]
[{"$f":"A14+0.01","v":2.0599999999999987},"IP","Is your site proficient in clinical safety data management?","Do you have procedures for the identification and an awareness of which of the following events require reporting, and in what timeframe?\n- An adverse event or reaction, \n- Unexpected adverse event or reaction, \n- Serious adverse event or reaction, \n- Assessment of the expectedness of an adverse event or reaction? \n- SSI's (significant safety issues)?\n- USADE's (unanticipated serious adverse device effects)?\n- USM's (urgent safety measures)?","INPUT","Site equipped to identify and respond to safety events and reactions.",{"$f":"HYPERLINK(\"https://www.tga.gov.au/publication/note-guidance-clinical-safety-data-management-definitions-and-standards-expedited-reporting\",\"Note for guidance on clinical safety data management: definitions and standards for expedited reporting.\")","v":"Note for guidance on clinical safety data management: definitions and standards for expedited reporting."},"https://www.tga.gov.au/publication/note-guidance-clinical-safety-data-management-definitions-and-standards-expedited-reporting",{"$f":"IF(E16=\"NO\",M16,L16)","v":0},null,"Any Phase",null,"Site not educated in TGA safety principles, definitions or mandated reporting timeframes."]
[null,"IP",null,null,null,null,{"$f":"G19","v":"NHMRC : Safety Monitoring and Reporting in clinical trials involving Therapeutic Goods"},"http://www.clinicaltrialsalliance.org.au/wp-content/uploads/2015/03/ACTA_Safety_Reporting_Submission_FINAL_COMBINED.pdf"]
[null,"Device",null,null,"INPUT","Site equipped to identify and respond to safety events and reactions.",{"$f":"G16","v":"Note for guidance on clinical safety data management: definitions and standards for expedited reporting."},"https://www.tga.gov.au/publication/note-guidance-clinical-safety-data-management-definitions-and-standards-expedited-reporting",{"$f":"IF(E18=\"NO\",M16,L16)","v":0}]
[null,"Device",null,null,null,null,"NHMRC : Safety Monitoring and Reporting in clinical trials involving Therapeutic Goods","hhttp://www.clinicaltrialsalliance.org.au/wp-content/uploads/2015/03/ACTA_Safety_Reporting_Submission_FINAL_COMBINED.pdf"]
[{"$f":"A16+0.01","v":2.0699999999999985},"IP","Is your site aware of the reporting requirements for the following?","Reporting of serious breaches of GCP or the protocol?","INPUT","Staff should be trained in how to identify GCP and protocol non-compliance, including how to respond and an overview of reporting pathways.",{"$f":"HYPERLINK(\"https://www.australianclinicaltrials.gov.au/sites/default/files/content/For%20researchers/Guidance%20on%20the%20Reporting%20of%20Serious%20Breaches%20of%20GCP.pdf\",\"Reporting of Serious Breaches of Good Clinical Practice or the Protocol for Trials Involving Therapeutic Goods.\")","v":"Reporting of Serious Breaches of Good Clinical Practice or the Protocol for Trials Involving Therapeutic Goods."},"https://www.australianclinicaltrials.gov.au/sites/default/files/content/For%20researchers/Guidance%20on%20the%20Reporting%20of%20Serious%20Breaches%20of%20GCP.pdf",{"$f":"IF(E20=\"No\",M20,L20)","v":0},null,"Any Phase",null,"Site at risk of not adhering to non-compliance reporting requirements mandated by the TGA."]
[null,"Device",null,"Reporting of serious breaches of ISO1555 or the protocol?","INPUT","Staff should be trained in how to identify non-compliance with ISO 14155 and the protocol, including how to respond and an overview of reporting pathways.","Reporting of Serious Breaches of Good Clinical Practice or the Protocol for Trials Involving Therapeutic Goods.","https://www.australianclinicaltrials.gov.au/sites/default/files/content/For%20researchers/Guidance%20on%20the%20Reporting%20of%20Serious%20Breaches%20of%20GCP.pdf",{"$f":"IF(E21=\"No\",M20,L20)","v":0},null,"Any Phase",null,"Site at risk of not adhering to non-compliance reporting requirements mandated by the TGA."]

{"sheet":"3.Staff","index":3,"n_rows":19,"n_cols":13,"rows_kept":19,"cut":false,"hidden":false,"merged":[[13,0,18,0],[13,10,18,10],[13,2,18,2],[13,3,18,3],[13,5,18,5],[13,4,15,4],[16,4,18,4],[13,13,18,13],[13,7,18,7],[13,9,18,9],[13,11,18,11],[13,12,18,12],[13,8,15,8],[16,8,18,8],[11,11,12,11],[11,12,12,12],[11,13,12,13],[9,9,10,9],[9,11,10,11],[9,12,10,12],[9,13,10,13],[7,6,8,6],[11,0,12,0],[11,10,12,10],[11,3,12,3],[11,5,12,5],[11,9,12,9],[11,6,12,6],[11,7,12,7],[9,0,10,0],[9,10,10,10],[9,3,10,3],[9,5,10,5],[9,7,10,7],[5,11,6,11],[5,13,6,13],[7,0,8,0],[7,10,8,10],[7,2,12,2],[7,3,8,3],[7,5,8,5],[9,6,10,6],[7,7,8,7],[5,12,6,12],[7,9,8,9],[7,11,8,11],[3,2,6,2],[3,3,4,3],[7,12,8,12],[7,13,8,13],[5,0,6,0],[5,10,6,10],[5,3,6,3],[5,5,6,5],[5,6,6,6],[5,7,6,7],[5,9,6,9],[3,5,4,5],[0,9,1,9],[0,0,1,8],[3,13,4,13],[3,0,4,0],[3,10,4,10],[3,9,4,9],[3,11,4,11],[3,12,4,12],[3,6,4,6]]}
["Staffing",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If other","If No"]
[{"$f":"3.01","v":3.01},"Device","Does your site comply with the following Safe Workplace Practices","Your state’s safe workplace practises?","INPUT","This is a legislative requirement.",{"$f":"HYPERLINK(\"https://www.safeworkaustralia.gov.au/\",\"Please refer to your state’s safe workplace website.    \n\n\n\")","v":"Please refer to your state’s safe workplace website.    \n\n\n"},"https://www.safeworkaustralia.gov.au/\n\n",{"$f":"IF(E4=\"no\",M4,L4)","v":0},null,"Any Phase",null,"Please consider your state's compliance requirements."]
[null,"IP",null,null,"INPUT",null,null,"https://www.safework.sa.gov.au/resources/workplace-inspection-checklist",{"$f":"IF(E5=\"no\",M4,L4)","v":0}]
[{"$f":"A4+0.01","v":3.0199999999999996},"Device",null,"Your institutions safe workplace guidance and any specific work procedures?","INPUT","Refer to your institution's policies and procedures.","NA","n/a",{"$f":"IF(E6=\"no\",M6,L6)","v":0},null,"Any Phase",null,"Please consider your institutions policies and procedures."]
[null,"IP",null,null,"INPUT",null,null,null,{"$f":"IF(E7=\"no\",M6,L6)","v":0}]
[{"$f":"A6+0.01","v":3.0299999999999994},"Device","Does your site have an adequate and appropriate staffing (Education and Experience): \n","Does your site have a Site Trial Manager/Coordinator who is dedicated point of contact for sponsor/CRO?","INPUT","This may be dependent on study type and volume of participants.","NA","https://workload.asco.org/user\n\n",{"$f":"IF(E8=\"no\",M8,L8)","v":0},null,"Any Phase",null,"Consider assigning a dedicated staff member to act as central point of contact for Sponsors/Contract Research Organisations (CROs). "]
[null,"IP",null,null,"INPUT",null,null,null,{"$f":"IF(E9=\"no\",M8,L8)","v":0}]
[{"$f":"A8+0.01","v":3.0399999999999991},"Device",null,"Does your staffing matrix consider;\n- Timely PI/coordinator response to safety events\n- Data entry and reporting requirements\n- Screening and coordination of a manageable ratio of participants\n- Access to on-call/temporary staff to meet fluctuating requirements?","INPUT","You need to consider what staffing mix is required to undertake the study. You need to identify who would complete each of the assessments in the study protocol. Once this has been done you can identify any new staff or skills required to execute the protocol.",{"$f":"HYPERLINK(\"https://workload.asco.org/user \",\"ASCO have a Clinical Trial Workload Assessment Tool that is available to ASCO members\n\n\")","v":"ASCO have a Clinical Trial Workload Assessment Tool that is available to ASCO members\n\n"},"https://pdfs.semanticscholar.org/c1ed/0172376068cdc3e7c291eafd734da505a8a7.pdf",{"$f":"IF(E10=\"no\",M10,L10)","v":0},null,"Any Phase",null,"Consider developing a Resource Management and Risk Management Plans for new and existing trials."]
[null,"IP",null,null,"INPUT",null,null,null,{"$f":"IF(E11=\"no\",M10,L10)","v":0}]
[{"$f":"A10+0.01","v":3.0499999999999989},"Device",null,"Research Administrative Management:\n- adequately trained and experienced staff to assist with feasibility, \n- budget and contract negotiation,\n- ethics and research governance authorisation; \n- and oversight of SOPs (creation, implementation and evaluation)?","INPUT","Site feasibility, budget and contract negotiation, submission of Ethics application and Site Specific Application (SSA) are critical start-up activities that require a dedicated staff. Oversight of SOPs are also necessary to ensure the site is operating at quality standards.","NA","n/a",{"$f":"IF(E12=\"no\",M12,L12)","v":0},null,"Any Phase",null,"Consider a dedicated staff for regulatory and start-up activities at site level or seek assistance or training from someone with this experience. "]
[null,"IP",null,null,"INPUT",null,null,null,{"$f":"IF(E13=\"no\",M12,L12)","v":0}]
[{"$f":"A12+0.01","v":3.0599999999999987},"Device","Do your staff have the appropriate training and experience:\n","To run early phase trials?\n(Eg - A study coordinator should have appropriate trial experience before working in early phase\n- An Investigator should have experience in First in Human (FIH) and Phase 1b.)","INPUT","In early phase studies sites usually receive less developed protocols and study documentation during start up, compared with later phase studies where documentation is largely near final when first provided to site. Selected study personnel should expect to review study documents and provide feedback on feasibility, procedures and logistics during the start-up process.",{"$f":"HYPERLINK(\"http://praxisaustralia.com.au/\",\"Clinical Trialist Training Courses - PRAXIS\")","v":"Clinical Trialist Training Courses - PRAXIS"},"http://praxisaustralia.com.au/",{"$f":"IF(E14=\"no\",M14,L14)","v":0},null,"Any Phase",null,"Consider reviewing relevant documents as a team rather than an individual. Be prepared to allow additional time during start up  to review documents in detail."]
[null,"Device",null,null,null,null,"Site Training resources from SCRS"]
[null,"Device",null,null,null,null,"MHRA UK guidance on Phase 1 Site accredication - refer page 10 for staff experience"]
[null,"IP",null,null,"INPUT",null,{"$f":"HYPERLINK(\"http://praxisaustralia.com.au/\",\"Clinical Trialist Training Courses - PRAXIS\")","v":"Clinical Trialist Training Courses - PRAXIS"},null,{"$f":"IF(E17=\"no\",M14,L14)","v":0}]
[null,"IP",null,null,null,null,"Site Training resources from SCRS"]
[null,"IP",null,null,null,null,"MHRA UK guidance on Phase 1 Site accredication - refer page 10 for staff experience"]

{"sheet":"4.Facility","index":4,"n_rows":21,"n_cols":13,"rows_kept":21,"cut":false,"hidden":false,"merged":[[19,10,20,10],[19,11,20,11],[19,12,20,12],[19,9,20,9],[19,0,20,0],[19,3,20,3],[15,2,20,2],[19,5,20,5],[19,6,20,6],[17,0,18,0],[17,3,18,3],[17,6,18,6],[15,5,16,5],[17,5,18,5],[17,11,18,11],[3,0,4,0],[3,2,4,2],[3,3,4,3],[3,6,4,6],[3,5,4,5],[3,13,4,13],[3,9,4,9],[3,10,4,10],[3,11,4,11],[3,12,4,12],[11,13,12,13],[9,0,10,0],[7,0,8,0],[7,3,8,3],[7,6,8,6],[7,13,8,13],[7,9,8,9],[7,10,8,10],[7,11,8,11],[7,12,8,12],[9,13,10,13],[9,12,10,12],[9,11,10,11],[9,10,10,10],[11,0,12,0],[11,3,12,3],[5,13,6,13],[5,12,6,12],[5,11,6,11],[5,10,6,10],[7,5,8,5],[5,9,6,9],[11,6,12,6],[5,2,14,2],[5,5,6,5],[5,6,6,6],[5,3,6,3],[9,3,10,3],[9,5,10,5],[13,12,14,12],[11,9,12,9],[11,10,12,10],[11,11,12,11],[11,12,12,12],[13,9,14,9],[13,10,14,10],[13,11,14,11],[0,9,1,9],[0,0,1,8],[17,10,18,10],[15,10,16,10],[15,9,16,9],[15,6,16,6],[15,3,16,3],[15,0,16,0],[13,0,14,0],[13,3,14,3],[13,6,14,6],[11,5,12,5],[13,5,14,5],[5,0,6,0],[9,6,10,6],[9,9,10,9],[17,13,18,13],[15,13,16,13],[15,12,16,12],[15,11,16,11],[17,9,18,9],[17,12,18,12]]}
["Facility",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If Other","If No"]
[4.01,"IP","Does your site have the following Participant/Patient facilities:","Adequate participant areas and equipment to conduct and oversee treatment, procedures and participant monitoring?","INPUT","E.g. Day centre beds/chairs, rooms for screening, consultation, examination, participant emergency call bells, adequate participant monitoring area.","Transcelerate Site Facility Profile/Proforma that can be used for the whole Facilities section",null,{"$f":"IF(E4=\"no\",M4,L4)","v":0},null,"Any Phase",null,"Study appropriate space and equipment must be available to ensure safe and effective participant oversight."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E5=\"no\",M4,L4)","v":0}]
[{"$f":"A4+0.01","v":4.0199999999999996},"IP","Does your site have the following in relation to Site Equipment","Lockable storage area for clinical trial information, test kits, trial specific equipment?","INPUT","E.g. Blood pressure monitoring, thermometer, ECG machines, weight scales, phlebotomy supplies. Trial specific requirements should be assessed at feasibility.","NA",null,{"$f":"IF(E6=\"no\",M6,L6)","v":0},null,"Any Phase",null,"It is important to ensure trial supplies and equipment are available to accurately measure and record study assessments."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E7=\"no\",M6,L6)","v":0}]
[{"$f":"A6+0.01","v":4.0299999999999994},"IP",null,"Equipment registers, including physical location and maintenance schedule?","INPUT","Asset register of all equipment, including maintenance logs (inc. calibration records).","NA",null,{"$f":"IF(E8=\"no\",M8,L8)","v":0},null,"Any Phase",null,"Sponsor may require information on availability of equipment."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E9=\"no\",M8,L8)","v":0}]
[{"$f":"A8+0.01","v":4.0399999999999991},"IP",null,"Power generators for instances of outages – including documented quality control (QC) testing?","INPUT","Important for temperature sensitive products, continuous infusions or sample/data integrity.","NA",null,{"$f":"IF(E10=\"no\",M10,L10)","v":0},null,"Any Phase",null,"Refer to institution policy or contingency plans."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E11=\"no\",M10,L10)","v":0}]
[{"$f":"A10+0.01","v":4.0499999999999989},"IP",null,"Other departmental or vendor – e.g. Pharmacy, Radiology, Ophthalmology, etc?","INPUT","Studies often require assessments by other departments/specialists. Some departments or vendors may need to perform assessments in line with specific requirements (such as RECIST imaging) or have certified processes (such as NATA accredited laboratories).","NA",null,{"$f":"IF(E12=\"no\",M12,L12)","v":0},null,"Any Phase",null,"Vendor requirements should be fulfilled to promote optimal, quality data collection."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E13=\"no\",M12,L12)","v":0}]
[{"$f":"A12+0.01","v":4.0599999999999987},"IP",null,"Lockable storage area for clinical trial information, test kits, trial specific equipment?","INPUT","Sponsors provide a quantity of study kits that  require room for secure storage and access.","NA",null,{"$f":"IF(E14=\"no\",M14,L14)","v":0},null,"Any Phase",null,"Without appropriate, secure storage space, the trial site may not meet feasibility requirements."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E15=\"no\",M14,L14)","v":0}]
[{"$f":"A14+0.01","v":4.0699999999999985},"IP","Does your site have adequate Office / Admin facilities:","Adequate IT capabilities; including computer(s), printers, photocopier, scanner, high speed internet?","INPUT","To support data entry and administrative trial activities. IT support should also be considered.","NA",null,{"$f":"IF(E16=\"no\",M16,L16)","v":0},null,"Any Phase",null,"Site at risk of not completing data entry requirements by sponsor mandated deadlines."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E17=\"no\",M16,L16)","v":0}]
[{"$f":"A16+0.01","v":4.0799999999999983},"IP",null,"Standard time (24-hour) and date format?","INPUT","To ensure consistent reporting by all study staff.","NA",null,{"$f":"IF(E18=\"no\",M18,L18)","v":0},null,"Any Phase",null,"Increased risk of reporting inaccuracies in date and time of data collection."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E19=\"no\",M18,L18)","v":0}]
[{"$f":"A18+0.01","v":4.0899999999999981},"IP",null,"Space for study monitoring visits?","INPUT","To ensure that the study sponsor has access to the site files for their audit purposes.","NA",null,{"$f":"IF(E20=\"no\",M20,L20)","v":0},null,"Any Phase",null,"Remote monitoring may have to be implemented that may be an extra burden on the site."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E21=\"no\",M20,L20)","v":0}]

{"sheet":"5.Device","index":5,"n_rows":7,"n_cols":13,"rows_kept":7,"cut":false,"hidden":false,"merged":[[3,2,5,2],[0,9,1,9],[0,0,1,8]]}
["Device Handling  ",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If Other","If No"]
[5.01,"Device","Does your site have the following for Investigational Device handling","Is there locked storage space for investigational device? \nDoes your site have a procedure for accessing investigational device for use in the study (chain of custody?)","INPUT","Early Phase investigational devices are generally not yet approved by the Therapeutic Goods Administration (TGA). Therefore, it has to be assured that they are only used on study patients.","NA","n/a",{"$f":"IF(E4=\"no\",M4,L4)","v":0},null,"Early Phase",null,"Strongly consider creating such space. Also consider that the investigational product needs to be available on short notice at all times at which study patients might be treated."]
[{"$f":"A4+0.01","v":5.0199999999999996},"Device",null,"Is there a plan for training for involved staff (PI, co-PIs, nursing and theatre staff) in the use of investigational device?","INPUT","The use of the investigational product might differ from existing products that the investigators are familiar with. It is also important that supporting staff (scrub nurse etc.) are trained on the investigational device.","Covered in staffing TAB","n/a",{"$f":"IF(E5=\"no\",M5,L5)","v":0},null,"Early Phase",null,"Ask the sponsor to conduct investigational product training not only for the investigators but also for nursing and theatre staff."]
[{"$f":"A5+0.01","v":5.0299999999999994},"Device",null,"Do you  have a procedure for device handling including;\n- How expired stock is monitored and reordered?\n- Maintenance and accountability of stock?\n- Stock integrity, including temperature monitoring?","INPUT","Since the investigational product is kept locked away from standard stock, special care has to be taken to monitor its use-before-dates.","NA","n/a",{"$f":"IF(E6=\"no\",M6,L6)","v":0},null,"Any Phase",null,"Consider preparing a short document describing this process and make sure relevant staff are aware of it."]
[5.0399999999999991,"Device","Are you aware of the following Generic Resource Links","MTAA website?","INPUT",null,{"$f":"HYPERLINK(\"https://www.mtaa.org.au/clinical-trials-medical-devices-basics#targetText=Description&targetText=It%20is%20typically%20used%20to,means%20such%20as%20bench%20testing.\",\"MTAA website\")","v":"MTAA website"},"https://www.mtaa.org.au/clinical-trials-medical-devices-basics#targetText=Description&targetText=It%20is%20typically%20used%20to,means%20such%20as%20bench%20testing.",{"$f":"IF(E7=\"no\",M7,L7)","v":0},null,"Any Phase",null,"NA"]

{"sheet":"6.QAQM","index":6,"n_rows":54,"n_cols":13,"rows_kept":54,"cut":false,"hidden":false,"merged":[[3,12,4,12],[3,13,4,13],[5,12,6,12],[5,11,6,11],[3,0,4,0],[3,2,16,2],[3,3,4,3],[3,6,4,6],[3,9,4,9],[3,10,4,10],[5,10,6,10],[5,9,6,9],[5,6,6,6],[5,3,6,3],[5,0,6,0],[7,0,8,0],[7,3,8,3],[7,6,8,6],[3,11,4,11],[7,13,8,13],[9,13,10,13],[9,12,10,12],[9,11,10,11],[9,10,10,10],[7,9,8,9],[7,10,8,10],[7,11,8,11],[7,12,8,12],[11,9,12,9],[11,10,12,10],[11,11,12,11],[11,12,12,12],[9,0,10,0],[11,0,12,0],[11,3,12,3],[11,6,12,6],[9,9,10,9],[9,6,10,6],[9,3,10,3],[13,3,14,3],[13,0,14,0],[15,0,16,0],[15,3,16,3],[15,6,16,6],[13,12,14,12],[13,11,14,11],[13,10,14,10],[13,9,14,9],[15,12,16,12],[17,10,18,10],[15,9,16,9],[15,10,16,10],[15,11,16,11],[19,13,20,13],[21,13,22,13],[13,6,14,6],[17,9,18,9],[17,6,18,6],[15,13,16,13],[17,13,18,13],[17,12,18,12],[17,11,18,11],[21,11,22,11],[21,12,22,12],[19,6,20,6],[19,9,20,9],[19,10,20,10],[19,11,20,11],[19,12,20,12],[23,12,24,12],[23,13,24,13],[21,10,22,10],[21,9,22,9],[21,6,22,6],[25,13,26,13],[25,12,26,12],[25,11,26,11],[23,6,24,6],[23,9,24,9],[23,10,24,10],[23,11,24,11],[25,10,26,10],[25,9,26,9],[25,6,26,6],[27,12,28,12],[29,12,30,12],[29,11,30,11],[29,10,30,10],[29,9,30,9],[27,6,28,6],[27,9,28,9],[27,10,28,10],[27,11,28,11],[29,6,30,6],[29,3,30,3],[29,0,30,0],[17,2,30,2],[17,0,18,0],[19,0,20,0],[19,3,20,3],[21,3,22,3],[21,0,22,0],[23,0,24,0],[23,3,24,3],[25,3,26,3],[25,0,26,0],[27,0,28,0],[27,3,28,3],[17,3,18,3],[34,13,35,13],[31,0,33,0],[31,2,33,2],[31,3,33,3],[32,4,33,4],[32,8,33,8],[34,6,35,6],[34,9,35,9],[34,10,35,10],[36,3,37,3],[31,13,33,13],[31,9,33,9],[31,10,33,10],[31,11,33,11],[31,12,33,12],[36,2,37,2],[36,0,37,0],[38,0,39,0],[38,2,39,2],[38,3,39,3],[36,10,37,10],[36,9,37,9],[36,6,37,6],[36,13,37,13],[36,12,37,12],[36,11,37,11],[38,11,39,11],[38,12,39,12],[34,0,35,0],[34,2,35,2],[34,3,35,3],[34,11,35,11],[34,12,35,12],[40,12,41,12],[40,11,41,11],[40,10,41,10],[38,6,39,6],[38,9,39,9],[38,10,39,10],[40,5,41,5],[44,3,45,3],[44,0,45,0],[46,0,47,0],[46,3,47,3],[48,3,49,3],[48,0,49,0],[50,0,51,0],[50,3,51,3],[40,9,41,9],[40,6,41,6],[40,3,41,3],[46,5,47,5],[48,5,49,5],[50,5,51,5],[42,13,43,13],[44,13,45,13],[44,12,45,12],[44,11,45,11],[42,6,43,6],[42,9,43,9],[42,10,43,10],[42,11,43,11],[42,5,43,5],[44,5,45,5],[46,13,47,13],[48,13,49,13],[48,12,49,12],[48,11,49,11],[46,6,47,6],[46,9,47,9],[46,10,47,10],[46,11,47,11],[44,10,45,10],[44,9,45,9],[44,6,45,6],[52,0,53,0],[0,9,1,9],[0,0,1,8],[52,6,53,6],[52,3,53,3],[52,2,53,2],[50,12,51,12],[52,12,53,12],[52,11,53,11],[52,10,53,10],[52,9,53,9],[50,6,51,6],[50,9,51,9],[50,10,51,10],[50,11,51,11],[48,10,49,10],[48,9,49,9],[48,6,49,6],[46,12,47,12],[42,12,43,12],[40,2,51,2],[40,0,41,0],[42,0,43,0],[42,3,43,3],[3,5,4,5],[5,5,6,5],[7,5,8,5],[9,5,10,5],[11,5,12,5],[13,5,14,5],[15,5,16,5],[17,5,18,5],[19,5,20,5],[52,5,53,5],[21,5,22,5],[23,5,24,5],[25,5,26,5],[27,5,28,5],[29,5,30,5],[31,5,33,5],[34,5,35,5],[36,5,37,5],[38,5,39,5]]}
["Quality Assurance & Quality Measures",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If Other","If No"]
[6.01,"IP","Does your site have an internal Quality Assurance Procedure?","Does your site have a Quality Assurance (QA) procedure to test the robustness of your site practices, including emergency procedures and data capture? Have you established timelines for these to be tested?","INPUT","Required as per Site Standard Operating Procedures (SOP).","NA",null,{"$f":"IF(E4=\"no\",M4,L4)","v":0},null,"Any Phase",null,"Site potentially not equipped with a contingency plan."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E5=\"no\",M4,L4)","v":0}]
[{"$f":"A4+0.01","v":6.02},"IP",null,"Do you have Source Data Verification (SDV) procedures in place if required?","INPUT","Required as per Site SOP.","NA",null,{"$f":"IF(E6=\"no\",M6,L6)","v":0},null,"Any Phase",null,"Potential for incorrect / inconsistent data capture."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E7=\"no\",M6,L6)","v":0}]
[{"$f":"A6+0.01","v":6.0299999999999994},"IP",null,"Do you have a nominated person to perform the quality assurance?","INPUT","This can be any delegated staff with appropriate experience. ","NA",null,{"$f":"IF(E8=\"no\",M8,L8)","v":0},null,"Any Phase",null,"Site may not be adhering to quality assurance policies."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E9=\"no\",M8,L8)","v":0}]
[{"$f":"A8+0.01","v":6.0399999999999991},"IP",null,"Have you established timelines (i.e. frequency and duration) for the quality assurance activities?","INPUT","Required as per Site SOP.","NA",null,{"$f":"IF(E10=\"no\",M10,L10)","v":0},null,"Any Phase",null,"Site may not be adhering to quality assurance policies."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E11=\"no\",M10,L10)","v":0}]
[{"$f":"A10+0.01","v":6.0499999999999989},"IP",null,"Do your staff have adequate time and opportunity to complete and review source data and queries raised from the source data?","INPUT","To ensure that data capture is accurate and timely.","NA",null,{"$f":"IF(E12=\"no\",M12,L12)","v":0},null,"Any Phase",null,"Potential for inaccurate data recording."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E13=\"no\",M12,L12)","v":0}]
[{"$f":"A12+0.01","v":6.0599999999999987},"IP",null,"Are all study documents, forms and databases contemporaneously updated and accessible for data validation?","INPUT","To ensure that data capture and reporting is accurate and timely.","ALCOA-C Checklist",null,{"$f":"IF(E14=\"no\",M14,L14)","v":0},null,"Any Phase",null,"Site may not be adhering to quality assurance policies."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E15=\"no\",M14,L14)","v":0}]
[{"$f":"A14+0.01","v":6.0699999999999985},"IP",null,"Do you perform a protocol risk assessment prior to implementation?","INPUT","Pre-assessment will enable site to adequately gauge trial requirements and impact on resources.",{"$f":"HYPERLINK(\"https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/343677/Risk-adapted_approaches_to_the_management_of_clinical_trials_of_investigational_medicinal_products.pdf\",\"UK guidance on Risk-adapted Approaches to the \nManagement of Clinical Trials of IMP's\")","v":"UK guidance on Risk-adapted Approaches to the \nManagement of Clinical Trials of IMP's"},null,{"$f":"IF(E16=\"no\",M16,L16)","v":0},null,"Any Phase",null,"Site potentially underestimates impact of trial on resources."]
[null,"Device",null,null,"INPUT",null,null,"https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/343677/Risk-adapted_approaches_to_the_management_of_clinical_trials_of_investigational_medicinal_products.pdf",{"$f":"IF(E17=\"no\",M16,L16)","v":0}]
[{"$f":"A16+0.01","v":6.0799999999999983},"IP","Does your site have evaluation processes in place and a CAPA (Corrective and Preventative Action) process for the following:","Protocol deviations / violations?","INPUT","Required as per GCP Guidelines.","Protocol deviation and training resource",null,{"$f":"IF(E18=\"no\",M18,L18)","v":0},null,"Any Phase",null,"Site not adhering to GCP requirements."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E19=\"no\",M18,L18)","v":0}]
[{"$f":"A18+0.01","v":6.0899999999999981},"IP",null,"Site staff complaints?","INPUT","Required as per Site SOP.","NA",null,{"$f":"IF(E20=\"no\",M20,L20)","v":0},null,"Any Phase",null,"Site may not be adhering to organisational policy and procedures."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E21=\"no\",M20,L20)","v":0}]
[{"$f":"A20+0.01","v":6.0999999999999979},"IP",null,"Site-internal audit / monitoring findings?","INPUT","Required as per Site SOP.","NA",null,{"$f":"IF(E22=\"no\",M22,L22)","v":0},null,"Any Phase",null,"Site may not be adhering to organisational policy and procedures."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E23=\"no\",M22,L22)","v":0}]
[{"$f":"A22+0.01","v":6.1099999999999977},"IP",null,"Study specific monitor visits?","INPUT","To ensure Sponsor requirements are met.","NA",null,{"$f":"IF(E24=\"no\",M24,L24)","v":0},null,"Any Phase",null,"Sponsor monitoring process may be delayed or incomplete."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E25=\"no\",M24,L24)","v":0}]
[{"$f":"A24+0.01","v":6.1199999999999974},"IP",null,"Operational issues identified at your site?","INPUT","Required as per Site SOP.","NA",null,{"$f":"IF(E26=\"no\",M26,L26)","v":0},null,"Any Phase",null,"Site may not be adhering to organisational policy and procedures."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E27=\"no\",M26,L26)","v":0}]
[{"$f":"A26+0.01","v":6.1299999999999972},"IP",null,"Patient withdrawal from study?","INPUT","Required as per study and GCP guidelines.","NA",null,{"$f":"IF(E28=\"no\",M28,L28)","v":0},null,"Any Phase",null,"Site not adhering to GCP requirements."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E29=\"no\",M28,L28)","v":0}]
[{"$f":"A28+0.01","v":6.139999999999997},"IP",null,"Research participants complaints?","INPUT","Required as per GCP and HREC guidelines.","NA",null,{"$f":"IF(E30=\"no\",M30,L30)","v":0},null,"Any Phase",null,"Site not adhering to GCP and HREC requirements."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E31=\"no\",M30,L30)","v":0}]
[{"$f":"A30+0.01","v":6.1499999999999968},"IP","Do you have a CAPA (Corrective and Preventive Action) procedure? Consider the following :","Process for \nIncident identification?\nDevelopment of action plan based on cause analysis?\nAction plan validation and implementation?\nDocumentation of standard operating procedure as a result of CAPA?","INPUT","May be required as per Site SOP.","Serious Breach and CAPA guidance",null,{"$f":"IF(E32=\"no\",M32,L32)","v":0},null,"Any Phase",null,"Site may not be adhering to organisational policy and procedures."]
[null,"Device",null,null,"INPUT",null,"Serious Breach and CAPA guidance",null,{"$f":"IF(E33=\"no\",M32,L32)","v":0}]
[null,"Device",null,null,null,null,"Device focused CAPA tool","n/a"]
[{"$f":"A32+0.01","v":6.1599999999999966},"IP","Does your site have a Participant Management Database?","Do you have a system to capture and record potential trial participants?","INPUT","Can assist in identifying participants and estimating recruitment numbers. Consider your site's patient population and referral networks.  ","CT:IQ Best Practice Guidance for patient recruitment - currently being developed.  Will be available at the end of 2019.  ",null,{"$f":"IF(E35=\"no\",M35,L35)","v":0},null,"Any Phase",null,"Potential for delay in recruiting participants to trials."]
[null,"Device",null,null,"INPUT",null,null,"Add Link once finalised at end of 2019",{"$f":"IF(E36=\"no\",M35,L35)","v":0}]
[{"$f":"A35+0.01","v":6.1699999999999964},"IP","Does your site record and monitor Study Metrics / KPIs?","Do you have a system to capture and record study metrics/KPIs?","INPUT","This system will provide information on site trial activity and can assist in organisation metric reporting requirements.",{"$f":"HYPERLINK(\"https://www.clinicaltrialsarena.com/comment/how-to-design-effective-key-performance-indicators-6078165-2/ \",\"How to design effective KPIs's resource\")","v":"How to design effective KPIs's resource"},null,{"$f":"IF(E37=\"no\",M37,L37)","v":0},null,"Any Phase",null,"Not essential, however it could be a potential barrier to site selection and site improvement. Consider implementing at least Top 5 KPIs."]
[null,"Device",null,null,"INPUT",null,null,"https://www.clinicaltrialsarena.com/comment/how-to-design-effective-key-performance-indicators-6078165-2/\n\n",{"$f":"IF(E38=\"no\",M37,L37)","v":0}]
[{"$f":"A37+0.01","v":6.1799999999999962},"IP","Does your site have a system to capture and record recommended KPIs?","Some examples include :\n1. Current actual recruitment versus target recruitment (%)\n2. Median Calendar Days from Human Research Ethics Committee Office (HREC) submission to HREC approval. \n3. Median Calendar Days from Research Governance Office (RGO) submission to RGO authorisation.\n4. Median calendar days from Contract (CTRA) fully executed to site activation.\n5. Median calendar days from site activation to first patient enrolled on trial?","INPUT","Minimal data set of performance metrics will assist sites in determining efficacy and efficiency in sites performance and assist in eliminating barriers to improve performance. ",{"$f":"HYPERLINK(\"https://www.cancer.nsw.gov.au/data-research/clinical-trials/performance-indicators\",\"Cancer Institute NSW - Performance Indicators\")","v":"Cancer Institute NSW - Performance Indicators"},null,{"$f":"IF(E39=\"no\",M39,L39)","v":0},null,"Any Phase",null,"Potential barrier to site selection, site improvement, site not aware of resourcing issues (e.g. costs, staffing), potential delays in translation to practice. "]
[null,"Device",null,null,"INPUT",null,null,"https://www.cancer.nsw.gov.au/data-research/clinical-trials/performance-indicators",{"$f":"IF(E40=\"no\",M39,L39)","v":0}]
[{"$f":"A39+0.01","v":6.1899999999999959},"IP","Does your site have SOPs covering the following topics:","Do you have resource for the review and monitoring of any GCP compliance updates / trends to ensure quality improvement is maintained at your site? ","INPUT","Description of investigator qualifications, GCP and delegation log procedures, feasibility assessment processes and RGO and HREC requirements.",{"$f":"HYPERLINK(\"https://www.barwonhealth.org.au/images/downloads/Office_for_Research/VMIA%20SOPs%20to%20Achieve%20GCP%20in%20Australian%20Clinical%20Research.pdf\",\"VMIA SOP's - can be referenced for all SOP's in this section\")","v":"VMIA SOP's - can be referenced for all SOP's in this section"},null,{"$f":"IF(E41=\"no\",M41,L41)","v":0},null,"Any Phase",null,"Recommend creating SOP to cover this topic."]
[null,"Device",null,null,"INPUT",null,null,"https://www.barwonhealth.org.au/images/downloads/Office_for_Research/VMIA%20SOPs%20to%20Achieve%20GCP%20in%20Australian%20Clinical%20Research.pdf",{"$f":"IF(E42=\"no\",M41,L41)","v":0}]
[{"$f":"A41+0.01","v":6.1999999999999957},"IP",null,"Training and Quality management?","INPUT","Document procedures for site initiation visits, protocol-specific training and ongoing supplemental training, Outline all QC procedures, CTMS software in use and audit procedures.",{"$f":"HYPERLINK(\"http://praxisaustralia.com.au/resources/categories/clinical-trials-sops?page=2\",\"Praxis SOP's - can re used a reference for all SOP's in this section\")","v":"Praxis SOP's - can re used a reference for all SOP's in this section"},null,{"$f":"IF(E43=\"no\",M43,L43)","v":0},null,"Any Phase",null,"Recommend creating SOP to cover this topic."]
[null,"Device",null,null,"INPUT",null,null,"http://praxisaustralia.com.au/resources/categories/clinical-trials-sops?page=2",{"$f":"IF(E44=\"no\",M43,L43)","v":0}]
[{"$f":"A43+0.01","v":6.2099999999999955},"IP",null,"Participant recruitment?","INPUT","Describe how your organisation facilitates recruitment. Describe consenting processes, privacy and confidentiality of participants and reimbursements. Are there any procedures to reduce risks of over-volunteering if applicable.",{"$f":"HYPERLINK(\"https://www.medicalresearch.nsw.gov.au/clinical-trial-toolkit/\",\"NSW Health SOP's - can be used as a reference for all SOP's in this section\")","v":"NSW Health SOP's - can be used as a reference for all SOP's in this section"},null,{"$f":"IF(E45=\"no\",M45,L45)","v":0},null,"Early Phase",null,"Recommend creating SOP to cover this topic."]
[null,"Device",null,null,"INPUT",null,null,"https://www.medicalresearch.nsw.gov.au/clinical-trial-toolkit/",{"$f":"IF(E46=\"no\",M45,L45)","v":0}]
[{"$f":"A45+0.01","v":6.2199999999999953},"IP",null,"Safety Management?","INPUT","Management and reporting of serious adverse events, including safety monitoring and emergency equipment on site.","NA",null,{"$f":"IF(E47=\"no\",M47,L47)","v":0},null,"Early Phase",null,"Recommend creating SOP to cover this topic."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E48=\"no\",M47,L47)","v":0}]
[{"$f":"A47+0.01","v":6.2299999999999951},"IP",null,"Pharmacy/Device Procedures?","INPUT","Describe procedures for IMP/device delivery, storage, monitoring, accountability and destruction, including chain of custody documentation. Consider the suitability of the administration equipment and potential interactions with the IMP.","NA",null,{"$f":"IF(E49=\"no\",M49,L49)","v":0},null,"Any Phase",null,"Recommend creating SOP to cover this topic."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E50=\"no\",M49,L49)","v":0}]
[{"$f":"A49+0.01","v":6.2399999999999949},"IP",null,"Supplies and vendors?","INPUT","List and describe service agreements with any third party vendors. Maintenance of site equipment can be included here.","NA",null,{"$f":"IF(E51=\"no\",M51,L51)","v":0},null,"Any Phase",null,"Recommend creating SOP to cover this topic."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E52=\"no\",M51,L51)","v":0}]
[{"$f":"A51+0.01","v":6.2499999999999947},"IP","Does your site assess your site capabilities, resources and operational constraints against each protocol requirements?","Consider the requirements, treatment and procedures and staffing, in additional to operational requirements of the protocol and the interoperability with your site capabilities, resources and operational constraints. Have you identified what days study procedures could be conducted (e.g. Mondays, over weekends etc)? ","INPUT",null,{"$f":"HYPERLINK(\"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf\",\"European Medicines Agency : Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products\")","v":"European Medicines Agency : Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products"},null,{"$f":"IF(E53=\"no\",M53,L53)","v":0},null,"INPUT",null,"NA"]
[null,"Device",null,null,"INPUT",null,null,"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf",{"$f":"IF(E54=\"no\",M53,L53)","v":0}]

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["Participant Engagement",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If Other","If No"]
[7.01,"IP","Does your site use Participant Orientation and General Information","Do you provide participant orientation to the study? ","INPUT","This includes a tour of all areas to be accessed by the participant (including location of emergency call button).  Disabled access should be available.  ","NA",null,{"$f":"IF(E4=\"NO\",M4,L5)","v":0},null,"Any Phase",null,"For efficient running of the study please give participants an orientation as per your orientation checklist."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E5=\"NO\",M4,L5)","v":0}]
[{"$f":"A4+0.01","v":7.02},"IP",null,"Do you have patient/participant information available covering ;\n- generic clinical trial information\n- disease indication, and\n- support groups if applicable?","INPUT","As per the PICF and other institutional guidelines.","NA",null,{"$f":"IF(E6=\"NO\",M6,L7)","v":0},null,"Any Phase",null,"Consider patient reluctance to continue if not adequately educated on the requirements of the study."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E7=\"NO\",M6,L7)","v":0}]
[{"$f":"A6+0.01","v":7.0299999999999994},"IP","Does your site have an SOP or procedure outlining the following :","Participant provision of all applicable participant facing material, including contact information, any applicable participant training, study documents?","INPUT","As per the PICF and other institutional guidelines.","NA",null,{"$f":"IF(E8=\"NO\",M8,L9)","v":0},null,"Any Phase",null,"Participants may be reluctant to continue if not adequately educated on the requirements of the study."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E9=\"NO\",M8,L9)","v":0}]
[{"$f":"A8+0.01","v":7.0399999999999991},"IP",null,"Privacy and confidentiality in relation to participants and their personal/medical information?","INPUT","As per the PICF and other institutional guidelines.",{"$f":"HYPERLINK(\"https://www.oaic.gov.au/\",\"Office of the Australian Information Commissioner website\")","v":"Office of the Australian Information Commissioner website"},null,{"$f":"IF(E10=\"NO\",M10,L11)","v":0},null,"Any Phase",null,"Clinical trial cannot proceed without adherence to these guidelines."]
[null,"Device",null,null,"INPUT",null,null,"https://www.oaic.gov.au/",{"$f":"IF(E11=\"NO\",M10,L11)","v":0}]
[{"$f":"A10+0.01","v":7.0499999999999989},"IP",null,"Participant communication; commencing at screening, through active participation and following the end of study participation, and should consider the provision of consent for communication with a participants healthcare professional?","INPUT","As per the PICF and other institutional guidelines.  Can you provide a really clear outline of the study.",{"$f":"HYPERLINK(\"https://chf.org.au/sites/default/files/consumer_guide_clinical_trials_130621.pdf\",\"Consumer Health Forum of Australia : Consumer Guide to Clinical Trials\")","v":"Consumer Health Forum of Australia : Consumer Guide to Clinical Trials"},null,{"$f":"IF(E12=\"NO\",M12,L13)","v":0},null,"Any Phase",null,"Clear communication is vital for the conduct of the trial."]
[null,"Device",null,null,"INPUT",null,null,"https://chf.org.au/sites/default/files/consumer_guide_clinical_trials_130621.pdf",{"$f":"IF(E13=\"NO\",M12,L13)","v":0}]
[{"$f":"A12+0.01","v":7.0599999999999987},"IP",null,"Site specific Participant emergency guidelines including provision of alert card and participant education for reporting adverse events (AE), and presentation in the event of serious adverse medical event (SAE)?","INPUT","As per the PICF and other institutional guidelines. Many sponsored studies will provide a participant card (alert card), if not study specific the site should have a generic alert card to provide to clinical trial participants.","NA",null,{"$f":"IF(E14=\"NO\",M14,L15)","v":0},null,"Any Phase",null,"Do not proceed with the trial until provided."]
[null,"Device",null,null,"INPUT",null,null,"n/a",{"$f":"IF(E15=\"NO\",M14,L15)","v":0}]
[{"$f":"A14+0.01","v":7.0699999999999985},"IP",null,"Expectations of Participants (including behaviour) e.g. “House Rules”?","INPUT","As per the PICF and other institutional guidelines.","CT:IQ has developed a House Rules editible template that you can adapt to suit your requirements.  Check with your institution if formal HREC/governance approval is required. ","CT:IQ has developed a House Rules editible template that you can adapt to suit your requirements.  Check with your institution if formal HREC/governance approval is required. ",{"$f":"IF(E16=\"NO\",M16,L17)","v":0},null,"Any Phase",null,"Expectation is for the participant to agree to the House Rules prior to commencement of the trial."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E17=\"NO\",M16,L17)","v":0}]
[{"$f":"A16+0.01","v":7.0799999999999983},"IP",null,"Participant Reimbursement guidelines and a process for reimbursement?","INPUT","As per the PICF and other institutional guidelines.","NA",null,{"$f":"IF(E18=\"NO\",M18,L19)","v":0},null,"Any Phase",null,"It is important to discuss and agree to the financial conditions relating to the trial."]
[null,"Device",null,null,"INPUT",null,null,null,{"$f":"IF(E19=\"NO\",M18,L19)","v":0}]
[{"$f":"A18+0.01","v":7.0899999999999981},"IP",null,"Management of complaints?","INPUT","As per the PICF and other institutional guidelines.",{"$f":"HYPERLINK(\"https://www.humanrights.gov.au/complaints\",\"This is the national complaints process. Some states and territories have separate processes for health complaints.\")","v":"This is the national complaints process. Some states and territories have separate processes for health complaints."},"https://www.humanrights.gov.au/complaints",{"$f":"IF(E20=\"NO\",M20,L20)","v":0},null,"Any Phase",null,"Access to the complaints processes relating to each state and territory should be available to participants during the clinical trials process."]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.hccc.nsw.gov.au/Complaints/default.aspx\",\"New South Wales Complaints Process\")","v":"New South Wales Complaints Process"},"https://www.hccc.nsw.gov.au/Complaints/default.aspx"]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://en.wikipedia.org/wiki/Health_Care_Complaints_Commission\",\"General Information on Health Care Complaints Processes\")","v":"General Information on Health Care Complaints Processes"},"https://en.wikipedia.org/wiki/Health_Care_Complaints_Commission"]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.ahpra.gov.au/Notifications/Further-information/Health-complaints-organisations.aspx\",\"For Complaints against individual Health Professionals.\")","v":"For Complaints against individual Health Professionals."},"https://www.ahpra.gov.au/Notifications/Further-information/Health-complaints-organisations.aspx"]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.oho.qld.gov.au/make-a-complaint/\",\"Queensland Ombudsman for all Health Care Complaints\")","v":"Queensland Ombudsman for all Health Care Complaints"},"https://www.oho.qld.gov.au/make-a-complaint/"]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://hrc.act.gov.au/health/\",\"Australian Capital Territory Health Care Complaints\")","v":"Australian Capital Territory Health Care Complaints"}]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.hcscc.sa.gov.au/making-a-complaint/\",\"South Australia Health Care Complaints Process\")","v":"South Australia Health Care Complaints Process"}]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.healthcomplaints.tas.gov.au/\",\"Tasmanian Health Care Complaints Process\")","v":"Tasmanian Health Care Complaints Process"}]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.hcscc.nt.gov.au/\",\"Northern Territory Health Care Complaints Process\")","v":"Northern Territory Health Care Complaints Process"}]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://hcc.vic.gov.au/\",\"Victorian Health Care Complaints Process\")","v":"Victorian Health Care Complaints Process"}]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.hadsco.wa.gov.au/home/\",\"Western Australia Health Care Complaints Process\")","v":"Western Australia Health Care Complaints Process"}]
[null,"Device",null,null,"INPUT",null,{"$f":"HYPERLINK(\"https://www.humanrights.gov.au/complaints\",\"This is the national complaints process. Some states and territories have separate processes for health complaints.\")","v":"This is the national complaints process. Some states and territories have separate processes for health complaints."},null,{"$f":"IF(E31=\"NO\",M20,L20)","v":0}]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://www.hccc.nsw.gov.au/Complaints/default.aspx\",\"New South Wales Complaints Process\")","v":"New South Wales Complaints Process"}]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://en.wikipedia.org/wiki/Health_Care_Complaints_Commission\",\"General Information on Health Care Complaints Processes\")","v":"General Information on Health Care Complaints Processes"}]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://www.ahpra.gov.au/Notifications/Further-information/Health-complaints-organisations.aspx\",\"For Complaints against individual Health Professionals.\")","v":"For Complaints against individual Health Professionals."}]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://www.oho.qld.gov.au/make-a-complaint/\",\"Queensland Ombudsman for all Health Care Complaints\")","v":"Queensland Ombudsman for all Health Care Complaints"}]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://hrc.act.gov.au/health/\",\"Australian Capital Territory Health Care Complaints\")","v":"Australian Capital Territory Health Care Complaints"},"https://hrc.act.gov.au/health/"]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://www.hcscc.sa.gov.au/making-a-complaint/\",\"South Australia Health Care Complaints Process\")","v":"South Australia Health Care Complaints Process"},"https://www.hcscc.sa.gov.au/making-a-complaint/"]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://www.healthcomplaints.tas.gov.au/\",\"Tasmanian Health Care Complaints Process\")","v":"Tasmanian Health Care Complaints Process"},"https://www.healthcomplaints.tas.gov.au/"]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://www.hcscc.nt.gov.au/\",\"Northern Territory Health Care Complaints Process\")","v":"Northern Territory Health Care Complaints Process"},"https://www.hcscc.nt.gov.au/"]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://hcc.vic.gov.au/\",\"Victorian Health Care Complaints Process\")","v":"Victorian Health Care Complaints Process"},"https://hcc.vic.gov.au/"]
[null,"Device",null,null,null,null,{"$f":"HYPERLINK(\"https://www.hadsco.wa.gov.au/home/\",\"Western Australia Health Care Complaints Process\")","v":"Western Australia Health Care Complaints Process"},"https://www.hadsco.wa.gov.au/home/"]

{"sheet":"8.Pharmacy","index":8,"n_rows":11,"n_cols":13,"rows_kept":11,"cut":false,"hidden":false,"merged":[[3,11,4,11],[3,12,4,12],[5,2,9,2],[0,9,1,9],[0,0,1,8],[3,0,4,0],[3,2,4,2],[3,3,4,3],[3,4,4,4],[3,8,4,8],[3,9,4,9],[3,5,4,5]]}
["Pharmacy",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If Other","If No"]
[8.01,"IP","Does your pharmacy support and have the capability of doing what is required for the study","Is you Pharmacist involved in reviewing the pharmacy manual and protocol in the feasibility stage?","INPUT","These are core activities for clinical trial pharmacies. Can an alternative pharmacy vendor be utilized if on-site pharmacy facilities are not available?","SHPA Standards of Practice for Pharmacy Investigational Drugs Services DRAFT June 2019",null,{"$f":"IF(E4=\"no\",M4,L5)","v":0},null,null,null,"NA"]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://cdn.ymaws.com/www.tmn.ac.uk/resource/collection/EB6F8F90-FE1B-4224-92E2-0E55AEA55BFB/2011-08-19_Pharmacy_GCP_Checklist_(CHCUK_McCully)[1].pdf\",\"Pharmacy GCP Compliance Checklist\")","v":"Pharmacy GCP Compliance Checklist"},"https://cdn.ymaws.com/www.tmn.ac.uk/resource/collection/EB6F8F90-FE1B-4224-92E2-0E55AEA55BFB/2011-08-19_Pharmacy_GCP_Checklist_(CHCUK_McCully)[1].pdf",null,null,"Any Phase"]
[{"$f":"A4+0.01","v":8.02},"IP","Does your pharmacy have the following capability of :","Attending to IMP ordering, delivery, packaging, labelling,  storage, dispensing, handling, return, destruction, quarantine procedure, double blind and rescue medicine and corresponding Standard Operating Procedures (SOP) for all procedures?","INPUT","Adequate resources are essential.",{"$f":"HYPERLINK(\"https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Hospital%20Pharmacy%20Hub/professional-guidance--n-pharmacy-services-for-clinical-trials-141013.pdf\",\"National Pharmacy Clinical Trials Group : Professional guidance on Pharmacy services for clinical trials\")","v":"National Pharmacy Clinical Trials Group : Professional guidance on Pharmacy services for clinical trials"},"https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Hospital%20Pharmacy%20Hub/professional-guidance--n-pharmacy-services-for-clinical-trials-141013.pdf",{"$f":"IF(E6=\"NO\",M6,L6)","v":0},null,"Any Phase",null,"Requirement for studies using investigational products."]
[{"$f":"A6+0.01","v":8.0299999999999994},"IP",null,"Second check when dispensing the IMP (technician and pharmacist, or pharmacist and pharmacist)?","INPUT","Please refer to your state's pharmacy guidance and legal obligations when handling, dispensing and supplying drugs.",{"$f":"HYPERLINK(\"https://www.shpa.org.au/standards-of-practice\",\"Pharmacy Standards of Practise\")","v":"Pharmacy Standards of Practise"},"https://www.shpa.org.au/standards-of-practice",0,null,"Any Phase",null,"NA"]
[8.0399999999999991,"IP",null,"Protocol trained pharmacist accessible on dosing days?","INPUT",null,"NA","n/a",0,null,"Any Phase",null,"NA"]
[8.0499999999999989,"IP",null,"Area to accommodate monitoring or auditing visit?","INPUT","Typically sponsor requirement to perform accountability.","NA","n/a",0,null,"Any Phase",null,"NA"]
[8.0599999999999987,"IP",null,"After hours on-call pharmacist (not necessarily clinical trials pharmacist)?","INPUT",null,"NA","n/a",0,null,"Early Phase",null,"NA"]
[8.0699999999999985,"IP","Does your site have appropriate spill management for GMOs","For Genetically Modified Organisms (GMO) trials, required procedures, equipment and SOPs for product handing, as outlined by the Office of the Gene Technology Regulator (OGTR)?","INPUT","The use of GMO's and biologics in clinical trials is an emerging treatment field of research.  Sites must consider contents of spill kits, working withiin the DNIR license, specific training requried for nursing staff and the site requirement of a PC2 lab.",{"$f":"HYPERLINK(\"http://www.ogtr.gov.au\",\"Office of the Gene Technology Regulator\")","v":"Office of the Gene Technology Regulator"},"(http://www.ogtr.gov.au).",0,null,"Any Phase",null,"Requirement for studies using GMOs."]

{"sheet":"9.Lab","index":9,"n_rows":19,"n_cols":13,"rows_kept":19,"cut":false,"hidden":false,"merged":[[10,3,11,3],[10,2,13,2],[10,12,11,12],[10,0,11,0],[10,8,11,8],[10,5,11,5],[0,9,1,9],[0,0,1,8],[5,2,9,2],[3,4,4,4],[3,3,4,3],[3,2,4,2],[3,0,4,0],[3,9,4,9],[5,9,6,9],[5,3,6,3],[5,0,6,0],[3,8,4,8],[5,8,6,8],[5,4,6,4],[3,5,4,5],[5,5,6,5],[14,0,15,0],[14,2,15,2],[17,0,18,0],[16,2,18,2],[17,11,18,11],[17,10,18,10],[17,9,18,9],[14,9,15,9],[14,10,15,10],[17,3,18,3],[14,3,15,3],[14,4,15,4],[17,8,18,8],[14,11,15,11],[14,13,15,13],[17,12,18,12],[10,9,11,9],[17,4,18,4],[17,5,18,5],[14,12,15,12],[14,5,15,5],[14,8,15,8],[10,4,11,4]]}
[" Laboratory Requirements",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If Other","If No"]
[9.01,"IP","Will your site be responsible for processing biological samples?","Will your site prepare or process biological samples for analysis at either a local or central laboratory?","INPUT","National Association of Testing Authority (NATA) sets out the standards that bioanalytical facilities should adhere to. Sponsor typically determines laboratory selected.",{"$f":"HYPERLINK(\"https://www.safeworkaustralia.gov.au/ppe \",\"Safe Work Australia : Personal Protective Equipment\n\n\")","v":"Safe Work Australia : Personal Protective Equipment\n\n"},null,{"$f":"IF(E4=\"NO\",M5,L5)","v":0}]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.nata.com.au/phocadownload/gen-nata-docs/About-NATA-and-accreditation.pdf\",\"About NATA and accreditation\")","v":"About NATA and accreditation"},"https://www.nata.com.au/phocadownload/gen-nata-docs/About-NATA-and-accreditation.pdf",null,null,"Any Phase",null,"The study sponsor should approve non-NATA laboratory facilities.  For some exploratory endpoints this may be acceptable. "]
[{"$f":"A4+0.01","v":9.02},"IP","Does your Laboratory (lab) utilize the following safe lab practices?","Does your site have appropriate equipment for the procedures you perform;\n- Personal protective equipment (PPE)\n- Spill Kits, eye wash or shower\n- Centrifuges, vortex, micropipette etc\n- Biohazard/biological waste bins?","INPUT","Hazardous material must be handled and disposed of in accordance with national and state requirements.",{"$f":"HYPERLINK(\"https://www.nhmrc.gov.au/sites/default/files/documents/attachments/19269%20NHMRC%20-%20Infection%20Control%20Guidelines-accessible.pdf\",\"NHMRC Australian Guidelines for the Prevention and Control of Infection in Healthcare 2019\")","v":"NHMRC Australian Guidelines for the Prevention and Control of Infection in Healthcare 2019"},null,{"$f":"IF(E6=\"no\",M7,L7)","v":0}]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.legislation.gov.au/Details/C2017C00194\",\"Hazardous Waste (Regulation of Exports and Imports) Act 1989\")","v":"Hazardous Waste (Regulation of Exports and Imports) Act 1989"},"https://www.legislation.gov.au/Details/C2017C00194",null,null,"Any Phase",null,"Potential for environmental and personnel hazardous exposure."]
[{"$f":"A6+0.01","v":9.0299999999999994},"IP",null,"Does your site have a  documented procedure for:\n- Study specific sample preparation training\n- Sterilization and disinfection process for shipping and return of goods?\n- Procedure for accidental exposure to biological material?\n- Procedure for management of a biological or chemical spill?","INPUT","Laboratory personnel handling potentially hazardous material require procedures to ensure safe sample handling and spill or exposure management processes.",{"$f":"HYPERLINK(\"https://www.safeworkaustralia.gov.au/system/files/documents/1908/code_of_practice_-_first_aid_in_the_workplace_0_0.pdf\",\"Code of Practice: First aid in the workplace (July 2019)\")","v":"Code of Practice: First aid in the workplace (July 2019)"},"https://www.safeworkaustralia.gov.au/system/files/documents/1908/code_of_practice_-_first_aid_in_the_workplace_0_0.pdf",{"$f":"IF(E8=\"no\",M8,L8)","v":0},null,"Any Phase",null,"Potential for failure to provide basic first aid in a hazardous environment."]
[{"$f":"A8+0.01","v":9.0399999999999991},"IP",null,"International Air Transport Association (IATA) certified Dangerous Goods Training for handling and shipping 'dangerous good like biological samples'?","INPUT","Part 92 of Civil Aviation Safety Regulations (CASR) prescribes the minimum safety requirements for the consignment and carriage of dangerous goods by air.",{"$f":"HYPERLINK(\"https://www.casa.gov.au/safety-management/dangerous-goods/dangerous-goods-services/organisations-offering-shippers-courses-infectious-substances-diagnostic-specimens-and-dry-ice\",\"CASA training link\")","v":"CASA training link"},"https://www.casa.gov.au/safety-management/dangerous-goods/dangerous-goods-services/organisations-offering-shippers-courses-infectious-substances-diagnostic-specimens-and-dry-ice",0,null,"Any Phase",null,"Failure to meet legislation requirements."]
[9.0499999999999989,"IP",null,"Are Materials Safety Data Sheets (MSDS) and Chemical Register available for all chemicals used in the laboratory?","INPUT","A hazardous chemicals register is required under the Work Health and Safety Regulations to be prepared and kept up-to-date","Work Health and Safety Regulations 2011","https://www.legislation.gov.au/Details/F2019C00050",0,null,"Any Phase",null,"Failure to meet legislation requirements."]
[{"$f":"A10+0.01","v":9.0599999999999987},"IP","Does your site have the following equipment available on site?","Is a biohazard or laminar flow unit available on site? Biohazard waste bin available?","INPUT","Requirement for the use and compounding of certain hazardous chemicals.",{"$f":"HYPERLINK(\"https://www.legislation.gov.au/Details/C2017C00194\",\"Hazardous Waste (Regulation of Exports and Imports) Act 1989\")","v":"Hazardous Waste (Regulation of Exports and Imports) Act 1989"},null,{"$f":"IF(E11=\"no\",M11,L12)","v":0},null,null,null,"This may restrict the types of samples or processing that can be completed. "]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.google.com/search?q=australian+standard+biological+safety+cabinet&rlz=1C1GCEU_en-GBAU821AU821&oq=australian+standards+biological+&aqs=chrome.1.69i57j0.15478j0j7&sourceid=chrome&ie=UTF-8\",\"Australian/New Zealand Standard Biological Safety Cabinets - Installation and use\")","v":"Australian/New Zealand Standard Biological Safety Cabinets - Installation and use"},"https://www.google.com/search?q=australian+standard+biological+safety+cabinet&rlz=1C1GCEU_en-GBAU821AU821&oq=australian+standards+biological+&aqs=chrome.1.69i57j0.15478j0j7&sourceid=chrome&ie=UTF-8",null,null,"Any Phase"]
[{"$f":"A11+0.01","v":9.0699999999999985},"IP",null,"Does the site have access to dry ice for shipping samples?","INPUT","Many samples need to be shipped on dry ice.","NA","n/a",{"$f":"IF(E13=\"no\",M13,L13)","v":0},null,"Any Phase",null,"In some cases this may be provided by the courier company, but it is helpful to know where it can be sourced."]
[{"$f":"A13+0.01","v":9.0799999999999983},"IP",null,"Are there procedures and equipment available to manage biological and chemical spills?","INPUT","Sites should have a written procedure to minimise risk of exposure to blood and chemical spills.",{"$f":"HYPERLINK(\"https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1\",\"WHO Biosafety Manual, Third Edition\")","v":"WHO Biosafety Manual, Third Edition"},"https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1",{"$f":"IF(E14=\"no\",M14,L14)","v":0},null,"Any Phase",null,"Potential for personnel exposure to biological hazards. Good microbial technique (GMT) should be utilised at all times. "]
[{"$f":"A14+0.01","v":9.0899999999999981},"IP","Are the following sample handling procedures available on site?","Does the site have a process for the collection, management and handling of biological samples? Including biological sample handling logs?","INPUT","Sites should have a written procedure (SOP) detailing their sample management processes. ",{"$f":"HYPERLINK(\"https://www.health.qld.gov.au/__data/assets/pdf_file/0020/151067/gcp_sop12.pdf \",\"Example of SOP from Qld Health for biological handling and transport\")","v":"Example of SOP from Qld Health for biological handling and transport"},"https://www.health.qld.gov.au/__data/assets/pdf_file/0020/151067/gcp_sop12.pdf\n",{"$f":"IF(E15=\"no\",M15,L15)","v":0},null,"Any Phase",null,"Potential non-compliance with Good Clinical Practice (GCP). "]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.mcri.edu.au/sites/default/files/media/sop_sample_collection_handling_transport_2018-12-05.pdf\",\"Example of SOP from MCRI for biological handling and transport\")","v":"Example of SOP from MCRI for biological handling and transport"},"https://www.mcri.edu.au/sites/default/files/media/sop_sample_collection_handling_transport_2018-12-05.pdf"]
[{"$f":"A15+0.01","v":9.0999999999999979},"IP","Are GMO products/specimens going to be processed on site?","Does the site have an Institutional Biosafety Committee (IBC) able to evaluate the use of Genetically Modified Organisms (GMOs) at site?","INPUT","Organisations dealing with GMOs must be accredited and must have an Institutional Biosafety Committee (IBC), or access to an IBC, which reviews research applications and monitors certified facilities.",{"$f":"HYPERLINK(\"https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1\",\"WHO Biosafety Manual, Third Edition\")","v":"WHO Biosafety Manual, Third Edition"},"https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1",{"$f":"IF(E17=\"no\",M17,L17)","v":0},null,"Any Phase",null,"GMO studies may not be completed at the site."]
[{"$f":"A17+0.01","v":9.1099999999999977},"IP",null,"Does the processing laboratory have the appropriate level of containment to manage samples within the licensing conditions? ","INPUT","The Office of the Gene Technology Regulator (OGTR) reviews GMO applications and issues licenses detailing the level of precautions to be taken; e.g.: PC1, PC2 or higher.",{"$f":"HYPERLINK(\"http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/FacilTypesv1-2-htm \",\"Explanatory Information - Guide to Physical Containment Levels and Facility Types\n\n\")","v":"Explanatory Information - Guide to Physical Containment Levels and Facility Types\n\n"},"http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/FacilTypesv1-2-htm\n",{"$f":"IF(E18=\"no\",M18,L18)","v":0},null,"Any Phase",null,"Required for sites processing samples using GMO's. "]
[null,"IP",null,null,null,null,{"$f":"HYPERLINK(\"https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf\",\"WHO Biosafety Manual, Third Edition\")","v":"WHO Biosafety Manual, Third Edition"},"https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf"]

{"sheet":"10.CTRA","index":10,"n_rows":17,"n_cols":13,"rows_kept":17,"cut":false,"hidden":false,"merged":[[7,0,8,0],[7,3,8,3],[7,6,8,6],[9,9,10,9],[11,0,12,0],[11,3,12,3],[11,6,12,6],[7,5,8,5],[11,5,12,5],[9,5,10,5],[9,13,10,13],[3,9,4,9],[3,11,4,11],[3,12,4,12],[3,13,4,13],[9,10,10,10],[7,9,8,9],[7,10,8,10],[7,11,8,11],[7,12,8,12],[7,13,8,13],[3,10,4,10],[9,12,10,12],[9,11,10,11],[11,13,12,13],[13,13,14,13],[13,12,14,12],[13,11,14,11],[13,10,14,10],[11,10,12,10],[11,11,12,11],[11,12,12,12],[0,9,1,9],[0,0,1,8],[13,0,14,0],[15,0,16,0],[15,3,16,3],[13,9,14,9],[13,6,14,6],[13,3,14,3],[15,9,16,9],[11,9,12,9],[9,3,10,3],[9,0,10,0],[3,0,4,0],[3,2,12,2],[3,3,4,3],[3,5,4,5],[15,13,16,13],[15,6,16,6],[15,10,16,10],[15,11,16,11],[13,2,16,2],[13,5,14,5],[15,5,16,5],[15,12,16,12]]}
["CTRA  (Clinical Trial Research Agreement)",null,null,null,null,null,null,null,null,"HOME"]
[]
["Qu No","Select Trial Type Filter","Question Classification","Question \n(click on actual question for the rationale/description)","Answer (add response)","Rationale/Description","Resource Links","Resource Link","What does it mean if No?\n(This will only populate if No selected in Answer)","Site Comments\n(Add as required)","Phase Specific","If Other","If No"]
[10.01,"IP","Does your site utilize standard templates","Standard templates for clinical research agreements and indemnities?","INPUT","A written agreement clarifying the obligations, responsibilities and rights of the parties involved in the trial is a requirement for the governance of the trial. Sponsor /CRO must be an Australian entity. Standard templates reduce the necessity for repetitive legal review.","See SOP templates","https://www.medicalresearch.nsw.gov.au/clinical-trial-toolkit/",{"$f":"IF(E4=\"no\",M4,L4)","v":0},null,"Any Phase",null,"Consider using standard templates."]
[null,"Device",null,null,"INPUT",null,{"$f":"HYPERLINK(\"https://www.ihpa.gov.au/sites/default/files/publications/determination_of_standard_costs_associated_with_clinical_trials_in_australia.pdf\",\"Guidance for standard costs associated with Clinical Trials in Australia\")","v":"Guidance for standard costs associated with Clinical Trials in Australia"},"https://www.ihpa.gov.au/sites/default/files/publications/determination_of_standard_costs_associated_with_clinical_trials_in_australia.pdf",{"$f":"IF(E5=\"no\",M4,L4)","v":0}]
[{"$f":"A4+0.01","v":10.02},"IP",null,"Medicines Australia agreements for Clinical Trials of Investigational Products? ","INPUT","Used when a pharmaceutical company is sponsoring a clinical trial.",{"$f":"HYPERLINK(\"https://medicinesaustralia.com.au/policy/clinical-trials/clinical-trials-research-agreements/\",\"Medicines Australia agreements for Clinical Trials of Investigational Products\")","v":"Medicines Australia agreements for Clinical Trials of Investigational Products"},"https://medicinesaustralia.com.au/policy/clinical-trials/clinical-trials-research-agreements/",{"$f":"IF(E6=\"NO\",M6,L6)","v":0},null,"Any Phase",null,"Consider using the Medicines Australia agreements."]
[{"$f":"A6+0.01","v":10.029999999999999},"Device",null,"Medical Technology Association of Australia (MTAA) for Clinical Investigations and Devices?","INPUT","Used when a medical device company is sponsoring a clinical trial.",{"$f":"HYPERLINK(\"https://www.mtaa.org.au/clinical-investigations   \",\"Medical Technology Association of Australia (MTAA) for Clinical Investigations and Devices\")","v":"Medical Technology Association of Australia (MTAA) for Clinical Investigations and Devices"},"https://www.mtaa.org.au/clinical-investigations   ",{"$f":"IF(E7=\"NO\",M7,L7)","v":0},null,"Any Phase",null,"Refer to MTAA website."]
[{"$f":"A7+0.01","v":10.039999999999999},"IP",null,"Sponsor Specific Clauses for agreements with Public Health Institutions within NSW, QLD, VIC, SA and TAS Health Departments through the South Eastern Border States (SEBS Committee)?","INPUT","The Clinical Trial Research Agreement (CTRA) is designed to allow inclusion of sponsor specific clauses through the nominated Schedule; Schedule 4 for Standard Collaborative or Cooperative Research Groups CTRA and Schedule 7 for other CTRAs. ",{"$f":"HYPERLINK(\"https://medicinesaustralia.com.au/policy/clinical-trials/clinical-trials-research-agreements/\",\"Medicines Australia research agreements\")","v":"Medicines Australia research agreements"},null,{"$f":"IF(E8=\"NO\",M8,L8)","v":0},null,"Any Phase",null,"Relevant to public health institutions. Please refer to your research office for additional guidance."]
[null,"Device",null,null,"INPUT",null,null,"https://medicinesaustralia.com.au/policy/clinical-trials/clinical-trials-research-agreements/",{"$f":"IF(E9=\"NO\",M8,L8)","v":0}]
[{"$f":"A8+0.01","v":10.049999999999999},"IP",null,"Is your site aware that all commercially sponsored research must include the Medicines Australia Standard Form of Indemnity or MTAA  Standard Form of Indemnity and that all commercially sponsored research must provide evidence of appropriate insurance?","INPUT","Indemnity is a contractual term to protect parties from specified actions, losses or claims. ",{"$f":"HYPERLINK(\"https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/\",\"Medicines Australia Form of Indemnity\")","v":"Medicines Australia Form of Indemnity"},"https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/",{"$f":"IF(E10=\"NO\",M10,L10)","v":0},null,"Any Phase",null,"This is required."]
[null,"Device",null,null,"INPUT",null,{"$f":"HYPERLINK(\"https://www.mtaa.org.au/sites/default/files/uploaded-content/website-content/mtaa-standard-form-of-indemnity-for-a-clinical-investigation-%28version-1---8-april-2010%29.pdf\",\"\nMTAA Standard Form of Indemnity \n\n\")","v":"\nMTAA Standard Form of Indemnity \n\n"},"https://www.mtaa.org.au/sites/default/files/uploaded-content/website-content/mtaa-standard-form-of-indemnity-for-a-clinical-investigation-%28version-1---8-april-2010%29.pdf",{"$f":"IF(E11=\"NO\",M10,L10)","v":0}]
[{"$f":"A10+0.01","v":10.059999999999999},"IP",null,"Service Level Agreements with third party vendors?","INPUT","Evidence of current insurance must be appropriate for the type of research.","NA",null,{"$f":"IF(E12=\"NO\",M12,L12)","v":0},null,"Any Phase",null,"This is required."]
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[{"$f":"'2.Safety'!A8","v":2.0299999999999994},{"$f":"'2.Safety'!$C$4","v":"Does your site have access to the following safety measures?"},{"$f":"'2.Safety'!D8","v":"Advanced Life Support (Crash cart), oxygen, patient/participant call bells, staff emergency situation procedure and adequately trained staff?"},{"$f":"'2.Safety'!E8","v":"INPUT"},{"$f":"'2.Safety'!F8","v":"Per EMA guidelines, trials should take place under close supervision during and after dosing. Units need immediate access to appropriately qualified staff for resuscitating and stabilising individuals in an acute emergency. Practiced procedure should also be in place for the transfer of patients to an emergency or ICU department.\n"},{"$f":"'2.Safety'!I8","v":0},{"$f":"'2.Safety'!J8","v":0}]
[null,null,null,{"$f":"'2.Safety'!E10","v":"INPUT"},null,{"$f":"'2.Safety'!I11","v":0}]
[{"$f":"'2.Safety'!A12","v":2.0399999999999991},{"$f":"'2.Safety'!$C$4","v":"Does your site have access to the following safety measures?"},{"$f":"'2.Safety'!D12","v":"An agreement with a hospital for transferring patients requiring emergency interventions?"},{"$f":"'2.Safety'!E12","v":"INPUT"},{"$f":"'2.Safety'!F12","v":"Per EMA guidelines, procedures should be established between the clinical research unit and nearby emergency or ICU department for the transfer of patients which require emergency interventions."},{"$f":"'2.Safety'!I12","v":0},{"$f":"'2.Safety'!J12","v":0}]
[null,null,null,{"$f":"'2.Safety'!E13","v":"INPUT"},null,{"$f":"'2.Safety'!I13","v":0}]
[{"$f":"'2.Safety'!A14","v":2.0499999999999989},{"$f":"'2.Safety'!$C$4","v":"Does your site have access to the following safety measures?"},{"$f":"'2.Safety'!D14","v":"Procedure for the management of adverse reactions?"},{"$f":"'2.Safety'!E14","v":"INPUT"},{"$f":"'2.Safety'!F14","v":"Staff should be trained in how to identify and respond to adverse reactions either secondary to a treatment of procedure.  Training and planning should be considered on a study level. For any double blind study, clear unblinding instructions are required in the protocol. "},{"$f":"'2.Safety'!I14","v":0},{"$f":"'2.Safety'!J14","v":0}]
[null,null,null,{"$f":"'2.Safety'!E15","v":"INPUT"},null,{"$f":"'2.Safety'!I15","v":0}]
[{"$f":"'2.Safety'!A16","v":2.0599999999999987},{"$f":"'2.Safety'!$C$16","v":"Is your site proficient in clinical safety data management?"},{"$f":"'2.Safety'!D16","v":"Do you have procedures for the identification and an awareness of which of the following events require reporting, and in what timeframe?\n- An adverse event or reaction, \n- Unexpected adverse event or reaction, \n- Serious adverse event or reaction, \n- Assessment of the expectedness of an adverse event or reaction? \n- SSI's (significant safety issues)?\n- USADE's (unanticipated serious adverse device effects)?\n- USM's (urgent safety measures)?"},{"$f":"'2.Safety'!E16","v":"INPUT"},{"$f":"'2.Safety'!F16","v":"Site equipped to identify and respond to safety events and reactions."},{"$f":"'2.Safety'!I16","v":0},{"$f":"'2.Safety'!J16","v":0},null,{"$f":"'2.Safety'!I10:I11","v":{"$error":"#VALUE!"}}]
[null,null,null,{"$f":"'2.Safety'!E18","v":"INPUT"},null,{"$f":"'2.Safety'!I17","v":0}]
[{"$f":"'2.Safety'!A20","v":2.0699999999999985},{"$f":"'2.Safety'!$C$20","v":"Is your site aware of the reporting requirements for the following?"},{"$f":"'2.Safety'!D20","v":"Reporting of serious breaches of GCP or the protocol?"},{"$f":"'2.Safety'!E20","v":"INPUT"},{"$f":"'2.Safety'!F20","v":"Staff should be trained in how to identify GCP and protocol non-compliance, including how to respond and an overview of reporting pathways."},{"$f":"'2.Safety'!I18","v":0},{"$f":"'2.Safety'!J20","v":0}]
[null,{"$f":"'2.Safety'!$C$20","v":"Is your site aware of the reporting requirements for the following?"},{"$f":"'2.Safety'!D21","v":"Reporting of serious breaches of ISO1555 or the protocol?"},{"$f":"'2.Safety'!E21","v":"INPUT"},{"$f":"'2.Safety'!F21","v":"Staff should be trained in how to identify non-compliance with ISO 14155 and the protocol, including how to respond and an overview of reporting pathways."},{"$f":"'2.Safety'!I19","v":0},{"$f":"'2.Safety'!J21","v":0}]
[{"$f":"'3.Staff'!A4","v":3.01},{"$f":"'3.Staff'!$C$4","v":"Does your site comply with the following Safe Workplace Practices"},{"$f":"'3.Staff'!D4","v":"Your state’s safe workplace practises?"},{"$f":"'3.Staff'!E4","v":"INPUT"},{"$f":"'3.Staff'!F4","v":"This is a legislative requirement."},{"$f":"'3.Staff'!I4","v":0},{"$f":"'3.Staff'!J4","v":0}]
[null,null,null,{"$f":"'3.Staff'!E5","v":"INPUT"},null,{"$f":"'3.Staff'!I5","v":0}]
[{"$f":"'3.Staff'!A6","v":3.0199999999999996},{"$f":"'3.Staff'!$C$4","v":"Does your site comply with the following Safe Workplace Practices"},{"$f":"'3.Staff'!D6","v":"Your institutions safe workplace guidance and any specific work procedures?"},{"$f":"'3.Staff'!E6","v":"INPUT"},{"$f":"'3.Staff'!F6","v":"Refer to your institution's policies and procedures."},{"$f":"'3.Staff'!I6","v":0},{"$f":"'3.Staff'!J6","v":0}]
[null,null,null,{"$f":"'3.Staff'!E7","v":"INPUT"},null,{"$f":"'3.Staff'!I7","v":0}]
[{"$f":"'3.Staff'!A8","v":3.0299999999999994},{"$f":"'3.Staff'!$C$8","v":"Does your site have an adequate and appropriate staffing (Education and Experience): \n"},{"$f":"'3.Staff'!D8","v":"Does your site have a Site Trial Manager/Coordinator who is dedicated point of contact for sponsor/CRO?"},{"$f":"'3.Staff'!E8","v":"INPUT"},{"$f":"'3.Staff'!F8","v":"This may be dependent on study type and volume of participants."},{"$f":"'3.Staff'!I8","v":0},{"$f":"'3.Staff'!J8","v":0}]
[null,null,null,{"$f":"'3.Staff'!E9","v":"INPUT"},null,{"$f":"'3.Staff'!I9","v":0}]
[{"$f":"'3.Staff'!A10","v":3.0399999999999991},{"$f":"'3.Staff'!$C$8","v":"Does your site have an adequate and appropriate staffing (Education and Experience): \n"},{"$f":"'3.Staff'!D10","v":"Does your staffing matrix consider;\n- Timely PI/coordinator response to safety events\n- Data entry and reporting requirements\n- Screening and coordination of a manageable ratio of participants\n- Access to on-call/temporary staff to meet fluctuating requirements?"},{"$f":"'3.Staff'!E10","v":"INPUT"},{"$f":"'3.Staff'!F10","v":"You need to consider what staffing mix is required to undertake the study. You need to identify who would complete each of the assessments in the study protocol. Once this has been done you can identify any new staff or skills required to execute the protocol."},{"$f":"'3.Staff'!I10","v":0},{"$f":"'3.Staff'!J10","v":0}]
[null,null,null,{"$f":"'3.Staff'!E11","v":"INPUT"},null,{"$f":"'3.Staff'!I11","v":0}]
[{"$f":"'3.Staff'!A12","v":3.0499999999999989},{"$f":"'3.Staff'!$C$8","v":"Does your site have an adequate and appropriate staffing (Education and Experience): \n"},{"$f":"'3.Staff'!D12","v":"Research Administrative Management:\n- adequately trained and experienced staff to assist with feasibility, \n- budget and contract negotiation,\n- ethics and research governance authorisation; \n- and oversight of SOPs (creation, implementation and evaluation)?"},{"$f":"'3.Staff'!E12","v":"INPUT"},{"$f":"'3.Staff'!F12","v":"Site feasibility, budget and contract negotiation, submission of Ethics application and Site Specific Application (SSA) are critical start-up activities that require a dedicated staff. Oversight of SOPs are also necessary to ensure the site is operating at quality standards."},{"$f":"'3.Staff'!I12","v":0},{"$f":"'3.Staff'!J12","v":0}]
[null,null,null,{"$f":"'3.Staff'!E13","v":"INPUT"},null,{"$f":"'3.Staff'!I13","v":0}]
[{"$f":"'3.Staff'!A14","v":3.0599999999999987},{"$f":"'3.Staff'!$C$14","v":"Do your staff have the appropriate training and experience:\n"},{"$f":"'3.Staff'!D14","v":"To run early phase trials?\n(Eg - A study coordinator should have appropriate trial experience before working in early phase\n- An Investigator should have experience in First in Human (FIH) and Phase 1b.)"},{"$f":"'3.Staff'!E14","v":"INPUT"},{"$f":"'3.Staff'!F14","v":"In early phase studies sites usually receive less developed protocols and study documentation during start up, compared with later phase studies where documentation is largely near final when first provided to site. Selected study personnel should expect to review study documents and provide feedback on feasibility, procedures and logistics during the start-up process."},{"$f":"'3.Staff'!I14","v":0},{"$f":"'3.Staff'!J14","v":0}]
[]
[null,null,null,{"$f":"'3.Staff'!E17","v":"INPUT"},null,{"$f":"'3.Staff'!I16","v":0}]
[]
[{"$f":"'4.Facility'!A4","v":4.01},{"$f":"'4.Facility'!$C$4","v":"Does your site have the following Participant/Patient facilities:"},{"$f":"'4.Facility'!D4","v":"Adequate participant areas and equipment to conduct and oversee treatment, procedures and participant monitoring?"},{"$f":"'4.Facility'!E4","v":"INPUT"},{"$f":"'4.Facility'!F4","v":"E.g. Day centre beds/chairs, rooms for screening, consultation, examination, participant emergency call bells, adequate participant monitoring area."},{"$f":"'4.Facility'!I4","v":0},{"$f":"'4.Facility'!J4","v":0}]
[null,null,null,{"$f":"'4.Facility'!E5","v":"INPUT"},null,{"$f":"'4.Facility'!I5","v":0}]
[{"$f":"'4.Facility'!A6","v":4.0199999999999996},{"$f":"'4.Facility'!$C$6","v":"Does your site have the following in relation to Site Equipment"},{"$f":"'4.Facility'!D6","v":"Lockable storage area for clinical trial information, test kits, trial specific equipment?"},{"$f":"'4.Facility'!E6","v":"INPUT"},{"$f":"'4.Facility'!F6","v":"E.g. Blood pressure monitoring, thermometer, ECG machines, weight scales, phlebotomy supplies. Trial specific requirements should be assessed at feasibility."},{"$f":"'4.Facility'!I6","v":0},{"$f":"'4.Facility'!J6","v":0}]
[null,null,null,{"$f":"'4.Facility'!E7","v":"INPUT"},null,{"$f":"'4.Facility'!I7","v":0}]
[{"$f":"'4.Facility'!A8","v":4.0299999999999994},{"$f":"'4.Facility'!$C$6","v":"Does your site have the following in relation to Site Equipment"},{"$f":"'4.Facility'!D8","v":"Equipment registers, including physical location and maintenance schedule?"},{"$f":"'4.Facility'!E8","v":"INPUT"},{"$f":"'4.Facility'!F8","v":"Asset register of all equipment, including maintenance logs (inc. calibration records)."},{"$f":"'4.Facility'!I8","v":0},{"$f":"'4.Facility'!J8","v":0}]
[null,null,null,{"$f":"'4.Facility'!E9","v":"INPUT"},null,{"$f":"'4.Facility'!I9","v":0}]
[{"$f":"'4.Facility'!A10","v":4.0399999999999991},{"$f":"'4.Facility'!$C$6","v":"Does your site have the following in relation to Site Equipment"},{"$f":"'4.Facility'!D10","v":"Power generators for instances of outages – including documented quality control (QC) testing?"},{"$f":"'4.Facility'!E10","v":"INPUT"},{"$f":"'4.Facility'!F10","v":"Important for temperature sensitive products, continuous infusions or sample/data integrity."},{"$f":"'4.Facility'!I10","v":0},{"$f":"'4.Facility'!J10","v":0}]
[null,null,null,{"$f":"'4.Facility'!E11","v":"INPUT"},null,{"$f":"'4.Facility'!I11","v":0}]
[{"$f":"'4.Facility'!A12","v":4.0499999999999989},{"$f":"'4.Facility'!$C$6","v":"Does your site have the following in relation to Site Equipment"},{"$f":"'4.Facility'!D12","v":"Other departmental or vendor – e.g. Pharmacy, Radiology, Ophthalmology, etc?"},{"$f":"'4.Facility'!E12","v":"INPUT"},{"$f":"'4.Facility'!F12","v":"Studies often require assessments by other departments/specialists. Some departments or vendors may need to perform assessments in line with specific requirements (such as RECIST imaging) or have certified processes (such as NATA accredited laboratories)."},{"$f":"'4.Facility'!I12","v":0},{"$f":"'4.Facility'!J12","v":0}]
[null,null,null,{"$f":"'4.Facility'!E13","v":"INPUT"},null,{"$f":"'4.Facility'!I13","v":0}]
[{"$f":"'4.Facility'!A14","v":4.0599999999999987},{"$f":"'4.Facility'!$C$6","v":"Does your site have the following in relation to Site Equipment"},{"$f":"'4.Facility'!D14","v":"Lockable storage area for clinical trial information, test kits, trial specific equipment?"},{"$f":"'4.Facility'!E14","v":"INPUT"},{"$f":"'4.Facility'!F14","v":"Sponsors provide a quantity of study kits that  require room for secure storage and access."},{"$f":"'4.Facility'!I14","v":0},{"$f":"'4.Facility'!J14","v":0}]
[null,null,null,{"$f":"'4.Facility'!E15","v":"INPUT"},null,{"$f":"'4.Facility'!I15","v":0}]
[{"$f":"'4.Facility'!A16","v":4.0699999999999985},{"$f":"'4.Facility'!$C$16","v":"Does your site have adequate Office / Admin facilities:"},{"$f":"'4.Facility'!D16","v":"Adequate IT capabilities; including computer(s), printers, photocopier, scanner, high speed internet?"},{"$f":"'4.Facility'!E16","v":"INPUT"},{"$f":"'4.Facility'!F16","v":"To support data entry and administrative trial activities. IT support should also be considered."},{"$f":"'4.Facility'!I16","v":0},{"$f":"'4.Facility'!J16","v":0}]
[null,null,null,{"$f":"'4.Facility'!E17","v":"INPUT"},null,{"$f":"'4.Facility'!I17","v":0}]
[{"$f":"'4.Facility'!A18","v":4.0799999999999983},{"$f":"'4.Facility'!$C$16","v":"Does your site have adequate Office / Admin facilities:"},{"$f":"'4.Facility'!D18","v":"Standard time (24-hour) and date format?"},{"$f":"'4.Facility'!E18","v":"INPUT"},{"$f":"'4.Facility'!F18","v":"To ensure consistent reporting by all study staff."},{"$f":"'4.Facility'!I18","v":0},{"$f":"'4.Facility'!J18","v":0}]
[null,null,null,{"$f":"'4.Facility'!E19","v":"INPUT"},null,{"$f":"'4.Facility'!I19","v":0}]
[{"$f":"'4.Facility'!A20","v":4.0899999999999981},{"$f":"'4.Facility'!$C$16","v":"Does your site have adequate Office / Admin facilities:"},{"$f":"'4.Facility'!D20","v":"Space for study monitoring visits?"},{"$f":"'4.Facility'!E20","v":"INPUT"},{"$f":"'4.Facility'!F20","v":"To ensure that the study sponsor has access to the site files for their audit purposes."},{"$f":"'4.Facility'!I20","v":0},{"$f":"'4.Facility'!J20","v":0}]
[null,null,null,{"$f":"'4.Facility'!E21","v":"INPUT"},null,{"$f":"'4.Facility'!I21","v":0}]
[{"$f":"'5.Device'!A4","v":5.01},{"$f":"'5.Device'!$C$4","v":"Does your site have the following for Investigational Device handling"},{"$f":"'5.Device'!D4","v":"Is there locked storage space for investigational device? \nDoes your site have a procedure for accessing investigational device for use in the study (chain of custody?)"},{"$f":"'5.Device'!E4","v":"INPUT"},{"$f":"'5.Device'!F4","v":"Early Phase investigational devices are generally not yet approved by the Therapeutic Goods Administration (TGA). Therefore, it has to be assured that they are only used on study patients."},{"$f":"'5.Device'!I4","v":0},{"$f":"'5.Device'!J4","v":0}]
[{"$f":"'5.Device'!A5","v":5.0199999999999996},{"$f":"'5.Device'!$C$4","v":"Does your site have the following for Investigational Device handling"},{"$f":"'5.Device'!D5","v":"Is there a plan for training for involved staff (PI, co-PIs, nursing and theatre staff) in the use of investigational device?"},{"$f":"'5.Device'!E5","v":"INPUT"},{"$f":"'5.Device'!F5","v":"The use of the investigational product might differ from existing products that the investigators are familiar with. It is also important that supporting staff (scrub nurse etc.) are trained on the investigational device."},{"$f":"'5.Device'!I5","v":0},{"$f":"'5.Device'!J5","v":0}]
[{"$f":"'5.Device'!A6","v":5.0299999999999994},{"$f":"'5.Device'!$C$4","v":"Does your site have the following for Investigational Device handling"},{"$f":"'5.Device'!D6","v":"Do you  have a procedure for device handling including;\n- How expired stock is monitored and reordered?\n- Maintenance and accountability of stock?\n- Stock integrity, including temperature monitoring?"},{"$f":"'5.Device'!E6","v":"INPUT"},{"$f":"'5.Device'!F6","v":"Since the investigational product is kept locked away from standard stock, special care has to be taken to monitor its use-before-dates."},{"$f":"'5.Device'!I6","v":0},{"$f":"'5.Device'!J6","v":0}]
[{"$f":"'5.Device'!A7","v":5.0399999999999991},{"$f":"'5.Device'!$C$7","v":"Are you aware of the following Generic Resource Links"},{"$f":"'5.Device'!D7","v":"MTAA website?"},{"$f":"'5.Device'!E7","v":"INPUT"},{"$f":"'5.Device'!F7","v":0},{"$f":"'5.Device'!I7","v":0},{"$f":"'5.Device'!J7","v":0}]
[{"$f":"'6.QAQM'!A4","v":6.01},{"$f":"'6.QAQM'!$C$4","v":"Does your site have an internal Quality Assurance Procedure?"},{"$f":"'6.QAQM'!D4","v":"Does your site have a Quality Assurance (QA) procedure to test the robustness of your site practices, including emergency procedures and data capture? Have you established timelines for these to be tested?"},{"$f":"'6.QAQM'!E4","v":"INPUT"},{"$f":"'6.QAQM'!F4","v":"Required as per Site Standard Operating Procedures (SOP)."},{"$f":"'6.QAQM'!I4","v":0},{"$f":"'6.QAQM'!J4","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E5","v":"INPUT"},null,{"$f":"'6.QAQM'!I5","v":0}]
[{"$f":"'6.QAQM'!A6","v":6.02},{"$f":"'6.QAQM'!$C$4","v":"Does your site have an internal Quality Assurance Procedure?"},{"$f":"'6.QAQM'!D6","v":"Do you have Source Data Verification (SDV) procedures in place if required?"},{"$f":"'6.QAQM'!E6","v":"INPUT"},{"$f":"'6.QAQM'!F6","v":"Required as per Site SOP."},{"$f":"'6.QAQM'!I6","v":0},{"$f":"'6.QAQM'!J6","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E7","v":"INPUT"},null,{"$f":"'6.QAQM'!I7","v":0}]
[{"$f":"'6.QAQM'!A8","v":6.0299999999999994},{"$f":"'6.QAQM'!$C$4","v":"Does your site have an internal Quality Assurance Procedure?"},{"$f":"'6.QAQM'!D8","v":"Do you have a nominated person to perform the quality assurance?"},{"$f":"'6.QAQM'!E8","v":"INPUT"},{"$f":"'6.QAQM'!F8","v":"This can be any delegated staff with appropriate experience. "},{"$f":"'6.QAQM'!I8","v":0},{"$f":"'6.QAQM'!J8","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E9","v":"INPUT"},null,{"$f":"'6.QAQM'!I9","v":0}]
[{"$f":"'6.QAQM'!A10","v":6.0399999999999991},{"$f":"'6.QAQM'!$C$4","v":"Does your site have an internal Quality Assurance Procedure?"},{"$f":"'6.QAQM'!D10","v":"Have you established timelines (i.e. frequency and duration) for the quality assurance activities?"},{"$f":"'6.QAQM'!E10","v":"INPUT"},{"$f":"'6.QAQM'!F10","v":"Required as per Site SOP."},{"$f":"'6.QAQM'!I10","v":0},{"$f":"'6.QAQM'!J10","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E11","v":"INPUT"},null,{"$f":"'6.QAQM'!I11","v":0}]
[{"$f":"'6.QAQM'!A12","v":6.0499999999999989},{"$f":"'6.QAQM'!$C$4","v":"Does your site have an internal Quality Assurance Procedure?"},{"$f":"'6.QAQM'!D12","v":"Do your staff have adequate time and opportunity to complete and review source data and queries raised from the source data?"},{"$f":"'6.QAQM'!E12","v":"INPUT"},{"$f":"'6.QAQM'!F12","v":"To ensure that data capture is accurate and timely."},{"$f":"'6.QAQM'!I12","v":0},{"$f":"'6.QAQM'!J12","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E13","v":"INPUT"},null,{"$f":"'6.QAQM'!I13","v":0}]
[{"$f":"'6.QAQM'!A14","v":6.0599999999999987},{"$f":"'6.QAQM'!$C$4","v":"Does your site have an internal Quality Assurance Procedure?"},{"$f":"'6.QAQM'!D14","v":"Are all study documents, forms and databases contemporaneously updated and accessible for data validation?"},{"$f":"'6.QAQM'!E14","v":"INPUT"},{"$f":"'6.QAQM'!F14","v":"To ensure that data capture and reporting is accurate and timely."},{"$f":"'6.QAQM'!I14","v":0},{"$f":"'6.QAQM'!J14","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E15","v":"INPUT"},null,{"$f":"'6.QAQM'!I15","v":0}]
[{"$f":"'6.QAQM'!A16","v":6.0699999999999985},{"$f":"'6.QAQM'!$C$4","v":"Does your site have an internal Quality Assurance Procedure?"},{"$f":"'6.QAQM'!D16","v":"Do you perform a protocol risk assessment prior to implementation?"},{"$f":"'6.QAQM'!E16","v":"INPUT"},{"$f":"'6.QAQM'!F16","v":"Pre-assessment will enable site to adequately gauge trial requirements and impact on resources."},{"$f":"'6.QAQM'!I16","v":0},{"$f":"'6.QAQM'!J16","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E17","v":"INPUT"},null,{"$f":"'6.QAQM'!I17","v":0}]
[{"$f":"'6.QAQM'!A18","v":6.0799999999999983},{"$f":"'6.QAQM'!$C$18","v":"Does your site have evaluation processes in place and a CAPA (Corrective and Preventative Action) process for the following:"},{"$f":"'6.QAQM'!D18","v":"Protocol deviations / violations?"},{"$f":"'6.QAQM'!E18","v":"INPUT"},{"$f":"'6.QAQM'!F18","v":"Required as per GCP Guidelines."},{"$f":"'6.QAQM'!I18","v":0},{"$f":"'6.QAQM'!J18","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E19","v":"INPUT"},null,{"$f":"'6.QAQM'!I19","v":0}]
[{"$f":"'6.QAQM'!A20","v":6.0899999999999981},{"$f":"'6.QAQM'!$C$18","v":"Does your site have evaluation processes in place and a CAPA (Corrective and Preventative Action) process for the following:"},{"$f":"'6.QAQM'!D20","v":"Site staff complaints?"},{"$f":"'6.QAQM'!E20","v":"INPUT"},{"$f":"'6.QAQM'!F20","v":"Required as per Site SOP."},{"$f":"'6.QAQM'!I20","v":0},{"$f":"'6.QAQM'!J20","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E21","v":"INPUT"},null,{"$f":"'6.QAQM'!I21","v":0}]
[{"$f":"'6.QAQM'!A22","v":6.0999999999999979},{"$f":"'6.QAQM'!$C$18","v":"Does your site have evaluation processes in place and a CAPA (Corrective and Preventative Action) process for the following:"},{"$f":"'6.QAQM'!D22","v":"Site-internal audit / monitoring findings?"},{"$f":"'6.QAQM'!E22","v":"INPUT"},{"$f":"'6.QAQM'!F22","v":"Required as per Site SOP."},{"$f":"'6.QAQM'!I22","v":0},{"$f":"'6.QAQM'!J22","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E23","v":"INPUT"},null,{"$f":"'6.QAQM'!I23","v":0}]
[{"$f":"'6.QAQM'!A24","v":6.1099999999999977},{"$f":"'6.QAQM'!$C$18","v":"Does your site have evaluation processes in place and a CAPA (Corrective and Preventative Action) process for the following:"},{"$f":"'6.QAQM'!D24","v":"Study specific monitor visits?"},{"$f":"'6.QAQM'!E24","v":"INPUT"},{"$f":"'6.QAQM'!F24","v":"To ensure Sponsor requirements are met."},{"$f":"'6.QAQM'!I24","v":0},{"$f":"'6.QAQM'!J24","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E25","v":"INPUT"},null,{"$f":"'6.QAQM'!I25","v":0}]
[{"$f":"'6.QAQM'!A26","v":6.1199999999999974},{"$f":"'6.QAQM'!$C$18","v":"Does your site have evaluation processes in place and a CAPA (Corrective and Preventative Action) process for the following:"},{"$f":"'6.QAQM'!D26","v":"Operational issues identified at your site?"},{"$f":"'6.QAQM'!E26","v":"INPUT"},{"$f":"'6.QAQM'!F26","v":"Required as per Site SOP."},{"$f":"'6.QAQM'!I26","v":0},{"$f":"'6.QAQM'!J26","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E27","v":"INPUT"},null,{"$f":"'6.QAQM'!I27","v":0}]
[{"$f":"'6.QAQM'!A28","v":6.1299999999999972},{"$f":"'6.QAQM'!$C$18","v":"Does your site have evaluation processes in place and a CAPA (Corrective and Preventative Action) process for the following:"},{"$f":"'6.QAQM'!D28","v":"Patient withdrawal from study?"},{"$f":"'6.QAQM'!E28","v":"INPUT"},{"$f":"'6.QAQM'!F28","v":"Required as per study and GCP guidelines."},{"$f":"'6.QAQM'!I28","v":0},{"$f":"'6.QAQM'!J28","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E29","v":"INPUT"},null,{"$f":"'6.QAQM'!I29","v":0}]
[{"$f":"'6.QAQM'!A30","v":6.139999999999997},{"$f":"'6.QAQM'!$C$18","v":"Does your site have evaluation processes in place and a CAPA (Corrective and Preventative Action) process for the following:"},{"$f":"'6.QAQM'!D30","v":"Research participants complaints?"},{"$f":"'6.QAQM'!E30","v":"INPUT"},{"$f":"'6.QAQM'!F30","v":"Required as per GCP and HREC guidelines."},{"$f":"'6.QAQM'!I30","v":0},{"$f":"'6.QAQM'!J30","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E31","v":"INPUT"},null,{"$f":"'6.QAQM'!I31","v":0}]
[{"$f":"'6.QAQM'!A32","v":6.1499999999999968},{"$f":"'6.QAQM'!$C$32","v":"Do you have a CAPA (Corrective and Preventive Action) procedure? Consider the following :"},{"$f":"'6.QAQM'!D32","v":"Process for \nIncident identification?\nDevelopment of action plan based on cause analysis?\nAction plan validation and implementation?\nDocumentation of standard operating procedure as a result of CAPA?"},{"$f":"'6.QAQM'!E32","v":"INPUT"},{"$f":"'6.QAQM'!F32","v":"May be required as per Site SOP."},{"$f":"'6.QAQM'!I32","v":0},{"$f":"'6.QAQM'!J32","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E33","v":"INPUT"},null,{"$f":"'6.QAQM'!I33","v":0}]
[{"$f":"'6.QAQM'!A35","v":6.1599999999999966},{"$f":"'6.QAQM'!$C$35","v":"Does your site have a Participant Management Database?"},{"$f":"'6.QAQM'!D35","v":"Do you have a system to capture and record potential trial participants?"},{"$f":"'6.QAQM'!E35","v":"INPUT"},{"$f":"'6.QAQM'!F35","v":"Can assist in identifying participants and estimating recruitment numbers. Consider your site's patient population and referral networks.  "},{"$f":"'6.QAQM'!I35","v":0},{"$f":"'6.QAQM'!J35","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E36","v":"INPUT"},null,{"$f":"'6.QAQM'!I36","v":0}]
[{"$f":"'6.QAQM'!A37","v":6.1699999999999964},{"$f":"'6.QAQM'!$C$37","v":"Does your site record and monitor Study Metrics / KPIs?"},{"$f":"'6.QAQM'!D37","v":"Do you have a system to capture and record study metrics/KPIs?"},{"$f":"'6.QAQM'!E37","v":"INPUT"},{"$f":"'6.QAQM'!F37","v":"This system will provide information on site trial activity and can assist in organisation metric reporting requirements."},{"$f":"'6.QAQM'!I37","v":0},{"$f":"'6.QAQM'!J37","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E38","v":"INPUT"},null,{"$f":"'6.QAQM'!I38","v":0}]
[{"$f":"'6.QAQM'!A39","v":6.1799999999999962},{"$f":"'6.QAQM'!$C$39","v":"Does your site have a system to capture and record recommended KPIs?"},{"$f":"'6.QAQM'!D39","v":"Some examples include :\n1. Current actual recruitment versus target recruitment (%)\n2. Median Calendar Days from Human Research Ethics Committee Office (HREC) submission to HREC approval. \n3. Median Calendar Days from Research Governance Office (RGO) submission to RGO authorisation.\n4. Median calendar days from Contract (CTRA) fully executed to site activation.\n5. Median calendar days from site activation to first patient enrolled on trial?"},{"$f":"'6.QAQM'!E39","v":"INPUT"},{"$f":"'6.QAQM'!F39","v":"Minimal data set of performance metrics will assist sites in determining efficacy and efficiency in sites performance and assist in eliminating barriers to improve performance. "},{"$f":"'6.QAQM'!I39","v":0},{"$f":"'6.QAQM'!J39","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E40","v":"INPUT"},null,{"$f":"'6.QAQM'!I40","v":0}]
[{"$f":"'6.QAQM'!A41","v":6.1899999999999959},{"$f":"'6.QAQM'!$C$41","v":"Does your site have SOPs covering the following topics:"},{"$f":"'6.QAQM'!D41","v":"Do you have resource for the review and monitoring of any GCP compliance updates / trends to ensure quality improvement is maintained at your site? "},{"$f":"'6.QAQM'!E41","v":"INPUT"},{"$f":"'6.QAQM'!F41","v":"Description of investigator qualifications, GCP and delegation log procedures, feasibility assessment processes and RGO and HREC requirements."},{"$f":"'6.QAQM'!I41","v":0},{"$f":"'6.QAQM'!J41","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E42","v":"INPUT"},null,{"$f":"'6.QAQM'!I42","v":0}]
[{"$f":"'6.QAQM'!A43","v":6.1999999999999957},{"$f":"'6.QAQM'!$C$41","v":"Does your site have SOPs covering the following topics:"},{"$f":"'6.QAQM'!D43","v":"Training and Quality management?"},{"$f":"'6.QAQM'!E43","v":"INPUT"},{"$f":"'6.QAQM'!F43","v":"Document procedures for site initiation visits, protocol-specific training and ongoing supplemental training, Outline all QC procedures, CTMS software in use and audit procedures."},{"$f":"'6.QAQM'!I43","v":0},{"$f":"'6.QAQM'!J43","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E44","v":"INPUT"},null,{"$f":"'6.QAQM'!I44","v":0}]
[{"$f":"'6.QAQM'!A45","v":6.2099999999999955},{"$f":"'6.QAQM'!$C$41","v":"Does your site have SOPs covering the following topics:"},{"$f":"'6.QAQM'!D45","v":"Participant recruitment?"},{"$f":"'6.QAQM'!E45","v":"INPUT"},{"$f":"'6.QAQM'!F45","v":"Describe how your organisation facilitates recruitment. Describe consenting processes, privacy and confidentiality of participants and reimbursements. Are there any procedures to reduce risks of over-volunteering if applicable."},{"$f":"'6.QAQM'!I45","v":0},{"$f":"'6.QAQM'!J45","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E46","v":"INPUT"},null,{"$f":"'6.QAQM'!I46","v":0}]
[{"$f":"'6.QAQM'!A47","v":6.2199999999999953},{"$f":"'6.QAQM'!$C$41","v":"Does your site have SOPs covering the following topics:"},{"$f":"'6.QAQM'!D47","v":"Safety Management?"},{"$f":"'6.QAQM'!E47","v":"INPUT"},{"$f":"'6.QAQM'!F47","v":"Management and reporting of serious adverse events, including safety monitoring and emergency equipment on site."},{"$f":"'6.QAQM'!I47","v":0},{"$f":"'6.QAQM'!J47","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E48","v":"INPUT"},null,{"$f":"'6.QAQM'!I48","v":0}]
[{"$f":"'6.QAQM'!A49","v":6.2299999999999951},{"$f":"'6.QAQM'!$C$41","v":"Does your site have SOPs covering the following topics:"},{"$f":"'6.QAQM'!D49","v":"Pharmacy/Device Procedures?"},{"$f":"'6.QAQM'!E49","v":"INPUT"},{"$f":"'6.QAQM'!F49","v":"Describe procedures for IMP/device delivery, storage, monitoring, accountability and destruction, including chain of custody documentation. Consider the suitability of the administration equipment and potential interactions with the IMP."},{"$f":"'6.QAQM'!I49","v":0},{"$f":"'6.QAQM'!J49","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E50","v":"INPUT"},null,{"$f":"'6.QAQM'!I50","v":0}]
[{"$f":"'6.QAQM'!A51","v":6.2399999999999949},{"$f":"'6.QAQM'!$C$41","v":"Does your site have SOPs covering the following topics:"},{"$f":"'6.QAQM'!D51","v":"Supplies and vendors?"},{"$f":"'6.QAQM'!E51","v":"INPUT"},{"$f":"'6.QAQM'!F51","v":"List and describe service agreements with any third party vendors. Maintenance of site equipment can be included here."},{"$f":"'6.QAQM'!I51","v":0},{"$f":"'6.QAQM'!J51","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E52","v":"INPUT"},null,{"$f":"'6.QAQM'!I52","v":0}]
[{"$f":"'6.QAQM'!A53","v":6.2499999999999947},{"$f":"'6.QAQM'!$C$53","v":"Does your site assess your site capabilities, resources and operational constraints against each protocol requirements?"},{"$f":"'6.QAQM'!D53","v":"Consider the requirements, treatment and procedures and staffing, in additional to operational requirements of the protocol and the interoperability with your site capabilities, resources and operational constraints. Have you identified what days study procedures could be conducted (e.g. Mondays, over weekends etc)? "},{"$f":"'6.QAQM'!E53","v":"INPUT"},{"$f":"'6.QAQM'!F53","v":0},{"$f":"'6.QAQM'!I53","v":0},{"$f":"'6.QAQM'!J53","v":0}]
[null,null,null,{"$f":"'6.QAQM'!E54","v":"INPUT"},null,{"$f":"'6.QAQM'!I54","v":0}]
[{"$f":"'7.Participant'!A4","v":7.01},{"$f":"'7.Participant'!$C$4","v":"Does your site use Participant Orientation and General Information"},{"$f":"'7.Participant'!D4","v":"Do you provide participant orientation to the study? "},{"$f":"'7.Participant'!E4","v":"INPUT"},{"$f":"'7.Participant'!F4","v":"This includes a tour of all areas to be accessed by the participant (including location of emergency call button).  Disabled access should be available.  "},{"$f":"'7.Participant'!I4","v":0},{"$f":"'7.Participant'!J4","v":0}]
[null,null,null,{"$f":"'7.Participant'!E5","v":"INPUT"},null,{"$f":"'7.Participant'!I5","v":0}]
[{"$f":"'7.Participant'!A6","v":7.02},{"$f":"'7.Participant'!$C$4","v":"Does your site use Participant Orientation and General Information"},{"$f":"'7.Participant'!D6","v":"Do you have patient/participant information available covering ;\n- generic clinical trial information\n- disease indication, and\n- support groups if applicable?"},{"$f":"'7.Participant'!E6","v":"INPUT"},{"$f":"'7.Participant'!F6","v":"As per the PICF and other institutional guidelines."},{"$f":"'7.Participant'!I6","v":0},{"$f":"'7.Participant'!J6","v":0}]
[null,null,null,{"$f":"'7.Participant'!E7","v":"INPUT"},null,{"$f":"'7.Participant'!I7","v":0}]
[{"$f":"'7.Participant'!A8","v":7.0299999999999994},{"$f":"'7.Participant'!$C$8","v":"Does your site have an SOP or procedure outlining the following :"},{"$f":"'7.Participant'!D8","v":"Participant provision of all applicable participant facing material, including contact information, any applicable participant training, study documents?"},{"$f":"'7.Participant'!E8","v":"INPUT"},{"$f":"'7.Participant'!F8","v":"As per the PICF and other institutional guidelines."},{"$f":"'7.Participant'!I8","v":0},{"$f":"'7.Participant'!J8","v":0}]
[null,null,null,{"$f":"'7.Participant'!E9","v":"INPUT"},null,{"$f":"'7.Participant'!I9","v":0}]
[{"$f":"'7.Participant'!A10","v":7.0399999999999991},{"$f":"'7.Participant'!$C$8","v":"Does your site have an SOP or procedure outlining the following :"},{"$f":"'7.Participant'!D10","v":"Privacy and confidentiality in relation to participants and their personal/medical information?"},{"$f":"'7.Participant'!E10","v":"INPUT"},{"$f":"'7.Participant'!F10","v":"As per the PICF and other institutional guidelines."},{"$f":"'7.Participant'!I10","v":0},{"$f":"'7.Participant'!J10","v":0}]
[null,null,null,{"$f":"'7.Participant'!E11","v":"INPUT"},null,{"$f":"'7.Participant'!I11","v":0}]
[{"$f":"'7.Participant'!A12","v":7.0499999999999989},{"$f":"'7.Participant'!$C$8","v":"Does your site have an SOP or procedure outlining the following :"},{"$f":"'7.Participant'!D12","v":"Participant communication; commencing at screening, through active participation and following the end of study participation, and should consider the provision of consent for communication with a participants healthcare professional?"},{"$f":"'7.Participant'!E12","v":"INPUT"},{"$f":"'7.Participant'!F12","v":"As per the PICF and other institutional guidelines.  Can you provide a really clear outline of the study."},{"$f":"'7.Participant'!I12","v":0},{"$f":"'7.Participant'!J12","v":0}]
[null,null,null,{"$f":"'7.Participant'!E13","v":"INPUT"},null,{"$f":"'7.Participant'!I13","v":0}]
[{"$f":"'7.Participant'!A14","v":7.0599999999999987},{"$f":"'7.Participant'!$C$8","v":"Does your site have an SOP or procedure outlining the following :"},{"$f":"'7.Participant'!D14","v":"Site specific Participant emergency guidelines including provision of alert card and participant education for reporting adverse events (AE), and presentation in the event of serious adverse medical event (SAE)?"},{"$f":"'7.Participant'!E14","v":"INPUT"},{"$f":"'7.Participant'!F14","v":"As per the PICF and other institutional guidelines. Many sponsored studies will provide a participant card (alert card), if not study specific the site should have a generic alert card to provide to clinical trial participants."},{"$f":"'7.Participant'!I14","v":0},{"$f":"'7.Participant'!J14","v":0}]
[null,null,null,{"$f":"'7.Participant'!E15","v":"INPUT"},null,{"$f":"'7.Participant'!I15","v":0}]
[{"$f":"'7.Participant'!A16","v":7.0699999999999985},{"$f":"'7.Participant'!$C$8","v":"Does your site have an SOP or procedure outlining the following :"},{"$f":"'7.Participant'!D16","v":"Expectations of Participants (including behaviour) e.g. “House Rules”?"},{"$f":"'7.Participant'!E16","v":"INPUT"},{"$f":"'7.Participant'!F16","v":"As per the PICF and other institutional guidelines."},{"$f":"'7.Participant'!I16","v":0},{"$f":"'7.Participant'!J16","v":0}]
[null,null,null,{"$f":"'7.Participant'!E17","v":"INPUT"},null,{"$f":"'7.Participant'!I17","v":0}]
[{"$f":"'7.Participant'!A18","v":7.0799999999999983},{"$f":"'7.Participant'!$C$8","v":"Does your site have an SOP or procedure outlining the following :"},{"$f":"'7.Participant'!D18","v":"Participant Reimbursement guidelines and a process for reimbursement?"},{"$f":"'7.Participant'!E18","v":"INPUT"},{"$f":"'7.Participant'!F18","v":"As per the PICF and other institutional guidelines."},{"$f":"'7.Participant'!I18","v":0},{"$f":"'7.Participant'!J18","v":0}]
[null,null,null,{"$f":"'7.Participant'!E19","v":"INPUT"},null,{"$f":"'7.Participant'!I19","v":0}]
[{"$f":"'7.Participant'!A20","v":7.0899999999999981},{"$f":"'7.Participant'!$C$8","v":"Does your site have an SOP or procedure outlining the following :"},{"$f":"'7.Participant'!D20","v":"Management of complaints?"},{"$f":"'7.Participant'!E20","v":"INPUT"},{"$f":"'7.Participant'!F20","v":"As per the PICF and other institutional guidelines."},{"$f":"'7.Participant'!I20","v":0},{"$f":"'7.Participant'!J20","v":0}]
[]
[]
[]
[]
[]
[null,null,null,{"$f":"'7.Participant'!E31","v":"INPUT"},null,{"$f":"'7.Participant'!I31","v":0}]
[]
[]
[]
[]
[{"$f":"'8.Pharmacy'!A4","v":8.01},{"$f":"'8.Pharmacy'!C4","v":"Does your pharmacy support and have the capability of doing what is required for the study"},{"$f":"'8.Pharmacy'!D4","v":"Is you Pharmacist involved in reviewing the pharmacy manual and protocol in the feasibility stage?"},{"$f":"'8.Pharmacy'!E4","v":"INPUT"},{"$f":"'8.Pharmacy'!F4","v":"These are core activities for clinical trial pharmacies. Can an alternative pharmacy vendor be utilized if on-site pharmacy facilities are not available?"},{"$f":"'8.Pharmacy'!I4","v":0},{"$f":"'8.Pharmacy'!J5","v":0}]
[{"$f":"'8.Pharmacy'!A6","v":8.02},{"$f":"'8.Pharmacy'!$C$6","v":"Does your pharmacy have the following capability of :"},{"$f":"'8.Pharmacy'!D6","v":"Attending to IMP ordering, delivery, packaging, labelling,  storage, dispensing, handling, return, destruction, quarantine procedure, double blind and rescue medicine and corresponding Standard Operating Procedures (SOP) for all procedures?"},{"$f":"'8.Pharmacy'!E6","v":"INPUT"},{"$f":"'8.Pharmacy'!F6","v":"Adequate resources are essential."},{"$f":"'8.Pharmacy'!I6","v":0},{"$f":"'8.Pharmacy'!J6","v":0}]
[{"$f":"'8.Pharmacy'!A7","v":8.0299999999999994},{"$f":"'8.Pharmacy'!$C$6","v":"Does your pharmacy have the following capability of :"},{"$f":"'8.Pharmacy'!D7","v":"Second check when dispensing the IMP (technician and pharmacist, or pharmacist and pharmacist)?"},{"$f":"'8.Pharmacy'!E7","v":"INPUT"},{"$f":"'8.Pharmacy'!F7","v":"Please refer to your state's pharmacy guidance and legal obligations when handling, dispensing and supplying drugs."},{"$f":"'8.Pharmacy'!I7","v":0},{"$f":"'8.Pharmacy'!J7","v":0}]
[{"$f":"'8.Pharmacy'!A8","v":8.0399999999999991},{"$f":"'8.Pharmacy'!$C$6","v":"Does your pharmacy have the following capability of :"},{"$f":"'8.Pharmacy'!D8","v":"Protocol trained pharmacist accessible on dosing days?"},{"$f":"'8.Pharmacy'!E8","v":"INPUT"},{"$f":"'8.Pharmacy'!F8","v":0},{"$f":"'8.Pharmacy'!I8","v":0},{"$f":"'8.Pharmacy'!J8","v":0}]
[{"$f":"'8.Pharmacy'!A9","v":8.0499999999999989},{"$f":"'8.Pharmacy'!$C$6","v":"Does your pharmacy have the following capability of :"},{"$f":"'8.Pharmacy'!D9","v":"Area to accommodate monitoring or auditing visit?"},{"$f":"'8.Pharmacy'!E9","v":"INPUT"},{"$f":"'8.Pharmacy'!F9","v":"Typically sponsor requirement to perform accountability."},{"$f":"'8.Pharmacy'!I9","v":0},{"$f":"'8.Pharmacy'!J9","v":0}]
[{"$f":"'8.Pharmacy'!A10","v":8.0599999999999987},{"$f":"'8.Pharmacy'!$C$6","v":"Does your pharmacy have the following capability of :"},{"$f":"'8.Pharmacy'!D10","v":"After hours on-call pharmacist (not necessarily clinical trials pharmacist)?"},{"$f":"'8.Pharmacy'!E10","v":"INPUT"},{"$f":"'8.Pharmacy'!F10","v":0},{"$f":"'8.Pharmacy'!I10","v":0},{"$f":"'8.Pharmacy'!J10","v":0}]
[{"$f":"'8.Pharmacy'!A11","v":8.0699999999999985},{"$f":"'8.Pharmacy'!$C$11","v":"Does your site have appropriate spill management for GMOs"},{"$f":"'8.Pharmacy'!D11","v":"For Genetically Modified Organisms (GMO) trials, required procedures, equipment and SOPs for product handing, as outlined by the Office of the Gene Technology Regulator (OGTR)?"},{"$f":"'8.Pharmacy'!E11","v":"INPUT"},{"$f":"'8.Pharmacy'!F11","v":"The use of GMO's and biologics in clinical trials is an emerging treatment field of research.  Sites must consider contents of spill kits, working withiin the DNIR license, specific training requried for nursing staff and the site requirement of a PC2 lab."},{"$f":"'8.Pharmacy'!I11","v":0},{"$f":"'8.Pharmacy'!J11","v":0}]
[{"$f":"'9.Lab'!A4","v":9.01},{"$f":"'9.Lab'!$C$4","v":"Will your site be responsible for processing biological samples?"},{"$f":"'9.Lab'!D4","v":"Will your site prepare or process biological samples for analysis at either a local or central laboratory?"},{"$f":"'9.Lab'!E4","v":"INPUT"},{"$f":"'9.Lab'!F4","v":"National Association of Testing Authority (NATA) sets out the standards that bioanalytical facilities should adhere to. Sponsor typically determines laboratory selected."},{"$f":"'9.Lab'!I4","v":0},{"$f":"'9.Lab'!J4","v":0}]
[{"$f":"'9.Lab'!A6","v":9.02},{"$f":"'9.Lab'!$C$6","v":"Does your Laboratory (lab) utilize the following safe lab practices?"},{"$f":"'9.Lab'!D6","v":"Does your site have appropriate equipment for the procedures you perform;\n- Personal protective equipment (PPE)\n- Spill Kits, eye wash or shower\n- Centrifuges, vortex, micropipette etc\n- Biohazard/biological waste bins?"},{"$f":"'9.Lab'!E6","v":"INPUT"},{"$f":"'9.Lab'!F6","v":"Hazardous material must be handled and disposed of in accordance with national and state requirements."},{"$f":"'9.Lab'!I6","v":0},{"$f":"'9.Lab'!J7","v":0}]
[{"$f":"'9.Lab'!A8","v":9.0299999999999994},{"$f":"'9.Lab'!$C$6","v":"Does your Laboratory (lab) utilize the following safe lab practices?"},{"$f":"'9.Lab'!D8","v":"Does your site have a  documented procedure for:\n- Study specific sample preparation training\n- Sterilization and disinfection process for shipping and return of goods?\n- Procedure for accidental exposure to biological material?\n- Procedure for management of a biological or chemical spill?"},{"$f":"'9.Lab'!E8","v":"INPUT"},{"$f":"'9.Lab'!F8","v":"Laboratory personnel handling potentially hazardous material require procedures to ensure safe sample handling and spill or exposure management processes."},{"$f":"'9.Lab'!I8","v":0},{"$f":"'9.Lab'!J8","v":0}]
[{"$f":"'9.Lab'!A9","v":9.0399999999999991},{"$f":"'9.Lab'!$C$6","v":"Does your Laboratory (lab) utilize the following safe lab practices?"},{"$f":"'9.Lab'!D9","v":"International Air Transport Association (IATA) certified Dangerous Goods Training for handling and shipping 'dangerous good like biological samples'?"},{"$f":"'9.Lab'!E9","v":"INPUT"},{"$f":"'9.Lab'!F9","v":"Part 92 of Civil Aviation Safety Regulations (CASR) prescribes the minimum safety requirements for the consignment and carriage of dangerous goods by air."},{"$f":"'9.Lab'!I9","v":0},{"$f":"'9.Lab'!J9","v":0}]
[{"$f":"'9.Lab'!A10","v":9.0499999999999989},{"$f":"'9.Lab'!$C$6","v":"Does your Laboratory (lab) utilize the following safe lab practices?"},{"$f":"'9.Lab'!D10","v":"Are Materials Safety Data Sheets (MSDS) and Chemical Register available for all chemicals used in the laboratory?"},{"$f":"'9.Lab'!E10","v":"INPUT"},{"$f":"'9.Lab'!F10","v":"A hazardous chemicals register is required under the Work Health and Safety Regulations to be prepared and kept up-to-date"},{"$f":"'9.Lab'!I10","v":0},{"$f":"'9.Lab'!J10","v":0}]
[{"$f":"'9.Lab'!A11","v":9.0599999999999987},{"$f":"'9.Lab'!$C$11","v":"Does your site have the following equipment available on site?"},{"$f":"'9.Lab'!D11","v":"Is a biohazard or laminar flow unit available on site? Biohazard waste bin available?"},{"$f":"'9.Lab'!E11","v":"INPUT"},{"$f":"'9.Lab'!F11","v":"Requirement for the use and compounding of certain hazardous chemicals."},{"$f":"'9.Lab'!I11","v":0},{"$f":"'9.Lab'!J12","v":0}]
[{"$f":"'9.Lab'!A13","v":9.0699999999999985},{"$f":"'9.Lab'!$C$11","v":"Does your site have the following equipment available on site?"},{"$f":"'9.Lab'!D13","v":"Does the site have access to dry ice for shipping samples?"},{"$f":"'9.Lab'!E13","v":"INPUT"},{"$f":"'9.Lab'!F13","v":"Many samples need to be shipped on dry ice."},{"$f":"'9.Lab'!I13","v":0},{"$f":"'9.Lab'!J13","v":0}]
[{"$f":"'9.Lab'!A14","v":9.0799999999999983},{"$f":"'9.Lab'!$C$11","v":"Does your site have the following equipment available on site?"},{"$f":"'9.Lab'!D14","v":"Are there procedures and equipment available to manage biological and chemical spills?"},{"$f":"'9.Lab'!E14","v":"INPUT"},{"$f":"'9.Lab'!F14","v":"Sites should have a written procedure to minimise risk of exposure to blood and chemical spills."},{"$f":"'9.Lab'!I14","v":0},{"$f":"'9.Lab'!J14","v":0}]
[{"$f":"'9.Lab'!A15","v":9.0899999999999981},{"$f":"'9.Lab'!$C$15","v":"Are the following sample handling procedures available on site?"},{"$f":"'9.Lab'!D15","v":"Does the site have a process for the collection, management and handling of biological samples? Including biological sample handling logs?"},{"$f":"'9.Lab'!E15","v":"INPUT"},{"$f":"'9.Lab'!F15","v":"Sites should have a written procedure (SOP) detailing their sample management processes. "},{"$f":"'9.Lab'!I15","v":0},{"$f":"'9.Lab'!J15","v":0}]
[]
[{"$f":"'9.Lab'!A17","v":9.0999999999999979},{"$f":"'9.Lab'!$C$17","v":"Are GMO products/specimens going to be processed on site?"},{"$f":"'9.Lab'!D17","v":"Does the site have an Institutional Biosafety Committee (IBC) able to evaluate the use of Genetically Modified Organisms (GMOs) at site?"},{"$f":"'9.Lab'!E17","v":"INPUT"},{"$f":"'9.Lab'!F17","v":"Organisations dealing with GMOs must be accredited and must have an Institutional Biosafety Committee (IBC), or access to an IBC, which reviews research applications and monitors certified facilities."},{"$f":"'9.Lab'!I17","v":0},{"$f":"'9.Lab'!J17","v":0}]
[{"$f":"'9.Lab'!A18","v":9.1099999999999977},{"$f":"'9.Lab'!$C$17","v":"Are GMO products/specimens going to be processed on site?"},{"$f":"'9.Lab'!D18","v":"Does the processing laboratory have the appropriate level of containment to manage samples within the licensing conditions? "},{"$f":"'9.Lab'!E18","v":"INPUT"},{"$f":"'9.Lab'!F18","v":"The Office of the Gene Technology Regulator (OGTR) reviews GMO applications and issues licenses detailing the level of precautions to be taken; e.g.: PC1, PC2 or higher."},{"$f":"'9.Lab'!I18","v":0},{"$f":"'9.Lab'!J18","v":0}]
[]
[{"$f":"'10.CTRA'!A4","v":10.01},{"$f":"'10.CTRA'!$C$4","v":"Does your site utilize standard templates"},{"$f":"'10.CTRA'!D4","v":"Standard templates for clinical research agreements and indemnities?"},{"$f":"'10.CTRA'!E4","v":"INPUT"},{"$f":"'10.CTRA'!F4","v":"A written agreement clarifying the obligations, responsibilities and rights of the parties involved in the trial is a requirement for the governance of the trial. Sponsor /CRO must be an Australian entity. Standard templates reduce the necessity for repetitive legal review."},{"$f":"'10.CTRA'!I4","v":0},{"$f":"'10.CTRA'!J4","v":0}]
[null,null,null,{"$f":"'10.CTRA'!E5","v":"INPUT"},null,{"$f":"'10.CTRA'!I5","v":0}]
[{"$f":"'10.CTRA'!A6","v":10.02},{"$f":"'10.CTRA'!$C$4","v":"Does your site utilize standard templates"},{"$f":"'10.CTRA'!D6","v":"Medicines Australia agreements for Clinical Trials of Investigational Products? "},{"$f":"'10.CTRA'!E6","v":"INPUT"},{"$f":"'10.CTRA'!F6","v":"Used when a pharmaceutical company is sponsoring a clinical trial."},{"$f":"'10.CTRA'!I6","v":0},{"$f":"'10.CTRA'!J6","v":0}]
[{"$f":"'10.CTRA'!A7","v":10.029999999999999},{"$f":"'10.CTRA'!$C$4","v":"Does your site utilize standard templates"},{"$f":"'10.CTRA'!D7","v":"Medical Technology Association of Australia (MTAA) for Clinical Investigations and Devices?"},{"$f":"'10.CTRA'!E7","v":"INPUT"},{"$f":"'10.CTRA'!F7","v":"Used when a medical device company is sponsoring a clinical trial."},{"$f":"'10.CTRA'!I7","v":0},{"$f":"'10.CTRA'!J7","v":0}]
[{"$f":"'10.CTRA'!A8","v":10.039999999999999},{"$f":"'10.CTRA'!$C$4","v":"Does your site utilize standard templates"},{"$f":"'10.CTRA'!D8","v":"Sponsor Specific Clauses for agreements with Public Health Institutions within NSW, QLD, VIC, SA and TAS Health Departments through the South Eastern Border States (SEBS Committee)?"},{"$f":"'10.CTRA'!E8","v":"INPUT"},{"$f":"'10.CTRA'!F8","v":"The Clinical Trial Research Agreement (CTRA) is designed to allow inclusion of sponsor specific clauses through the nominated Schedule; Schedule 4 for Standard Collaborative or Cooperative Research Groups CTRA and Schedule 7 for other CTRAs. "},{"$f":"'10.CTRA'!I8","v":0},{"$f":"'10.CTRA'!J8","v":0}]
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[{"$f":"'10.CTRA'!A10","v":10.049999999999999},{"$f":"'10.CTRA'!$C$4","v":"Does your site utilize standard templates"},{"$f":"'10.CTRA'!D10","v":"Is your site aware that all commercially sponsored research must include the Medicines Australia Standard Form of Indemnity or MTAA  Standard Form of Indemnity and that all commercially sponsored research must provide evidence of appropriate insurance?"},{"$f":"'10.CTRA'!E10","v":"INPUT"},{"$f":"'10.CTRA'!F10","v":"Indemnity is a contractual term to protect parties from specified actions, losses or claims. "},{"$f":"'10.CTRA'!I10","v":0},{"$f":"'10.CTRA'!J10","v":0}]
[null,null,null,{"$f":"'10.CTRA'!E11","v":"INPUT"},null,{"$f":"'10.CTRA'!I11","v":0}]
[{"$f":"'10.CTRA'!A12","v":10.059999999999999},{"$f":"'10.CTRA'!$C$4","v":"Does your site utilize standard templates"},{"$f":"'10.CTRA'!D12","v":"Service Level Agreements with third party vendors?"},{"$f":"'10.CTRA'!E12","v":"INPUT"},{"$f":"'10.CTRA'!F12","v":"Evidence of current insurance must be appropriate for the type of research."},{"$f":"'10.CTRA'!I12","v":0},{"$f":"'10.CTRA'!J12","v":0}]
[null,null,null,{"$f":"'10.CTRA'!E13","v":"INPUT"},null,{"$f":"'10.CTRA'!I13","v":0}]
[{"$f":"'10.CTRA'!A14","v":10.069999999999999},{"$f":"'10.CTRA'!$C$14","v":"Do you have a budget for your research?"},{"$f":"'10.CTRA'!D14","v":"Do you use a budgeting tool?"},{"$f":"'10.CTRA'!E14","v":"INPUT"},{"$f":"'10.CTRA'!F14","v":"A budgeting tool assists with contract negotiation and provides insight into the costs which will be incurrred during a specific clinical trial."},{"$f":"'10.CTRA'!I14","v":0},{"$f":"'10.CTRA'!J14","v":0}]
[null,null,null,{"$f":"'10.CTRA'!E15","v":"INPUT"},null,{"$f":"'10.CTRA'!I15","v":0}]
[{"$f":"'10.CTRA'!A16","v":10.079999999999998},{"$f":"'10.CTRA'!$C$14","v":"Do you have a budget for your research?"},{"$f":"'10.CTRA'!D16","v":"Do you use standard costs in your budgeting?"},{"$f":"'10.CTRA'!E16","v":"INPUT"},{"$f":"'10.CTRA'!F16","v":"The Independent Hospital Pricing Authority (IHPA) can be used as a guidance tool for the standard costs of conducting clinical trials in Australia.  "},{"$f":"'10.CTRA'!I16","v":0},{"$f":"'10.CTRA'!J16","v":0}]
[null,null,null,{"$f":"'10.CTRA'!E17","v":"INPUT"},null,{"$f":"'10.CTRA'!I17","v":0}]

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[]
["IP"]
["Device"]