The CT:IQ and ARDC Clinical Research Data Sharing Frameworks Project supports the responsible and effective sharing of clinical research data in Australia. These resources have been developed in collaboration with sector partners to guide researchers, institutions, ethics review bodies and others in navigating the ethical, governance, and operational considerations of data sharing.
How to use these resources
The toolkit below provides a structured approach to understanding and implementing best practice in clinical research data sharing.
1. Data Sharing Toolkit
This resource provides high-level information and guidance on the key principles and considerations for data sharing governance. This is designed to help researchers and others involved in data sharing understand their responsibilities and opportunities within the evolving research landscape.
Recommended for: All researchers and research organisations engaged in clinical trials or secondary data analysis.
2. Ethics Submission and Review Guide
The Ethics Submission and Review Guide offers more detailed guidance for researchers preparing to submit a data sharing project to an ethics review body including a Human Research Ethics Committee (HREC). It supports both researchers and ethics review body members in understanding the ethical considerations specific to data sharing, including the application of the National Statement on Ethical Conduct in Human Research.
This guide complements the findings of the Ethics Review Body Benchmarking Exercise Report, which identified areas of variation across ethics review bodies and informed the development of this resource.
Recommended for: Researchers submitting data sharing projects for ethics review and members of ethics review bodies.
3. Responsibilities for the Secondary Sharing of Clinical Trial Data in Australia (Data Sharing Governance Framework)
The Governance Framework serves as a comprehensive reference document for those seeking detailed information about relevant laws, regulations, and governance structures that underpin data sharing in Australia. It is designed to be used on an as-needed basis to address specific technical or compliance issues related to data governance.
Recommended for: Research governance professionals, data
4. Data Glossary
The Data Glossary includes definitions of key data sharing terms used in the CT:IQ and ARDC Clinical Research Data Sharing Frameworks Project.
Recommended for: All users of the CT:IQ and ARDC Clinical Research Data Sharing Frameworks Project.
