CT:IQ’s Clinical Research Data Sharing Projects aim to support 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, and ethics review bodies in navigating the ethical, governance, and operational considerations of data sharing.
Together, these documents provide a practical framework to promote transparency, reproducibility, and trust in clinical research.
How to use these resources
The toolkit below provides a structured approach to understanding and implementing best practice in clinical research data sharing. Each resource is designed for a different stage of the research and ethics review process.
1. Data Sharing Toolkit
This resource provides high-level information and guidance for all clinical trialists and secondary researchers. It outlines key principles, considerations, and steps involved in data sharing, helping you understand your 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 Guide
The Ethics Submission Guide offers more detailed guidance for researchers preparing to submit a data sharing project to an ethics review body. It supports both researchers and ethics committee members in understanding the ethical considerations specific to data sharing, including consent, privacy, and data access.
This guide complements the findings of CT:IQ’s 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. Data Sharing Governance Framework
The Governance Framework serves as a comprehensive reference document—or “bible”—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, institutional data custodians, legal advisors, and anyone requiring detailed regulatory guidance.
Key resources
- Data sharing toolkit
- Ethics submission guide
- Governance framework
- Watch: Overview of secondary data sharing