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April 8, 20260 citationsOpen Access

Responsibilities for the Secondary Sharing of Clinical Trial Data in Australia (Data Sharing Governance Framework) - CT:IQ and ARDC Clinical Research Data Sharing Frameworks Project

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CCT:IQACAustralian Research Data Commons

Key Points

  • The aim is to provide a comprehensive governance framework for data sharing in clinical research within Australia.
  • Developed as a reference document for laws and regulations related to data sharing.
  • Created in collaboration with sector partners.
  • Designed to address specific technical and compliance issues.
  • Offers guidance for researchers and institutions on ethical and operational aspects of data sharing.
  • Addresses the responsibilities of data custodians and governance professionals.
  • Promotes responsible and effective sharing of clinical research data in Australia.

Abstract

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 custodians About the project: 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. Acknowledgement Clinical Research Data Sharing Frameworks is a co-investment partnership with the Australian Research Data Commons (ARDC) through the People Research Data Commons (DOI: 10.3565/655K-7H05). The ARDC is enabled by the Australian Government’s National Collaborative Research Infrastructure Strategy (NCRIS).

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Cite This Study

CT:IQ et al. (2026) studied this question.

synapsesocial.com/papers/69d5f0bb74eaea4b11a7a194https://doi.org/10.5281/zenodo.19446112
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