Following approval, access is provided after the relevant study sponsor or sponsors receive a signed Data Sharing Agreement. This agreement includes requirements for the research team to:
- Only use the data for the agreed research purpose and not download or transfer the data.
- Protect the privacy and confidentiality of research participants; the researchers must not attempt to establish the individual identities of research participants.
- Obtain any regulatory or ethics approvals necessary to conduct the analysis.
- Notify sponsor of any replacement of Lead Researcher and/or Statistician as approved by the Independent Review Panel.
- Inform the relevant sponsor(s) and regulatory authorities of any safety concerns as soon as they are identified.
- Consent to the posting of the information contained in the Research Proposal (e.g. title, lay summary, requested clinical studies, the Lead Researcher’s name, affiliation, funding source and potential conflicts of interest ) on ClinicalStudyDataRequest.com after the Data Sharing Agreement has been signed.
- Publish the results of the analysis in a scientific journal within one year of analysis completion or for failed publications ensure that any analyses performed and associated outcomes are disclosed on an open access journal or publishing platform.
- Consent to the posting of a summary of the analysis plan, and a link to the publication citation or publically disclosed results (for failed publications) on ClinicalStudyDataRequest.com after the research is published.
- Provide the relevant sponsor(s) with a copy of any public disclosure of the results, including a copy of the manuscript. (Some sponsors include a provision for prior review of the manuscript; refer to the terms specified in Exhibit E of the actual Data Sharing Agreement.) Also provide the relevant sponsor(s) with the citation after publication.
- Acknowledge the relevant sponsor(s) and ClinicalStudyDataRequest.com in the publication.
- Allow the relevant sponsor(s) to use any invention coming out of the research that impacts the ability of the sponsor to develop or commercialise their products. Such use will be free of charge and throughout the world. If the sponsor requests additional rights, you agree to negotiate in good faith with the sponsor.
- Confirm that you do not have, and do not plan to have, any other agreements which would prevent you from complying with the above.
- Meet any additional requirements identified by the Independent Review Panel.
Note this is a legal document and so may require legal review within your organisation prior to signing.
The Data Sharing Agreement template is provided here. Your actual Data Sharing Agreement may have minor modifications.
Please note that the sponsors do not anticipate negotiation on the provisions in this template.