How It Works

Data Sharing Agreement

A signed Data Sharing Agreement (DSA) is required before data access can be provided.

Through the DSA you agree to:

  1. Only use the data for the agreed research purpose and not download or transfer the data.
  2. Protect the privacy and confidentiality of research participants; the researchers must not attempt to establish the individual identities of research participants.
  3. Obtain any regulatory or ethics approvals necessary to conduct the analysis.
  4. Notify sponsor of any replacement of Lead Researcher and/or Statistician as approved by the Independent Review Panel.
  5. Inform the relevant sponsor(s) and regulatory authorities of any safety concerns as soon as they are identified.
  6. Consent to the posting of the title, research proposal summary, requested clinical studies, the Lead Researcher’s name, affiliation, funding source and potential conflicts of interest(as provided on the Research Proposal Form) on ClinicalStudyDataRequest.com, after the Data Sharing Agreement has been signed.
  7. 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, with a link provided on ClinicalStudyDataRequest.com.
  8. Consent to the posting of the research proposal plan on ClinicalStudyDataRequest.com, after the research is published.
  9. 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 sponsor(s) with the citation after publication.
  10. Acknowledge the relevant sponsor(s) and ClinicalStudyDataRequest.com in the publication.
  11. 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.
  12. Confirm that you do not have, and do not plan to have, any other agreements which would prevent you from complying with the above.

After approval from the Independent Review Panel, a DSA will be issued by the Sponsor(s) based on the templates provided below.

Your actual DSA may have minor modifications. For example, for a Research Proposal involving multiple Sponsors another DSA similar to the template provided below will be used.

Please note that the Sponsor(s) do not anticipate negotiation on the DSA provisions and it is recommended that the research institution's contracting representatives understand the overall nature of the Research Proposal and conduct an early review of the DSA provisions included in the template(s) provided below, before the actual DSA is issued. Delays due to negotiation will delay data access.

Link to Sponsor Data Sharing Agreement   |   Link to Academic Sponsor Data Sharing Agreement