A signed Data Sharing Agreement (DSA) is required before data access can be provided.
Through the DSA you agree 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 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.
- Publish the results of the analysis in a scientific journal within one year of analysis completion. For failed publications, ensure that any analyses performed and associated outcomes are disclosed in an open access journal or publishing platform, with a link provided on ClinicalStudyDataRequest.com or provide the reason why the analysis was not performed for inclusion on ClinicalStudyDataRequest.com.
- Consent to the posting of the research proposal plan 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 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.
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.
If you are requesting data from a pharmaceutical company the Sponsor Data Sharing Agreement will be used.
Provision of Data
Following receipt of a signed Data Sharing Agreement (DSA), Researchers are provided access to anonymised patient-level data and supporting documentation in a secure data access system, known as the DESC for Clinical Data Sharing system. Providing data through this system further safeguards the privacy of patients and helps to ensure that a Researcher’s use of the data adheres to the provisions contained within the signed Data Sharing Agreement (DSA). Some Sponsors may provide data directly to Researchers where they are assured that the data will be secure - see the Sponsor specific pages for more information.
Access to data is provided for a 12-month period. Sponsors may extend access when justified for up to 24 months.
About the Clinical Trial Data Transparency (CTDT) System
The CTDT system is hosted by Dizzyatom and provides a secure research environment for Researchers to conduct their research.
Research teams are provided with a private research project area containing the anonymised patient level data and supporting documentation where they can create and run programs and store their outputs. This research project area is not accessed by Sponsors or other third parties unless Researchers request support. There are controls in place to prevent Researchers exporting the data and supporting documentation provided by a Sponsor. Researcher’s use of the data must adhere to the access and usage conditions required by Terms of Use.
Pre-installed Statistical Software
Through the "DESC Researcher Portal" or upon request
All fees, including licenses, for the pre-installed statistical software indicated above are paid by the Sponsors. The number of licenses for each Research Project may be limited to a maximum of five.
Support
Dizzyatom provides technical support to assist Researchers using the CTDT system.
User guides and instructional videos are provided on the DESC for Clinical Data Sharing.
In addition, some Sponsors provide support to assist Researchers in understanding the datasets provided. Further information can be found on the Sponsor specific pages.
Public disclosure of the research
After the Data Sharing Agreement is executed the title of the research proposal, name and affiliation of the lead researcher, research proposal summary, requested studies, funding source and potential conflicts of interest that are provided will be posted on this website. The publication citation and statistical analysis plan will be included after the research has been published.
The Data Sharing Agreement includes requirements to disclose the results of the Analysis in a scientific journal in a manner consistent with the research proposal publication plan. If for any reason the Analysis cannot be disclosed in a manner consistent with the publication plan, a brief summary of any activity performed, any outcome of the Analysis, and reason for non-completion, as applicable, should be disclosed in an open access journal or on a publishing platform with a link provided on this website.
All Publications are to acknowledge the appropriate Sponsor(s) and www.ClinicalStudyDataRequest.com as sources of data.
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