This diagram outlines the process by which the YODA Project reviews and processes data requests, the components of which are discussed in greater detail below.
- YODA Project Review: All requests for data will undergo review upon receipt by the YODA Project. During this review, the YODA Project will evaluate submitted requests and associated registration materials to ensure that all required information has been provided and that the Research Proposal has scientific merit. Refer to the YODA Project Data Release Policies and Procedures (Section 3) for further information.
- The YODA Project will contact the requestor if additional information or clarification of the data request is needed.
- Due Diligence Assessment: Requests for data that are not already available in the secure data sharing platform will undergo a Due Diligence Assessment by the Data Holder. Refer to the YODA Project Data Release Policies and Procedures (Section 4) for further information.
- External Review: Requests will undergo External Review if the YODA Project is unable to verify the scientific merit of the Research Proposal. Refer to the YODA Project Data Release Policies and Procedures (Section 5) for further information.
- The YODA Project will contact the requestor when a decision is made regarding data access.
- The requestor will be required to sign and submit a Data Use Agreement.
- Depending on the Data Holder, data will be made available either via a password-protected personalized account on a secure data sharing platform or via the Yale Secure File Transfer Service. Refer to the YODA Project Data Release Policies and Procedures (Section 7) for further information.
Timeline for Review
The YODA Project aims to provide access to data for approved data requests as quickly as possible. The timeline for data request review and data access is broken down as follows:
- The YODA Project estimates that a decision to grant or deny data access will be made within 30 days of receipt of the complete data request. This time period may be affected by the number of trials requested, the need for External Review of the Research Proposal, and/or the number of requests received overall.
- The goal is to provide access to data within 30 days of the YODA Project’s receipt of the researcher’s signed Data Use Agreement. The requestor will be notified if this timeline will be longer than anticipated.
Transparency and the Public Posting of Requests
The YODA Project will publicly post all data requests and associated registration materials, including Research Proposals, summaries of the Data Holder’s Due Diligence Assessment, any External Reviews, and the YODA Project’s decision to grant or deny data access. If access is denied, a public report detailing the reasons will be provided. Public posting is intended to promote transparency of clinical research and public accountability of the YODA Project data release process.