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Upon submission, the request will be received by the Clinical Research Informatics (CRI) / Health Data Innovation Program (HDIP) team. An initial response acknowledging receipt of the request will be provided within 1-2 business days.
The Research Informatics team will subsequently Subsequently, CRI/HDIP staff will schedule a consultation to discuss the specifics of the request and to obtain any necessary approval documentation.
The CRI team will review the request details and ensure alignment with the IRB approval. During the review process, the CRI team will verify the IRB documentation, including (as applicable):
Letter of Approval
Research Methodology
Approved Personnel
HIPAA Waivers
Data Transfer Mechanism
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Approved data elements for transfer
Transfer mechanism compliance, including review and approval by Keck Information Security
If an unapproved transfer method is indicated, a security review may be required. In some cases, a Data Use Agreement (DUA) will need to must be executed to ensure compliance.
Time and Cost
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Estimate
Upon verification of all required approvals, the CRI team will provide an estimate of time and cost associated with the data extraction. Following approval of the estimate by the research team, data extraction will be conducted. The data will be delivered to the designated research PACS system or through the IRB-approved transfer method.
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Request timelines vary based on the following factors:
Volume The volume of requests in the queue
Complexity of the request
Timeliness of the research team’s response to estimates, follow-up questions, or additional documentation requests
Additional requirements, such as a DUA, Data Transfer Agreement (DTA), or Information Security approval, may significantly extend the timeline for completion.
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