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What content and review process are expected for a Study Risk Determination Request?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

In addition to the general information that should be included in a cover letter for any Q-Sub type to ensure appropriate login and submission tracking, a Study Risk Determination Request should include the protocol for the proposed clinical study.

There is no Acceptance review for a Study Risk Determination request. Once a determination is made, FDA will issue a letter to the submitter indicating whether the study is exempt, or, if not exempt, is considered Significant Risk (SR) or Not Significant Risk (NSR). You may copy the letter to submit it to IRB(s) with the protocol. Once FDA has made a determination, the IRB does not need to conduct an independent assessment of risk; FDA’s determination is final.

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