FREQUENTLY Asked Questions
Would a study report “Synopsis” provide a sufficiently detailed summary of the protocol and study results for FDA acceptance of foreign clinical studies not conducted under an IND?
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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.

No, submitting only the Synopsis from Annex I of ICH E3 would not be adequate to meet the requirement in 21 CFR 312.120(b)(3), because the Synopsis would not provide sufficient detail about the study protocol or results. By contrast, submitting an integrated, full Clinical Study Report (CSR) in accordance with ICH E3 would meet this requirement, although alternative approaches are also acceptable. Integrated, full CSRs are commonly submitted for clinical and human pharmacology investigations that contribute to the evaluation of effectiveness for the proposed indication or that otherwise support information included in proposed labeling for the product. Sponsors and applicants are reminded that, even if they submit such integrated, full CSRs, they must also submit any additional information that is required by 21 CFR parts 312, 314, or 601.

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