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What documentation should the sponsor or applicant provide regarding investigator qualifications?
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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.

FDA requires documentation to show that the investigator is qualified to serve as a study investigator based on their training and experience specifically related to the proposed clinical investigation. Such documentation generally includes a curriculum vitae or summary of training. If this information is already included as part of the Clinical Study Reports (CSR), referencing the appropriate section within the CSR is acceptable. For research involving novel technologies and/or the potential for increased risk of morbidity and/or mortality, the sponsor or applicant may wish to include additional documentation identifying the clinical investigator’s specific experience in this field (e.g., as demonstrated by recent presentations or publications) and with the test article.

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