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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
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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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