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Guidance Documents/Guidance-Document/Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards

Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

October 11, 2018

July 18, 2019

Office of the Commissioner

1422bcc4-3c75-42a9-8d4e-3fae4c517eaf

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