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  1. Clinical Trials and Human Subject Protection

Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors

Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors

Background

Guidance documents included under the umbrella title of FDA Information Sheets represent the agency's current thinking on protection of human subjects in research. The date following the title of each document represents the most recent update for that subject. Many documents were last updated prior to the enactment of good guidance practice requirements. As further updates become necessary, reformatting of some documents may therefore be necessary. While most will still be included under the umbrella of Information Sheets, some may be accessible separately after update.

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