Guidances > Clinical Trials Guidance Documents

Guidance for Industry and Investigators
Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Drug Safety
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http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM257976.pdf




Clinical Trials Guidance Documents

Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials. As with all guidance documents, they do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. However, in many places throughout these documents, specific regulations are cited and the requirements of the regulations are reiterated. The regulations are enforceable.

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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Draft Guidance Documents
Draft guidance documents have been proposed and are issued for public comment. Each FDA draft document lists how to submit comments to the agency.

Draft Guidance Documents: Good Clinical Practice1

open here to see/read and download the Clinical TRials Guidances:
Guidances > Clinical Trials Guidance Documents