Clinical Trials--Information for Health Professionals


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		Report to FDA: Complaints relating to clinical trials Mandatory IRB Reporting: FDA Contacts Clinical Trial Forms Good Clinical Practice Program Approved Products drugs, medical devices, biologicals, animal drugs, food additives ... Freedom of Information Dockets Management FDA Site Map				Regulations Good Clinical Practice/Clinical Trials Regulations Preambles to GCP Regulations Laws Enforced by FDA Guidances, Information Sheets, and Notices Current guidance and notices on good clinical practice and the conduct of clinical trials. Proposed Regulations and Draft Guidances Details about these proposals and instructions for submitting comments. Enforcement Information Warning letters, disqualification proceedings, restricted list, adequate assurances list ... Bioresearch Monitoring Program Links to relevant Compliance Program Guidance Manuals and Bioresearch monitoring inspection metrics. Educational Materials Useful literature references, and training information about good clinical practices. GCPP E-Mail Replies Redacted GCPP E-mail replies to inquiries that have been submitted by the public to the Good Clinical Practice Program's gcp.questions@fda.hhs.gov E-mail account.			In the News Final Guidance for CIs, Sponsors, and IRBs on Adverse Events Reporting to IRBs publishes Final rule on IRB Registration requirements publishes [PDF] FDA Announces Guidance on Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials International Compilation of HSP laws/regulations for 2009 Draft Guidance on 1572 FAQs available for comment Disqualification of a Clinical Investigator: Hearing Process FDA announces availability of documents from the Global Harmonization Task Force (GHTF) (pdf version, 381KB) Workshops & Meetings Conferences on FDA clinical trial requirements Additional Information Contact Us IND/IDE Contact Information Related Websites PDF documents may be read with a free copy of the Adobe Acrobat Reader.

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