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                Clinical Trials and Human Subject Protection

Clinical Trials and Human Subject Protection

                        BIMO Inspection Metrics
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          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


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          Clinical Trials and Human Subject Protection
          Clinical Trial FormsClinical Trials and Human Subject Protection Clinical Trial Forms
  
  	
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    PrintThis page provides links to commonly used clinical trial forms relevant to clinical trials.

FDA 1571 (PDF - 2MB)
	Investigational New Drug ApplicationInstructions for completing Form FDA 1571
	FDA 1572 (PDF - 1.4MB)
	Statement of InvestigatorInstructions for completing Form FDA 1572FDA 3454 (PDF - 673KB)Certification: Financial Interest and Arrangements of Clinical Investigator
	FDA 3455 (PDF - 673KB)Disclosure: Financial Interest and Arrangements of Clinical Investigators
	FDA 3674 (PDF 2.6MB)Certification of Compliance Under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (includes instructions)For other FDA forms, visit the FDA Forms page.

                                                                                  Content current as of:
      03/07/2022Clinical Trials and Human Subject Protection

          
                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries
 
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