Guidances > Draft Guidance Documents: Good Clinical Practice

Draft Guidance Documents: Good Clinical Practice

Draft guidance documents have been proposed and are issued for public comment. Each FDA draft document lists how to submit comments to the agency.
The entries below are listed in reverse chronological order by publication date.

• More information about draft GCP guidance documents¹

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Draft Guidance Documents

• Exculpatory Language in Informed Consent (PDF - 112KB) ²-08/2011
• Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 149KB) ³-08/2011
• Design Considerations for Pivotal Clinical Investigations for Medical Devices ⁴-08/2011
• Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review ⁵-08/2011
• In Vitro Companion Diagnostic Devices ⁶-07/2011
• Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions ⁷-06/2011
• Financial Disclosure by Clinical Investigators (PDF - 151KB) ⁸-05/2011
• Electronic Source Documentation in Clinical Investigations - Draft Guidance - 12/2010 (PDF - 166KB) ⁹-01/2011
• Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB) ¹⁰-10/2010
• Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies - Draft Guidance - 9/2010 (PDF - 687KB) ¹¹-09/2010
• IRB Continuing Review After Clinical Investigation Approval - Draft Guidance (PDF - 244KB) ¹²-01/2010
• In Vitro Diagnostic Multivariate Index Assays - Draft Guidance - 11/2006 ¹³-
• Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions - Draft Guidance (PDF - 34KB) ¹⁴-03/2002

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