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.
Draft Guidance Documents
Draft guidance documents have been proposed and are issued for public comment.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.
Some Web links (URLs) embedded within guidance documents may have changed since the document was published. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
General Information Sheet Guidance
- Charging for Investigational Products - Information Sheet -01/1998
- Cooperative Research - Information Sheet -01/1998
- Informed Consent, A Guide to - Information Sheet - 01/1998
- Institutional Review Boards Frequently Asked Questions - Information Sheet - 01/1998
- Non-local IRB Review - Information Sheet 01/1998
- "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices - Information Sheet - 01/1998
- Payment and Reimbursement to Research Subjects - Information Sheet - 01/2018
- Recruiting Study Subjects - Information Sheet - 01/1998
- Screening Tests Prior to Study Enrollment - Information Sheet - 01/1998
- Sponsor - Investigator - IRB Interrelationship - Information Sheet - 01/1998
- Use of Investigational Products When Subjects Enter a Second Institution - Information Sheet - 01/1998
Drugs and Biologics Information Sheet Guidance
- Drug Study Designs - Information Sheet - 01/1998
- Emergency Use of an Investigational Drug or Biologic - Information Sheet - 01/1998
- Evaluation of Gender Differences in Clinical Investigations - Information Sheet - 01/1998
- Statement of Investigator (Form FDA 1572) - Frequently Asked Questions - Information Sheet - 05/2010
- Treatment Use of Investigational Drugs - Information Sheet - 01/1998
- Waiver of IRB Requirements for Drug and Biological Product Studies - Information Sheet -10/2017
Medical Devices Information Sheet Guidance
- Medical Devices, Frequently Asked Questions About - Information Sheet - 01/2006
- Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet - 01/2006
FDA Operations Information Sheet Guidance
- Clinical Investigator Administrative Actions - Disqualification - 03/2014
- FDA Inspections of Clinical Investigators - Information Sheet - 06/2010
- FDA Institutional Review Board Inspections - Information Sheet - 10/2006
General Guidance Documents
- 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations, Process for Handling Referrals to FDA Under - 12/2006
- Clinical Holds, Submitting and Reviewing Complete Responses to - 10/2000
- Clinical Lactation Studies - Study Design, Data Analysis, and Recommendations for Labeling -02/2005
- Data Monitoring Committees for Clinical Trial Sponsors, The Establishment and Operation of Clinical Trial - 03/2006
- Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - 10/2008
- Exception from Informed Consent Requirements for Emergency Research - 04/2013
- Financial Disclosure by Clinical Investigators - 02/2013
- Financial Relationships and Interests in Research Involving Human Subjects -05/2004
- Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations - 10/2018
- Independent Consultants for Biotechnology Clinical Trial Protocols - 08/2004
- Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects - 10/2009
- Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring - 08/2013
- Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (final) - 12/2009
- Pharmacogenomic Data Submissions 03/2005
- Race and Ethnicity Data in Clinical Trials, Collection of - 10/2016
Institutional Review Boards (IRBs) and Informed Consent Guidance Documents
- Adverse Event Reporting to IRBs - Improving Human Subject Protection - 01/2009
- Centralized IRB Review Process in Multicenter Clinical Trials, Using a - 03/2006
- Considerations When Transferring Clinical Investigation Oversight to Another IRB - 05/2014
- HIPAA Authorizations Under FDA Regulations, IRB Review of Stand-Alone - 10/2003
- Informed Consent Elements, 21 CFR 50.25(c), Questions and Answers - 02/2012
- Institutional Review Board (IRB) Written Procedures - 05/2018
- IRB Continuing Review After Clinical Investigation Approval - 02/2012
- IRB Registration, Frequently Asked Questions - 07/2009
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed - 08/2013
- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects - 07/2017
- Minutes of Institutional Review Board (IRB) Meetings - Guidance for Institutions and IRBs - 09/2017
Drugs and Biologics Guidance Documents
- Bioavailability and Bioequivalence Testing Samples, Handling and Retention of - 08/2004
- Charging for Investigational Drugs Under an IND — Qs & As -06/2016
- Clinical Holds Following Clinical Investigator Misconduct, The Use of - 09/2004
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format - 01/2006
- Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products -03/2019
- Expanded Access to Investigational Drugs for Treatment Use — Qs & As -10/2017
- Exploratory IND Studies - 01/2006
- FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions - 03/2012
- Food-Effect Bioavailability and Fed Bioequivalence Studies - 12/2002
- Gender Differences in the Clinical Evaluation of Drugs, Guideline for the Study and Evaluation of - 07/1993
- Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment - 03/2005
- IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer - 01/2004
- Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND - 09/2013
- Premarketing Risk Assessment - 03/2005
- Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications - 01/2019
- Risk Minimization Action Plans, Development and Use of - 03/2005
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies - 12/2012
- Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide - 12/2012
Medical Devices Guidance Documents
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions - 02/2018
- Analyte Specific Reagents (ASRs), Commercially Distributed: Frequently Asked Questions - 09/2007
- Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only -11/2013
- Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies - 09/2017
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications - 08/2016
- Humanitarian Device Exemption (HDE) Program - 08/2019
- Humanitarian Use Device (HUD) Designations - 01/2013
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - 04/2006
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions - 06/2010
- General Principles of Software Validation - 01/2002
Electronic Data Guidance Documents
- Computerized Systems Used in Clinical Investigations - 05/2007
- Electronic Informed Consent in Clinical Investigations, use of - Questions and Answers - 12/2016
- Electronic Source Data in Clinical Investigations - 09/2013
- Part 11, Electronic Records; Electronic Signatures - Scope and Application - 08/2003
Manufacturing Requirements for Investigational Products Guidance Documents
- Current Good Manufacturing Practice for Phase 1 Investigational Drugs - 07/2008
- Design Control Guidance For Medical Device Manufacturers - 03/1997
- INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information - 05/2003
Resources For You
- Clinical Trials and Human Subject Protection
- About GCP Guidance Documents (Including Information Sheets) and Notices
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
- Selected FDA GCP/Clinical Trial Guidance Documents
- ICH Guidance Documents Related to Good Clinical Practice
- Proposed GCP Regulations and Draft Guidances
- GCP/Clnical Trial Notices