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Clinical Trials Guidance Documents

Guidance documents accessible from this page represent the Agency's current thinking on the conduct of clinical trials/good clinical practice (GCP) and human subject protection (HSP). The term ‘guidance’ includes documents issued as ‘FDA information sheets.’

Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. Guidance should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. The use of the word “should” in agency guidance means that something is suggested or recommended, but not required.

Note that some Web links (URLs) embedded within guidance documents may have changed since the date a document was published. If you find a link that does not work, please try searching for the document using the document title on the Search for FDA Guidances page, or go to Contact FDA for assistance. You may also report broken links related to guidance about good clinical practice and human subject protection to gcp.questions@fda.hhs.gov.


Guidance Title Topic Draft or Final Date Issued
Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for 
IND and Bioavailability/Bioequivalence Studies Guidance for Industry
Drug Safty Draft 6/25/2021
Certificates of Confidentiality HIPAA, Human Subject Protection (HSP), Investigation Final 11/16/2020
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Design, Diversity, Ethics Committee (EC), Ethnicity, Gender, Good Clinical Practice (GCP), Human Subject Protection (HSP) Final 11/10/2020
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Civil Money Penalties, clinicaltrials.gov Final 08/14/2020
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format Design, Investigation, Labeling, Lactation, Pregnancy, Sponsor Draft 07/29/2020
Conduct of Clinical Trials of Medical Products during COVID—19 Public Health Emergency Coronavirus, COVID, Good Clinical Practice (GCP), Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB), Investigation Final 07/02/2020
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry Electronic, Investigational New Drug (IND), Part 11, Records Final 02/21/2020
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Design, Good Clinical Practice (GCP), Investigation, Sponsor Draft 12/20/2019
Adaptive Design Clinical Trials for Drugs and Biologics Clinical — Medical, Design, Good Clinical Practice (GCP), Investigation, Sponsor Final 12/02/2019
Humanitarian Device Exemption (HDE) Program Exemption, Humanitarian Device Exemption (HDE), Humanitarian Use Device (HUD), Medical Device Final 09/06/2019
Humanitarian Use Device (HUD) Designations Exemption, Humanitarian Device Exemption (HDE), Humanitarian Use Device (HUD), Medical Device Final 09/05/2019
ICH E8(R1): General Considerations for Clinical Studies Ethics Committee (EC), Good Clinical Practice (GCP), Human Subject Protection (HSP), Institutional Review Board (IRB), International Conference on Harmonization (ICH), Records, Sponsor Draft 08/01/2019
Clinical Lactation Studies: Considerations for Study Design Design, Investigation, Lactation, Sponsor Draft 05/09/2019
Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers Good Clinical Practice (GCP) Draft 03/15/2019
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products Clinical, Design, Efficacy, Variability, Protocol, Exclusion, Inclusion, Genomic Final 03/15/2019
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials Children, Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB), Pediatric Final 03/13/2019
Impact of Certain Provisions of the Revised Common Rule on FDA—Regulated Clinical Investigations Common Rule, Human Subject Protection (HSP), Institutional Review Board (IRB) Final 10/11/2018
ICH E17: General Principles for Planning and Design of Multi—Regional Clinical Trials Design, Ethics Committee (EC), Good Clinical Practice (GCP), Human Subject Protection (HSP), Institutional Review Board (IRB), International Conference on Harmonization (ICH), Records, Sponsor Final 07/19/2018
Institutional Review Board (IRB) Written Procedures Institutional Review Board (IRB), Records Final 05/17/2018
ICH E11(R1): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population Children, Ethics Committee (EC), Good Clinical Practice (GCP), Human Subject Protection (HSP), Institutional Review Board (IRB), International Conference on Harmonization (ICH), Records, Sponsor Final 04/11/2018
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Gender, Human Subject Protection (HSP), Institutional Review Board (IRB), Investigation, Pregnancy Draft 04/09/2018
ICH E6(R2): Good Clinical Practice: Integrated Addendum to ICH E6(R1) Ethics Committee (EC), Good Clinical Practice (GCP), Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB), Sponsor Final 03/01/2018
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions Good Clinical Practice (GCP), Investigation, Investigational Device Exemption (IDE), Medical Device Final 02/21/2018
Payment and Reimbursement to Research Subjects Human Subject Protection (HSP), Informed Consent Final 01/29/2018
Investigational IVDs Used in Clinical Investigations of Therapeutic Products Good Clinical Practice (GCP), In Vitro Diagnostic (IVD), Investigation, Investigational Device Exemption (IDE), Investigational New Drug (IND), Labeling, Medical Device, Sponsor Draft 12/18/2017
Waiver of IRB Requirements for Drug and Biological Product Studies Human Subject Protection (HSP), Institutional Review Board (IRB), Waiver Final 10/03/2017
Individual Patient Expanded Access Applications: Form FDA 3926 Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB), Investigation, Investigational New Drug (IND) Final 10/03/2017
Minutes of Institutional Review Board (IRB) Meetings Institutional Review Board (IRB), Records Final 09/25/2017
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies Demographic, Diversity, Ethnicity, Gender, Investigation, Medical Device, Pediatric Final 09/12/2017
IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB), Waiver Final 07/25/2017
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Good Clinical Practice (GCP), Human Subject Protection (HSP), Electronic, Investigation, Part 11, Records Draft 06/21/2017
Form FDA 3674 — Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions Certify, Certification, clinicaltrials.gov, Medical Device Final 06/07/2017
Emergency Use Authorization of Medical Products and Related Authorities Emergency, Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB), Investigation, Investigational New Drug (IND) Final 01/13/2017
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers Electronic, Good Clinical Practice (GCP), Human Subject Protection (HSP), Informed Consent, Part 11, Records Final 12/15/2016
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes Advisory Committees, Clinical — Medical, Good Clinical Practice (GCP), Humanitarian Device Exemption (HDE), Humanitarian Use Device (HUD), Labeling, Laser Notice, Medical Device, Neurological, Premarket, Premarket Approval (PMA), Safety, Sponsor Final 11/07/2016
Collection of Race and Ethnicity Data in Clinical Trials Demographic, Ethnicity, Race Final 10/26/2016
Adaptive Designs for Medical Device Clinical Studies Good Clinical Practice (GCP), Humanitarian Device Exemption (HDE), Humanitarian Use Device (HUD), Investigational Device Exemption (IDE), Medical Device, Premarket, Premarket Approval (PMA), Sponsor, 510k Final 07/27/2016
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information Chemistry Manufacturing Controls (CMC), Good Clinical Practice (GCP), Investigation, Sponsor Final 06/30/2016
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices Children, Human Subject Protection (HSP), Medical Device Final 06/21/2016
Charging for Investigational Drugs Under an IND — Questions and Answers Good Clinical Practice (GCP), Investigation, Investigational New Drug (IND) Final 06/03/2016
Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB), Investigation, Investigational New Drug (IND) Final 06/03/2016
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails Good Clinical Practice (GCP), Humanitarian Device Exemption (HDE), Humanitarian Use Device (HUD), Investigational Device Exemption (IDE), Medical Device, Premarket, Premarket Approval (PMA), Sponsor, 510k Final 03/07/2016
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) Design, Investigation, Labeling, Lactation, Pregnancy, Sponsor Final 06/10/2015
Informed Consent Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB) Draft 09/15/2014
Evaluation of Sex-Specific Data in Medical Device Clinical Studies Demographic, Design, Gender, Good Clinical Practice (GCP), Medical Device, Premarket, Sponsor Final 08/22/2014
Considerations When Transferring Clinical Investigation Oversight to Another IRB Institutional Review Board (IRB) Final 05/23/2014
Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v. Windsor: Questions and Answers Informed Consent, Institutional Review Board (IRB) Final 03/31/2014
Clinical Investigator Administrative Actions — Disqualification Disqualification, Good Clinical Practice (GCP), Human Subject Protection (HSP), Investigator, Inspection Final 03/01/2014
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only In Vitro, Investigation, Medical Device, Specimen Final 11/25/2013
Design Considerations for Pivotal Clinical Investigations for Medical Devices Design, Good Clinical Practice (GCP), Investigation, Medical Device, Premarket, Sponsor Final 11/07/2013
Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies Institutional Review Board (IRB), Investigation, Medical Device, Safety Final 10/01/2013
Electronic Source Data in Clinical Investigations Good Clinical Practice (GCP), Electronic, Part 11, Records Final 09/18/2013
Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND Institutional Review Board (IRB), Investigation, Investigational New Drug (IND) Final 09/10/2013
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed Institutional Review Board (IRB), Investigational Device Exemption (IDE), Investigational New Drug (IND), Investigator, Medical Device Final 08/27/2013
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Good Clinical Practice (GCP) Final 08/07/2013
Exception from Informed Consent Requirements for Emergency Research Good Clinical Practice (GCP), Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB) Final 04/01/2013
Financial Disclosure by Clinical Investigators Financial Disclosure, Good Clinical Practice (GCP) Final 02/01/2013
ICH E3: Structure and Content of Clinical Study Reports, Questions and Answers Good Clinical Practice (GCP), International Conference on Harmonization (ICH), Sponsor Final 01/29/2013
Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies Bioavailability, Bioequivalence, Good Clinical Practice (GCP), Investigation, Investigational New Drug (IND), Safety Final 12/20/2012
Safety Reporting Requirements for INDs and Bioavalability/Bioequivalence (BA/BE) Studies — Small Entity Compliance Guide Bioavailability, Bioequivalence, Good Clinical Practice (GCP), Investigation, Investigational New Drug (IND), Safety Final 12/20/2012
FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions Good Clinical Practice (GCP), Investigation, Investigational New Drug (IND) Final 03/01/2012
ICH E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers Design, Diversity, Ethnicity, Gender, International Conference on Harmonization (ICH), Sponsor Final 03/01/2012
IRB Continuing Review After Clinical Investigation Approval Continuing Review, Institutional Review Board (IRB) Final 02/27/2012
Informed Consent Elements, 21 CFR § 50.25(c), Questions and Answers Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB) Final 02/01/2012
Exculpatory Language in Informed Consent Good Clinical Practice (GCP), Human Subject Protection (HSP), Informed Consent Draft 08/19/2011
Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application Institutional Review Board (IRB), Investigational New Drug (IND) Final 08/02/2010
In Vitro Diagnostic (IVD) Device Studies — Frequently Asked Questions Human Subject Protection (HSP), In Vitro, Informed Consent, Medical Device, Specimen Final 06/25/2010
Statement of Investigator (Form FDA 1572) Frequently Asked Questions Good Clinical Practice (GCP), Human Subject Protection (HSP), Investigator, 1572 Final 06/04/2010
FDA Inspections of Clinical Investigators Good Clinical Practice (GCP), Human Subject Protection (HSP), Inspection, Investigator Final 06/01/2010
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Investigation, Investigational New Drug (IND), Product Development Final 12/09/2009
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Clinical Investigator, Institutional Review Board (IRB) Final 10/23/2009
IRB Registration — Frequently Asked Questions Institutional Review Board (IRB), Registration Final 07/09/2009
Adverse Event Reporting to IRBs — Improving Human Subject Protection Institutional Review Board (IRB), Report, Safety Final 01/14/2009
Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices Drug, Labeling, Practice, Medical Device, Medicine, Sponsor Final 12/31/2008
Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials Good Clinical Practice (GCP), Human Subject Protection (HSP), Informed Consent Final 10/01/2008
Current Good Manufacturing Practice for Phase 1 Investigational Drugs Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Investigation Final 07/14/2008
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions In Vitro Diagnostic (IVD), Laboratory Developed Test (LDT), Medical Device, Reagent Final 09/13/2007
Computerized Systems Used in Clinical Investigations Good Clinical Practice (GCP), Electronic, Part 11, Records Final 05/10/2007
Process for Handling Referrals to FDA Under 21 CFR 50.54 — Additional Safeguards for Children in Clinical Investigations Children, Human Subject Protection (HSP), Informed Consent, Institutional Review BA/BEoard (IRB), Pediatric Final 12/01/2006
ICH E5 Ethnic Factors in the Acceptability of Foreign Clinical Data, Questions and Answers Design, Diversity, Ethics Committee (EC), Ethnicity, Gender, Human Subject Protection (HSP), Institutional Review Board (IRB), International Conference on Harmonization (ICH), Sponsor Final 09/01/2006
Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable Human Subject Protection (HSP), In Vitro, Informed Consent, Medical Device, Specimen Final 04/25/2006
Establishment and Operation of Clinical Trial Data Monitoring Committees Good Clinical Practice (GCP), Human Subject Protection (HSP), Institutional Review Board (IRB) Final 03/28/2006
Using a Centralized IRB Review Process in Multicenter Clinical Trials Institutional Review Board (IRB), Multi—center, Single Final 03/16/2006
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Investigation, Labeling, Sponsor Final 01/24/2006
Exploratory IND Studies Good Clinical Practice (GCP), Investigation, Investigational New Drug (IND) Final 01/12/2006
Medical Devices — Frequently Asked Questions Institutional Review Board (IRB), Medical Device, Risk, Safety Final 01/01/2006
Significant Risk and Nonsignificant Risk Medical Device Studies Institutional Review Board (IRB), Medical Device, Risk, Safety Final 01/01/2006
FDA Institutional Review Board Inspections Human Subject Protection (HSP), Institutional Review Board (IRB), Inspection Final 01/01/2006
Premarketing Risk Assessment Good Clinical Practice (GCP), Investigational New Drug (IND), Risk, Safety Final 03/29/2005
Development and Use of Risk Minimization Action Plans Informed Consent, Risk, Safety, Sponsor Final 03/29/2005
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Clinical — Medical, Good Clinical Practice (GCP) Final 03/24/2005
Pharmacogenomic Data Submissions Pharmacogenomic, Product Development Final 03/23/2005
Use of Clinical Holds Following Clinical Investigator Misconduct Good Clinical Practice (GCP), Hold, Investigation, Investigational New Drug (IND), Investigator, Misconduct Final 09/02/2004
Independent Consultants for Biotechnology Clinical Trial Protocols Biotechnology, Clinical Trial, Protocol Final 08/19/2004
Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples Bioavailability, Bioequivalence Final 05/25/2004
Financial Conflict of Interest: HHS Guidance (2004) Financial Disclosure, Good Clinical Practice (GCP), Institutional Review Board (IRB) Final 05/05/2004
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer Exemption, Good Clinical Practice (GCP), Investigation, Investigational New Drug (IND) Final 01/15/2004
Part 11, Electronic Records; Electronic Signatures — Scope and Application Electronic, Good Clinical Practice (GCP), Part 11, Records Final 09/05/2003
IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations HIPAA, Institutional Review Board (IRB) Final 08/16/2003
INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information Chemistry Manufacturing Controls (CMC), Investigation, Investigational New Drug (IND), Sponsor Final 05/20/2003
Food-Effect Bioavailability and Fed Bioequivalence Studies Bioavailability, Bioequivalence, Drug, Food, Investigational New Drug (IND) Final 12/01/2002
General Principles of Software Validation Electronic, Investigation, Medical Device, Part 11, Quality, Risk, Software, Validation Final 01/11/2002
ICH E10: Choice of Control Group and Related Issues in Clinical Trials Design, Ethics Committee (EC), Good Clinical Practice (GCP), Human Subject Protection (HSP), Institutional Review Board (IRB), International Conference on Harmonization (ICH), Records, Sponsor Final 05/14/2001
ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population Children, Ethics Committee (EC), Good Clinical Practice (GCP), Human Subject Protection (HSP), Institutional Review Board (IRB), International Conference on Harmonization (ICH), Records, Sponsor Final 12/15/2000
Clinical Holds — Submitting and Reviewing Complete Responses Good Clinical Practice (GCP), Hold, Investigation, Investigational New Drug (IND), Investigator Final 10/01/2000
Categories of Research That May Be Reviewed Through an Expedited Review Process Expedited Review, Good Clinical Practice (GCP), Human Subject Protection (HSP), Institutional Review Board (IRB) Final 11/09/1998
ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data Design, Diversity, Ethics Committee (EC), Ethnicity, Gender, International Conference on Harmonization (ICH), Sponsor Final 06/10/1998
Evaluation of Gender Differences in Clinical Investigations Demographic, Gender, Good Clinical Practice (GCP), Human Subject Protection (HSP), Investigation, Investigational New Drug (IND) Final 01/01/1998
Institutional Review Boards Frequently Asked Questions Human Subject Protection (HSP), Institutional Review Board (IRB) Final 01/01/1998
Cooperative Research Institutional Review Board (IRB) Final 01/01/1998
Non-Local IRB Review Institutional Review Board (IRB) Final 01/01/1998
Sponsor-Investigator-IRB Interrelationship Good Clinical Practice (GCP), Institutional Review Board (IRB), Investigator, Sponsor Final 01/01/1998
Charging for Investigational Products Good Clinical Practice (GCP), Investigation, Investigational New Drug (IND), Medical Device Final 01/01/1998
Recruiting Study Subjects Human Subject Protection (HSP), Informed Consent, Institutional Review Board (IRB), Recruit, Recruitment Final 01/01/1998
Screening Tests Prior to Study Enrollment Human Subject Protection (HSP), Informed Consent Final 01/01/1998
Informed Consent, A Guide to Human Subject Protection (HSP), Informed Consent, Recruit, Recruitment Final 01/01/1998
Use of Investigational Products When Subjects Enter a Second Institution Human Subject Protection (HSP), Informed Consent, Investigation, Investigational Device Exemption (IDE), Investigational New Drug (IND), Institutional Review Board (IRB), Medical Device Final 01/01/1998
Off-Label and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices Investigation, Investigational New Drug (IND), Medical Device, Practice of Medicine Final 01/01/1998
Emergency Use of an Investigational Drug or Biologic Emergency, Human Subject Protection (HSP), Informed Consent, Investigational New Drug (IND), Institutional Review Board (IRB) Final 01/01/1998
Treatment Use of Investigational Drugs Human Subject Protection (HSP), Investigation, Investigational New Drug (IND), Institutional Review Board (IRB) Final 01/01/1998
Drug Study Designs Design, Good Clinical Practice (GCP), Investigation, Investigational New Drug (IND), Sponsor Final 01/01/1998
Clinical Investigator Regulatory Sanctions — Information Sheet Good Clinical Practice (GCP), Investigator, Sanction Final 01/01/1998
ICH E8: General Considerations for Clinical Trials Ethics Committee (EC), Good Clinical Practice (GCP), Human Subject Protection (HSP), Institutional Review Board (IRB), International Conference on Harmonization (ICH), Records, Sponsor Final 12/17/1997
Design Control Guidance For Medical Device Manufacturers Design, Good Manufacturing Practice (GMP), Medical Device, Sponsor Final 03/11/1997
ICH E3: Structure and Content of Clinical Study Reports Good Clinical Practice (GCP), International Conference on Harmonization (ICH), Sponsor Final 07/01/1996
ICH E7: Studies in Support of Special Populations: Geriatrics Ethics Committee (EC), Design, Diversity, Ethnicity, Gender, Human Subject Protection (HSP), International Conference on Harmonization (ICH), Sponsor Final 08/01/1994
Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs Demographic, Gender, Good Clinical Practice (GCP), Human Subject Protection (HSP), Investigation, Investigational New Drug (IND) Final 07/22/1993

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