Clinical Trials Guidance Documents | FDA
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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Draft Guidance Documents
Draft guidance documents have been proposed and are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.
Draft Guidance Documents: Good Clinical Practice
(/regulatory-information/search-fda-guidancedocuments/draft-guidance-documents-goodclinical-practice)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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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 (/contact-fda-1).
General Information Sheet Guidance
Charging for Investigational Products - Information
Sheet (/regulatory-information/search-fdaguidance-documents/charging-investigationalproducts) -01/1998
Cooperative Research - Information Sheet
(/regulatory-information/search-fda-guidancedocuments/cooperative-research) -01/1998
Informed Consent, A Guide to - Information Sheet
(/regulatory-information/search-fda-guidancedocuments/guide-informed-consent) - 01/1998
Institutional Review Boards Frequently Asked
Questions - Information Sheet (/regulatoryinformation/search-fda-guidancedocuments/institutional-review-boards-frequentlyasked-questions) - 01/1998
Non-local IRB Review - Information Sheet
(/regulatory-information/search-fda-guidancedocuments/non-local-irb-review) 01/1998
"Off-Label" and Investigational Use Of Marketed
Drugs, Biologics, and Medical Devices - Information
Sheet (/regulatory-information/search-fdaguidance-documents/label-and-investigational-usemarketed-drugs-biologics-and-medical-devices) 01/1998
Payment and Reimbursement to Research Subjects Information Sheet (/regulatory-information/searchfda-guidance-documents/payment-andhttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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reimbursement-research-subjects) - 01/2018
Recruiting Study Subjects - Information Sheet
(/regulatory-information/search-fda-guidancedocuments/recruiting-study-subjects) - 01/1998
Screening Tests Prior to Study Enrollment Information Sheet (/regulatory-information/searchfda-guidance-documents/screening-tests-priorstudy-enrollment) - 01/1998
Sponsor - Investigator - IRB Interrelationship Information Sheet (/regulatory-information/searchfda-guidance-documents/sponsor-investigator-irbinterrelationship) - 01/1998
Use of Investigational Products When Subjects Enter
a Second Institution - Information Sheet
(/regulatory-information/search-fda-guidancedocuments/use-investigational-products-whensubjects-enter-second-institution) - 01/1998
Drugs and Biologics Information
Sheet Guidance
Drug Study Designs - Information Sheet
(/regulatory-information/search-fda-guidancedocuments/drug-study-designs) - 01/1998
Emergency Use of an Investigational Drug or
Biologic - Information Sheet (/regulatoryinformation/search-fda-guidancedocuments/emergency-use-investigational-drug-orbiologic) - 01/1998
Evaluation of Gender Differences in Clinical
Investigations - Information Sheet (/regulatoryinformation/search-fda-guidancedocuments/evaluation-gender-differences-clinicalinvestigations) - 01/1998
Statement of Investigator (Form FDA 1572) Frequently Asked Questions - Information Sheet
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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(/regulatory-information/search-fda-guidancedocuments/frequently-asked-questions-statementinvestigator-form-fda-1572) - 05/2010
Treatment Use of Investigational Drugs Information Sheet (/regulatory-information/searchfda-guidance-documents/treatment-useinvestigational-drugs) - 01/1998
Waiver of IRB Requirements for Drug and Biological
Product Studies - Information Sheet (/regulatoryinformation/search-fda-guidancedocuments/waiver-irb-requirements-drug-andbiological-product-studies) -10/2017
Medical Devices Information Sheet
Guidance
Medical Devices, Frequently Asked Questions About
- Information Sheet (/regulatoryinformation/search-fda-guidancedocuments/frequently-asked-questions-aboutmedical-devices) - 01/2006
Significant Risk and Nonsignificant Risk Medical
Device Studies - Information Sheet (/regulatoryinformation/search-fda-guidancedocuments/significant-risk-and-nonsignificant-riskmedical-device-studies) - 01/2006
FDA Operations Information Sheet
Guidance
Clinical Investigator Administrative Actions Disqualification (/regulatory-information/searchfda-guidance-documents/clinical-investigatoradministrative-actions-disqualification) - 03/2014
FDA Inspections of Clinical Investigators Information Sheet (/regulatory-information/searchfda-guidance-documents/fda-inspections-clinicalhttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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investigators) - 06/2010
FDA Institutional Review Board Inspections Information Sheet (/regulatory-information/searchfda-guidance-documents/fda-institutional-reviewboard-inspections) - 10/2006
General Guidance Documents
21 CFR 50.54 - Additional Safeguards for Children in
Clinical Investigations, Process for Handling
Referrals to FDA Under (/regulatoryinformation/search-fda-guidancedocuments/process-handling-referrals-fda-under21-cfr-5054-additional-safeguards-childrenclinical) - 12/2006
Clinical Holds, Submitting and Reviewing Complete
Responses to (/regulatory-information/search-fdaguidance-documents/submitting-and-reviewingcomplete-responses-clinical-holds-revised)10/2000
Clinical Lactation Studies - Study Design, Data
Analysis, and Recommendations for Labeling
(/about-fda/page-not-found) -02/2005
Data Monitoring Committees for Clinical Trial
Sponsors, The Establishment and Operation of
Clinical Trial (/regulatory-information/search-fdaguidance-documents/establishment-and-operationclinical-trial-data-monitoring-committees) 03/2006
Data Retention When Subjects Withdraw from FDARegulated Clinical Trials (/regulatoryinformation/search-fda-guidance-documents/dataretention-when-subjects-withdraw-fda-regulatedclinical-trials) - 10/2008
Exception from Informed Consent Requirements for
Emergency Research (/regulatoryhttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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information/search-fda-guidancedocuments/exception-informed-consentrequirements-emergency-research) - 04/2013
Financial Disclosure by Clinical Investigators
(/regulatory-information/search-fda-guidancedocuments/financial-disclosure-clinicalinvestigators) - 02/2013
Financial Relationships and Interests in Research
Involving Human Subjects
(https://www.hhs.gov/ohrp/regulations-andpolicy/guidance/financial-conflict-ofinterest/index.html) -05/2004
Impact of Certain Provisions of the Revised Common
Rule on FDA-Regulated Clinical Investigations
(/regulatory-information/search-fda-guidancedocuments/impact-certain-provisions-revisedcommon-rule-fda-regulated-clinical-investigations) 10/2018
Independent Consultants for Biotechnology Clinical
Trial Protocols (/regulatory-information/search-fdaguidance-documents/independent-consultantsbiotechnology-clinical-trial-protocols) - 08/2004
Investigator Responsibilities - Protecting the Rights,
Safety, and Welfare of Study Subjects (/regulatoryinformation/search-fda-guidancedocuments/investigator-responsibilities-protectingrights-safety-and-welfare-study-subjects) - 10/2009
Oversight of Clinical Investigations - A Risk-Based
Approach to Monitoring (/regulatoryinformation/search-fda-guidancedocuments/oversight-clinical-investigations-riskbased-approach-monitoring) - 08/2013
Patient-Reported Outcome Measures: Use in
Medical Product Development to Support Labeling
Claims (final) (/regulatory-information/search-fda-
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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guidance-documents/patient-reported-outcomemeasures-use-medical-product-developmentsupport-labeling-claims) - 12/2009
Pharmacogenomic Data Submissions (/regulatoryinformation/search-fda-guidancedocuments/pharmacogenomic-datasubmissions) 03/2005
Race and Ethnicity Data in Clinical Trials, Collection
of (/regulatory-information/search-fda-guidancedocuments/collection-race-and-ethnicity-dataclinical-trials) - 10/2016
Institutional Review Boards (IRBs)
and Informed Consent Guidance
Documents
Adverse Event Reporting to IRBs - Improving
Human Subject Protection (/regulatoryinformation/search-fda-guidancedocuments/adverse-event-reporting-irbs-improvinghuman-subject-protection) - 01/2009
Centralized IRB Review Process in Multicenter
Clinical Trials, Using a (/regulatoryinformation/search-fda-guidance-documents/usingcentralized-irb-review-process-multicenter-clinicaltrials) - 03/2006
Considerations When Transferring Clinical
Investigation Oversight to Another IRB (/regulatoryinformation/search-fda-guidancedocuments/considerations-when-transferringclinical-investigation-oversight-another-irb) 05/2014
HIPAA Authorizations Under FDA Regulations, IRB
Review of Stand-Alone (/regulatoryinformation/search-fda-guidance-documents/irbreview-stand-alone-hipaa-authorizations-under-fdahttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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regulations) - 10/2003
Informed Consent Elements, 21 CFR 50.25(c),
Questions and Answers (/regulatoryinformation/search-fda-guidancedocuments/questions-and-answers-informedconsent-elements-21-cfr-ss-5025c) - 02/2012
Institutional Review Board (IRB) Written
Procedures (/regulatory-information/search-fdaguidance-documents/institutional-review-board-irbwritten-procedures) - 05/2018
I (/media/83121/download)RB Continuing Review
After Clinical Investigation Approval (/regulatoryinformation/search-fda-guidance-documents/irbcontinuing-review-after-clinical-investigationapproval) - 02/2012
IRB Registration, Frequently Asked Questions
(/regulatory-information/search-fda-guidancedocuments/frequently-asked-questions-irbregistration) - 07/2009
IRB Responsibilities for Reviewing the Qualifications
of Investigators, Adequacy of Research Sites, and the
Determination of Whether an IND/IDE is Needed
(/regulatory-information/search-fda-guidancedocuments/irb-responsibilities-reviewingqualifications-investigators-adequacy-research-sitesand) - 08/2013
I (/regulatory-information/search-fda-guidancedocuments/irb-waiver-or-alteration-informedconsent-clinical-investigations-involving-no-moreminimal-risk)RB Waiver or Alteration of Informed
Consent for Clinical Investigations Involving No
More Than Minimal Risk to Human Subjects
(/regulatory-information/search-fda-guidancedocuments/irb-waiver-or-alteration-informedconsent-clinical-investigations-involving-no-moreminimal-risk) - 07/2017
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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Minutes of Institutional Review Board (IRB)
Meetings - Guidance for Institutions and IRBs
(/regulatory-information/search-fda-guidancedocuments/minutes-institutional-review-board-irbmeetings) - 09/2017
Drugs and Biologics Guidance
Documents
Bioavailability and Bioequivalence Testing Samples,
Handling and Retention of (/regulatoryinformation/search-fda-guidancedocuments/handling-and-retention-bioavailabilityba-and-bioequivalence-be-testing-samples) 08/2004
Charging for Investigational Drugs Under an IND —
Qs & As (/regulatory-information/search-fdaguidance-documents/charging-investigationaldrugs-under-ind-questions-and-answers) -06/2016
Clinical Holds Following Clinical Investigator
Misconduct, The Use of (/regulatoryinformation/search-fda-guidance-documents/useclinical-holds-following-clinical-investigatormisconduct) - 09/2004
Clinical Studies Section of Labeling for Human
Prescription Drug and Biological Products - Content
and Format (/regulatory-information/search-fdaguidance-documents/clinical-studies-sectionlabeling-human-prescription-drug-and-biologicalproducts-content-and-format) - 01/2006
Enrichment Strategies for Clinical Trials to Support
Approval of Human Drugs and Biological Products
(/regulatory-information/search-fda-guidancedocuments/enrichment-strategies-clinical-trialssupport-approval-human-drugs-and-biologicalproducts) -03/2019
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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Expanded Access to Investigational Drugs for
Treatment Use — Qs & As (/regulatoryinformation/search-fda-guidancedocuments/expanded-access-investigational-drugstreatment-use-questions-and-answers) -10/2017
Exploratory IND Studies (/regulatoryinformation/search-fda-guidancedocuments/exploratory-ind-studies) - 01/2006
FDA Acceptance of Foreign Clinical Studies Not
Conducted Under an IND: Frequently Asked
Questions (/regulatory-information/search-fdaguidance-documents/fda-acceptance-foreignclinical-studies-not-conducted-under-indfrequently-asked-questions) - 03/2012
Food-Effect Bioavailability and Fed Bioequivalence
Studies (/regulatory-information/search-fdaguidance-documents/food-effect-bioavailabilityand-fed-bioequivalence-studies) - 12/2002
Gender Differences in the Clinical Evaluation of
Drugs, Guideline for the Study and Evaluation of
(/regulatory-information/search-fda-guidancedocuments/study-and-evaluation-genderdifferences-clinical-evaluation-drugs) - 07/1993
Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment (/regulatoryinformation/search-fda-guidance-documents/goodpharmacovigilance-practices-andpharmacoepidemiologic-assessment) - 03/2005
IND Exemptions for Studies of Lawfully Marketed
Drug or Biological Products for the Treatment of
Cancer (/regulatory-information/search-fdaguidance-documents/ind-exemptions-studieslawfully-marketed-drug-or-biological-productstreatment-cancer) - 01/2004
Investigational New Drug Applications (INDs) -
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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Determining Whether Human Research Studies Can
Be Conducted Without an IND (/regulatoryinformation/search-fda-guidancedocuments/investigational-new-drug-applicationsinds-determining-whether-human-research-studiescan-be) - 09/2013
Premarketing Risk Assessment (/regulatoryinformation/search-fda-guidancedocuments/premarketing-risk-assessment) 03/2005
Providing Regulatory Submissions in Electronic
Format - Certain Human Pharmaceutical Product
Applications and Related Submissions Using the
eCTD Specifications (/about-fda/page-not-found) 01/2019
Risk Minimization Action Plans, Development and
Use of (/regulatory-information/search-fdaguidance-documents/development-and-use-riskminimization-action-plans) - 03/2005
Safety Reporting Requirements for INDs
(Investigational New Drug Applications) and BA/BE
(Bioavailability/Bioequivalence) Studies
(/regulatory-information/search-fda-guidancedocuments/safety-reporting-requirements-indsinvestigational-new-drug-applications-and-babe) 12/2012
Safety Reporting Requirements for INDs and BA/BE
Studies- Small Entity Compliance Guide
(/regulatory-information/search-fda-guidancedocuments/safety-reporting-requirements-inds-andbabe-studies) - 12/2012
Medical Devices Guidance Documents
Acceptance of Clinical Data to Support Medical
Device Applications and Submissions: Frequently
Asked Questions (/regulatory-information/searchhttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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fda-guidance-documents/acceptance-clinical-datasupport-medical-device-applications-andsubmissions-frequently-asked) - 02/2018
Analyte Specific Reagents (ASRs), Commercially
Distributed: Frequently Asked Questions
(/regulatory-information/search-fda-guidancedocuments/commercially-distributed-analytespecific-reagents-asrs-frequently-asked-questions) 09/2007
Distribution of In Vitro Diagnostic Products Labeled
for Research Use Only or Investigational Use Only
(/regulatory-information/search-fda-guidancedocuments/distribution-vitro-diagnostic-productslabeled-research-use-only-or-investigational-useonly) -11/2013
Evaluation and Reporting of Age-, Race-, and
Ethnicity-Specific Data in Medical Device Clinical
Studies (/regulatory-information/search-fdaguidance-documents/evaluation-and-reporting-agerace-and-ethnicity-specific-data-medical-deviceclinical-studies) - 09/2017
Factors to Consider When Making Benefit-Risk
Determinations in Medical Device Premarket
Approval and De Novo Classifications (/regulatoryinformation/search-fda-guidancedocuments/factors-consider-when-making-benefitrisk-determinations-medical-device-premarketapproval-and-de) - 08/2016
Humanitarian Device Exemption (HDE) Program
(/regulatory-information/search-fda-guidancedocuments/humanitarian-device-exemption-hdeprogram) - 08/2019
Humanitarian Use Device (HUD) Designations
(/regulatory-information/search-fda-guidancedocuments/humanitarian-use-device-huddesignations) - 01/2013
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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Guidance on Informed Consent for In Vitro
Diagnostic Device Studies Using Leftover Human
Specimens that are Not Individually Identifiable
(/regulatory-information/search-fda-guidancedocuments/guidance-informed-consent-vitrodiagnostic-device-studies-using-leftover-humanspecimens-are-not) - 04/2006
In Vitro Diagnostic (IVD) Device Studies Frequently Asked Questions (/regulatoryinformation/search-fda-guidance-documents/vitrodiagnostic-ivd-device-studies-frequently-askedquestions) - 06/2010
General Principles of Software Validation
(/regulatory-information/search-fda-guidancedocuments/general-principles-software-validation) 01/2002
Electronic Data Guidance Documents
Computerized Systems Used in Clinical
Investigations (/regulatory-information/search-fdaguidance-documents/computerized-systems-usedclinical-investigations) - 05/2007
Electronic Informed Consent in Clinical
Investigations, use of - Questions and Answers
(/regulatory-information/search-fda-guidancedocuments/use-electronic-informed-consentclinical-investigations-questions-and-answers) 12/2016
Electronic Source Data in Clinical Investigations
(/regulatory-information/search-fda-guidancedocuments/electronic-source-data-clinicalinvestigations) - 09/2013
Part 11, Electronic Records; Electronic Signatures Scope and Application (/regulatoryinformation/search-fda-guidance-documents/part11-electronic-records-electronic-signatures-scopehttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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and-application) - 08/2003
Manufacturing Requirements for
Investigational Products Guidance
Documents
Current Good Manufacturing Practice for Phase 1
Investigational Drugs (/regulatoryinformation/search-fda-guidancedocuments/current-good-manufacturing-practicephase-1-investigational-drugs) - 07/2008
Design Control Guidance For Medical Device
Manufacturers (/regulatory-information/search-fdaguidance-documents/design-control-guidancemedical-device-manufacturers) - 03/1997
INDs for Phase 2 and Phase 3 Studies Chemistry,
Manufacturing, and Controls Information
(/regulatory-information/search-fda-guidancedocuments/inds-phase-2-and-phase-3-studieschemistry-manufacturing-and-controlsinformation) - 05/2003
Resources For You
Clinical Trials and Human Subject Protection
(/science-research/science-and-research-specialtopics/clinical-trials-and-human-subject-protection)
About GCP Guidance Documents (Including
Information Sheets) and Notices (/guidancedocuments-including-information-sheets-andnotices)
Information Sheet Guidance for Institutional Review
Boards (IRBs), Clinical Investigators, and Sponsors
(/science-research/guidance-documents-includinginformation-sheets-and-notices/information-sheetguidance-institutional-review-boards-irbs-clinicalinvestigators-and-sponsors)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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Selected FDA GCP/Clinical Trial Guidance
Documents (/science-research/guidancedocuments-including-information-sheets-andnotices/selected-fda-gcpclinical-trial-guidancedocuments)
ICH Guidance Documents Related to Good Clinical
Practice (/science-research/guidance-documentsincluding-information-sheets-and-notices/ichguidance-documents)
Proposed GCP Regulations and Draft Guidances
(/proposed-regulations-and-draft-guidances)
GCP/Clnical Trial Notices (/scienceresearch/guidance-documents-includinginformation-sheets-and-notices/gcpclinical-trialnotices)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
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