Clinical Trials Guidance Documents
Guidance documents listed below represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject protection.
Guidance documents are not binding for FDA or the public. Guidance should be viewed as recommendations unless specific regulatory or statutory requirements are cited. An alternative approach may be used if the approach satisfies the requirements of the applicable statute and regulations.
Some links embedded within guidance documents may have changed since the document was published. If a link does not work, please search for the document by title or contact FDA for assistance.
Withdrawn or Expired Clinical Trial Guidance Documents
| Guidance Title | Topic | Draft or Final | Date Issued |
|---|---|---|---|
| Processes and Practices Applicable to Bioresearch Monitoring Inspections | Clinical Trials, Administrative / Procedural | Draft | 6/05/2024 |
| Cancer Clinical Trial Eligibility Criteria: Performance Status | Clinical Trials, Clinical - Medical | Draft | 4/25/2024 |
| Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications | Clinical Trials, Clinical - Medical | Draft | 4/25/2024 |
| Cancer Clinical Trial Eligibility Criteria: Laboratory Values | Clinical Trials, Clinical - Medical | Draft | 4/25/2024 |
| Informed Consent | Good Clinical Practice (GCP) | Final | 8/15/2023 |
| Decentralized Clinical Trials for Drugs, Biological Products, and Devices | Clinical - Medical | Draft | 5/3/2023 |
| Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers | Administrative / Procedural | Draft | 3/15/2023 |
| Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products | Real World Data/Real World Evidence (RWD/RWE) | Draft | 01/31/2023 |
| Clinical Investigator Administrative Actions — Disqualification | Disqualification, Good Clinical Practice (GCP), Human Subject Protection (HSP), Investigator, Inspection | Final | 12/01/2022 |
| Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment | Clinical - Medical | Final | 10/17/2022 |
| Tissue Agnostic Drug Development in Oncology | Clinical - Medical | Draft | 10/17/2022 |
| Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials | Clinical - Medical | Draft | 10/17/2022 |
| Ethical Considerations for Clinical Investigations of Medical Products Involving Children | Clinical - Medical | Draft | 09/23/2022 |
| Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products | Real World Data/Real World Evidence (RWD/RWE) Administrative/Procedural | Final | 09/08/2022 |
| Digital Health Technologies for Remote Data Acquisition in Clinical Investigations | Clinical - Medical | Draft | 12/22/2021 |
| Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices | Device & Drug Safety | Draft | 09/29/2021 |
| Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry | Drug Safety | Draft | 06/25/2021 |
| Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) | Good Clinical Practice (GCP), Human Subject Protection (HSP), Investigator, 1572 | Draft | 05/19/2021 |
| 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, Sex, 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 |
| Postmarketing Studies and Clinical Trials - Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act | Bioavailability, design, drug safety, good clinical practice, investigation, postmarketing | Draft | 10/25/2019 |
| 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 | Sex, 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, Sex, Investigation, Medical Device, Pediatric | Final | 09/12/2017 |
| 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, Sex, 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 |
| 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, Sex, 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 |
| 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, Sex, 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, Sex, International Conference on Harmonization (ICH), Sponsor | Final | 06/10/1998 |
| Evaluation of Sex Differences in Clinical Investigations | Demographic, Sex, 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 |
| 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 |
| 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 |
| 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, Sex, Human Subject Protection (HSP), International Conference on Harmonization (ICH), Sponsor | Final | 08/01/1994 |
| Study and Evaluation of Sex Differences in the Clinical Evaluation of Drugs | Demographic, Sex, Good Clinical Practice (GCP), Human Subject Protection (HSP), Investigation, Investigational New Drug (IND) | Final | 07/22/1993 |
Resources For You
- Clinical Trials and Human Subject Protection
- Electronic Code of Federal Regulations (eCFR)
- Search for FDA Guidance
- Websites with Information about Clinical Trials