Guidelines and Regulations Resource Center

ACRP is committed to being your trusted source for the most accurate and up-to-date information related to clinical research guidelines and regulations.

ACRP RESOURCES

Preparation Documents

• Updated ICH E6 Principles Guide – This overview highlights the 11 Principles​ and the changes in R3.
• ICH E6(R2) to ICH E6(R3) Comparison Document – This reference document identifies updates by Focus Area, including new terminology and definitions, added and redesigned sections, and other major changes.
• ICH Gap Analysis Template – Created by Leslie Sam for the ACRP community.
• Industry Guidance Spreadsheet – A curated list of common FDA Guidance Documents with hyperlinks.

Due to overwhelming popularity of the February 13 webinar, Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3), we have made the recording open access. If you registered for the live webinar and would like a Certificate of Attendance or purchased Contact Hours, please go to the My Live Events to complete the evaluation. The questions that were addressed during the webinar can be viewed in the ACRP Community (ACRP members-only). You can also download this graphic to demonstrate your participation on LinkedIn.

Webinars and Trainings

• Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3) – If you did not attend the live webinar and would like to purchase ACRP Contact Hours.
• The Impact of ICH E6(R3) on ACRP Certification – ACRP statement
• ICH E6(R3) Instructor Led Training Program – Contact ACRP for more details!
• Good Clinical Practice ICH E6(R3) Introduction Course – Launching in Spring 2025
• Good Clinical Practice (GCP) Simulation – Interactive training program
• Investigator Responsibilities – On-demand training program
• Facilitating Understanding in Informed Consent – Webinar replay

Blogs

• The Impact of ICH E6(R3) on GCP: Implementing New Expectations in a Culture of Quality
• Embracing the Future: Reflections on the Release of ICH E6(R3)
• Implications of Forthcoming ICH GCP E6(R3) Updates Expected Throughout Organizations: Time to Prepare

A list of Authorities and Organizations with the most relevant resources are noted below to support the awareness and education of all professionals whose roles involve conducting and leading clinical research.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

NEW! The ICH Guideline for Good Clinical Practice E6(R3) Final Version (Adopted on January 6, 2025, and released on January 14, 2025)

• ICH E6(R3) Introductory Training Presentation: Step 4 (January 24, 2024)

The following ICH guidelines are commonly referenced in ACRP educational resources and ACRP Certification Exams.

• ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• ICH E6 – Good Clinical Practice
• ICH E8 – General Considerations for Clinical Trials
• ICH E9 – Statistical Principles for Clinical Trials
• ICH E11 – Clinical Trials in Pediatric Population

Explore ICH Guidelines >

U.S. Food & Drug Administration (FDA) Guidance Documents

The FDA website lists all official FDA Guidance Documents and Code of Federal Regulations (CFR). The hyperlinks below provide direct access to the some of the most relevant U.S. FDA resources.

• Clinical Trials Guidance Documents
• The Center for Drug Evaluation and Research (CDER)
• General and Cross-Cutting Topics
• Guidance Snapshots at a Glance

The International Organization for Standardization (ISO)

The ISO is a worldwide federation of national standards bodies. This document addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

• Clinical Investigation of Medical Devices for Human Subjects

The U.S. Department of Health & Human Services (HHS)

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

• OHRP’s Compliance Oversight
• Common Rule
• Key Information and Facilitating Understanding in Informed Consent
• Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions
• Research Involving Children as Subjects and not otherwise approval by an Institutional Review Board
• Use of Single Institutional Review Board for Cooperative Research

Explore These Resources on the OHRP Website >

World Medical Association (WMA)

The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

Read Declaration of Helsinki >

ACRP ICH E6(R3) Working Group

This volunteer group of subject matter experts are committed to preparing for—and revising ACRP training courses to reflect—the updated guidance according to the ICH E6(R3) Good Clinical Practice Guideline. They will prepare webinars, blogs, articles, and handouts to clarify the changes. ACRP will communicate its plans and the impact of these anticipated changes on our training and education coursework on this page so please check back often.

ACRP 2025

As part of ACRP’s commitment to preparing for the ICH E6(R3) GCP Guidelines changes, we have assembled 17 sessions related to guidance and regulations across the agenda at ACRP 2025, Thursday, April 24 – Sunday, April 27, New Orleans. View Guidelines and Regulations Sessions>

Signature Series: Principles to Practice: An Understanding of the ICH E6(R3) Update’s Effect on Good Clinical Practice

 

RESOURCE SPOTLIGHT

This 12-page ICH R2/R3 reference document, which identifies the updates by Focus Area, including new terminology and definitions, added and redesigned sections, and other major updates. It will save you tremendous time and help take the guess work out of tracking all the guidance changes. Download >

 

ACRP DISCUSSION FORUM

Have a question about the guideline changes? Want to see what ACRP members are reporting? Login to the Discussion Forum > Not an ACRP member? Join Today!