Guidelines and Regulations Resource Center

EXTERNAL RESOURCES

Relevant resources from Authorities and Organizations support the education of all researchers.

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

• Guideline for Good Clinical Practice E6(R3) Final Version (Adopted on January 6, and released on January 14, 2025)
• ICH E6(R3) Introductory Training Presentation: Step 4 (January 24, 2025)

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

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

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

• Final Guidance Document for Industry: E6(R3) Good Clinical Practice
• Clinical Trials Guidance Documents
• The Center for Drug Evaluation and Research (CDER)
• General and Crosscutting Topics
• Guidance Snapshots at a Glance

The International Organization for Standardization (ISO)

The ISO is a worldwide federation of national standards bodies. Clinical Investigation of Medical Devices for Human Subjects 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.

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

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.

How do I know which guidance pertains to my role?

Every role is different and can depend on the type of trials and indications you are working on. ACRP has created a list of the most common guidance referenced within our resources and utilized on our certification exams. This is not an exhaustive list but rather a list of some of the common guidance.

Do the links direct me to a particular guidance document?

There are a few links that direct you directly to the guidance (ISO and WMA), the rest will direct you to resource pages that may need to be searched for the guidance you are looking for.

Does ACRP have any additional resources to learn more about clinical research regulations and guidance?

At the top of the Guidance and Regulations Resource Center, you will find ACRP resources related to guidance within the industry. These resources may share best practices in implementing these guidelines as well as resources for learning and testing your know knowledge of the guidance.

When will the ACRP Certification Exams reflect the ICH Guideline changes?

ACRP will incorporate the updated ICH Guideline for Good Clinical Practice E6(R3) into all ACRP Certification examinations within the next two years, based on its final adoption date of January 6, 2025. This ensures that candidates have sufficient time to accumulate the required 3,000 hours of professional experience under the revised guideline. Please read additional details in this announcement (dated February 25, 2025).

What are the changes expected for ICH E6(R3)?

The International Council for Harmonisation (ICH) released its long-awaited and final guidance to update ICH E6(R2) in January 2025. The follows the first draft release which was disseminated in 2023. The new guidance is ICH E6(R3). This standard helps to assure that the rights, safety, and well-being of trial participants are protected, that the conduct is consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial results are reliable.

How will this pending change from the ICH E6 impact my role—or the roles of my team?

The changes in the ICH E6 guideline impact all those whose roles involve conducting and leading clinical research. It is critical to understand the specific guidance changes and their impact on the day-to-day implementation of clinical trials and studies—and how to incorporate the changes into trial implementation.

When should we be expected to put these changes into action?

Upon release of the new guidance, every organization—whether sponsor, CRO, or site—should immediately take action to review the new guidance and understand the changes. ACRP will release a series of resources that will help you understand and communicate the changes to your team and into your organization.

How do I train my teams on the new guidance?

ACRP is responding rapidly to adapt all its educational and training materials to ensure the new guidance is incorporated. Our first priority will be to relaunch our Introduction to Good Clinical Practice course and adapt all ACRP Foundational Training. We will also ensure all ACRP Continuing Education is updated, an effort we expect to continue through 2025.