The Association of Clinical Research Professionals

ACRP Learning Update

ACRP is happy to announce forthcoming updates to several courses in the ACRP catalog.

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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.

A list of Authorities and Organizations with the most relevant resources are noted below. This Resource Center is designed 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)

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.

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.

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 Resources

  • Implications of Forthcoming ICH GCP E6(R3) Updates Expected Throughout Organizations: Time to Prepare (Blog) Read >
  • Good Clinical Practice (GCP) Simulation (Interactive training program) Enrollment Options >
  • Industry Guidance Spreadsheet (A curated list of common FDA Guidance Documents with hyperlinks) Download >
  • Investigator Responsibilities (On-demand training program) Enrollment Options >
  • Facilitating Understanding in Informed Consent (Webinar replay) Enrollment Options >

The ACRP ICH E6(R3) Working Group is a volunteer group of subject matter experts who 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. 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.

 

As part of ACRP’s commitment to preparing for the ICH E6(R3) Good Clinical Practice 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.

Explore the ‘Let’s Talk Guidance’ curated sessions >

WELCOME TO THE RESOURCE CENTER

Bridget Gonzales, Head of ACRP Educational Programs, provides a brief overview of the resource center and shares what to expect from ACRP as we prepare for the coming changes in the ICH E6(R3) Good Clinical Practice Guidelines.

ACRP ICH E6(R3) Working Group members will prepare webinars, blogs, articles, and handouts to clarify the changes. More details and the links to enroll will be posted here when available.

 

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!

Resource Center FAQs

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 bottom 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 Certification exams will align with the current ICH Guidelines as listed on the ICH website as of October 1, 2024. Any updates to the guidelines made after this date will be incorporated into the exams within one year.

ICH E6(R3) FAQs

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

The International Council for Harmonisation (ICH) is expected to release its long-awaited and final guidance to update ICH E6(R2), following 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 courseware 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 the first half of 2025.