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)
U.S. Food & Drug Administration (FDA) Guidance Documents
The International Organization for Standardization (ISO)
The U.S. Department of Health & Human Services (HHS)
Explore These Resources on the OHRP Website >
World Medical Association (WMA)
Read Declaration of Helsinki >
ACRP 2025 “Let’s Talk Guidance” Session Blog
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.
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.