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 Training Courses
ACRP has updated 17 training courses to align with the latest ICH E6(R3) guidelines—designed to support confident application in your daily work. While available to the broader clinical research community, these courses are offered to ACRP Members at no cost or at reduced rates.
-
Good Clinical Practice (GCP) ICH E6(R3) – Microlearning modules, interactive real-world scenarios, and relevant knowledge checks demonstrate how various aspects of a clinical trial are governed under today’s ICH GCP E6(R3) standards and who is responsible for ensuring compliance. $0/Members (No Contact Hours); $60/Members (4.0 Contact Hours); $239/Nonmembers (4.0 Contact Hours)
-
Essential Records: An Introduction Based on ICH E6(R3) - This course introduces ICH E6(R3) principles and helps build confidence in managing Essential Records using ALCOA‑C+–aligned record management practices. Explore how well‑managed records support data integrity, effective Trial Master File (TMF) practices, inspection readiness, and risk‑based quality management throughout the trial lifecycle. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
Form FDA 1572 Essentials: Updated for ICH E6(R3) – This practical training equips sponsor personnel and site staff with the knowledge and tools to complete the Statement of Investigator accurately and confidently—right from the start. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
Informed Consent Scenarios with ICH E6(R3) Guidance – Participants will actively engage with complex, real-world situations, strengthening their ability to apply regulatory requirements and ethical standards into practice. $0/Members (No Contact Hours); $30/Members (2.0 Contact Hours); $239/Nonmembers (2.0 Contact Hours)
-
Ethics and Human Subject Protection: An Introduction with ICH E6(R3) Guidance – Gain an understanding of the principles that guide ethical decision-making and learn how to apply them to protect human subjects and maintain the integrity of your work. $0/Members (No Contact Hours); $75/Members (5.0 Contact Hours); $375/Nonmembers (5.0 Contact Hours)
-
Ethical Foundations in Clinical Trials: A Refresher Course with ICH E6(R3) Guidance – Building on core ethical principles, this refresher course shifts the focus from theory to practice—exploring how ethical conduct plays out in real-world scenarios. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
eResearch in Practice: Managing Clinical Trials with ICH E6(R3) Guidance – This training explores how clinical researchers can manage electronic systems, remote data capture, and decentralized models while staying compliant with U.S. and EU regulations. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
Clinical Trials 101: An Introduction with ICH E6(R3) Guidance – Understand the essentials of clinical trials and the global standards that govern them. This course provides a clear, structured introduction to the process, roles, and guidelines that ensure ethical and effective research. FREE for ACRP Members and Nonmembers (0 Contact Hours)
-
Understanding Clinical Trial Protocols Under ICH E6(R3) Guidelines – Learn how to incorporate Quality by Design (QbD), risk-based thinking, and feasibility assessment into protocol planning, ensuring compliance and transparency throughout the trial lifecycle. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
Enhancing Clinical Trial Recruitment, Accrual, and Retention with ICH E6(R3) Guidance – Gain practical strategies to evaluate recruitment pathways, identify barriers to participation, and implement thoughtful improvements grounded in ICH E6(R3) principles. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
Metrics‑Driven Recruitment & Retention Strategies with ICH E6(R3) Guidance - Explore how metrics can support quality planning, participant-centered outreach, and continuous improvement throughout the trial lifecycle in alignment with ICH E6(R3) expectations. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
Decentralized Clinical Trials (DCTs): An Introduction with ICH E6(R3) Guidance – This self‑paced course introduces core concepts, common decentralized and hybrid trial approaches, advantages and challenges of implementation, and key operational, regulatory, and ethical considerations that influence feasibility and success. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
QMS Essentials for Sites and Sponsors Under ICH E6(R3) Guidelines - Explore how to build and maintain a Quality Management System that protects participant safety, ensures data integrity, supports effective sponsor and site oversight, and promotes ongoing regulatory compliance. $0/Members (No Contact Hours); $22.50/Members (1.5 Contact Hours); $149/Nonmembers (1.5 Contact Hours)
-
Mastering the Event Reporting Cycle: Adverse Events (AEs) with ICH E6(R3) Guidance – This course provides a clear, practical walkthrough of the full adverse event reporting cycle—what must be reported, why it matters, and how responsibilities are shared across site, sponsor, and service provider teams. Updated with the latest principles from ICH E6(R3) and aligned with ICH E2A. $189/Members (1.5 Contact Hours); $239/Nonmembers (1.5 Contact Hours)
-
ICH E6(R3) Gap Analysis Tool – This self-assessment tool helps clinical research professionals identify strengths and knowledge gaps in their understanding of ICH Good Clinical Practice (GCP), with particular emphasis on the principles and concepts reflected in ICH E6(R3). $14/Members (2.0 Contact Hours); $29/Nonmembers (2.0 Contact Hours)
-
Statistical Principles for Clinical Trials Overview of ICH E9 and ICH E6(R3) - This course is designed for non-statisticians, focusing on practical understanding rather than mathematical detail. Examine key concepts such as variability and uncertainty, bias, randomization and blinding, hypothesis testing, and analysis strategies, as well as how treatment effects are defined using estimands. $189/Members (1.5 Contact Hours); $239/Nonmembers (1.5 Contact Hours)
-
The Drug Development Process Aligning ICH E8 and ICH E6(R3) – This course demonstrates how development plans, trial objectives, and quality-focused decision-making align across the clinical development lifecycle. Explore how risk-proportionate, quality-by-design approaches—and Critical-to-Quality (CtQ) thinking—support participant safety, reliable results, and operational feasibility in real-world clinical research. $189/Members (1.5 Contact Hours); $239/Nonmembers (1.5 Contact Hours)
ACRP Instructor Led Training Program
If your organization would benefit from a deeper dive into the guidance changes, ACRP is offering a customized Instructor Led Training Program (virtual or in-person). Contact us >
ICH E6(R3) Preparation Documents
- A Pragmatic Guide for Migrating Investigator Sites to ICH E6(R3)
- Updated ICH E6 Principles Guide
- ICH E6(R2) to ICH E6(R3) Comparison Document
- ICH Gap Analysis Template
- Industry Guidance Spreadsheet
Webinar and Conference Replays
- Mastering the Migration: A Practical Guide for Sites Moving to ICH E6(R3)
- ICH E6(R3): Real-World Questions & Answers
- Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)
- Facilitating Understanding in Informed Consent
- A Review of ICH E8 (R1) General Considerations for Clinical Trials
ACRP Insights
Blogs
- ICH E6(R3): Delivering Quality Outcomes Through Compliance
- Protocol Deviations: Making Sense of FDA’s New Guidance
- Adjusting to Changes in Policy at HHS in 2026 and Beyond
- Who Regulates the Regulators in an AI-Assisted World?
- What ICH E6(R3) Really Asks of Us: Beyond the Buzzwords
- Modernizing the Handling of Research Misconduct: What Institutions Need to Know
- Shining a Light on IRB Decisions: Mock IRB Meeting Reveals Processes
- The Right Tools Can Ease Second-Guessing on Secondary Uses for Researchers
- FDA Publishes ICH E6(R3): What it Means for U.S. Clinical Trials
- Clinical Research Practices, Professionals, and Participants in the Spotlight at ACRP 2025
- 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
Clinical Researcher Articles
- Measuring Quality in the Age of AI: Why Regulatory Writing Needs a True Standard
- The Need for Clinical Research Sites to Transition to e-Regulatory Binders: Strategies, Pros, and Cons
- ICH E6(R3) Unpacked: Diving Deep into the Impacts of the Guideline Changes
- What Every Clinical Researcher Should Know About Institutional Review Boards
- ICH E6(R3): Transforming the Future of Clinical Trials with Enhanced Efficiency, Safety, and Innovation—A Commentary
Announcements
RESOURCE SPOTLIGHTS
This foundational training course supports compliance with new Good Clinical Practice (GCP) guidelines governing clinical research operations and execution globally. Enroll >
This new report focuses on what sites need to do as their teams roll up their sleeves and convert their policies, checklists, quality improvement tools, and operations from ICH E6(R2) to R3. 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!
External Resources
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.
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 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).
ICH E6(R3) FAQs
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.