The Association of Clinical Research Professionals

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 Coming Soon!

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.