Event Calendar

Summary of Certification
Activities

11,500 CCRPs (as of 12/31/2017)

Year 2017
  • 104 exam sites hosted
  • 2,175 candidates took CCRP exam
  • 70% passed CCRP exam
  • 2,491 CCRPs recertified
Year 2016
  • 91 exam sites hosted
  • 2,141 candidates took CCRP exam
  • 71% passed CCRP exam
  • 2,421CCRPs recertified
Year 2015
  • 91 exam sites hosted
  • 2,289 candidates took CCRP exam
  • 69% passed CCRP exam
  • 2,067CCRPs recertified
Year 2014
  • 95 exam sites hosted
  • 2,202 candidates took CCRP exam
  • 74.1% passed CCRP exam
  • 2,378 CCRPs recertified

Program Overview

Purpose

SOCRA established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so recognized may use the "Certified Clinical Research Professional" or "CCRP® (SOCRA)" designation.

Scope

The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials.

SOCRA developed the Certified Clinical Research Professional Certification program to evaluate a CRP’s knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice (E6) (ICH/GCP), ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A), the United States Code of Federal Regulations (CFR) and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki.

This certification is not intended for those professionals working exclusively under Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) regulations.

Standards of Practice

It is the goal of the Society of Clinical Research Associates to encourage members, and assure the competency of certified members, in their knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the ICH Guidelines, the U.S. Code of Federal Regulations, and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report, and the Declaration of Helsinki. Members are expected to adhere to national, state, local and provincial regulations and to international guidelines published by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable Federal, state and local laws and policies.

Standards of Practice include an understanding of and application of basic concepts of Good Clinical (Research) Practice, including:

  • The Nuremberg Code
  • The Belmont Report
  • The Declaration of Helsinki
  • 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
  • 45 U.S. Code of Federal Regulations - Part 46
  • ICH Harmonised Guideline for Good Clinical Practice E6(R2), and
  • ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)