Scope and Standards of Practice
The standards upon which this certification program is based have been set forth by SOCRA to promote recognition and continuing excellence in the ethical conduct of clinical trials. It is the goal of SOCRA 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. Members are expected to adhere to national, state, local and provincial regulations and to international guidelines published by the International Conference for 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)
- 42 CFR Part 11 (ClinicalTrials.gov)
*Content of the Certification Examination related to the update of ICH Harmonised Guideline, Guideline for Good Clinical Practice, E6(R3)
The final version of The ICH Harmonised Guideline, Guideline for Good Clinical Practice, E6(R3) was adopted on January 6, 2025. On January 27, 2025, the European Medicines Agency (EMA) announced an effective date of July 23, 2025 for E6 (R3).
The Current SOCRA Certification Examination content is based on the ICH Harmonised Guideline, Guideline for Good Clinical Practice, E6(R2). Beginning January 1, 2026 the exam content will reflect the ICH Harmonised Guideline, Guideline for Good Clinical Practice, E6(R3).