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Standards of Practice

The goal of the Canadian Association of Clinical Research Specialists is 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 GCP Guidelines, the 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 Harmonization 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 Practice (GCP), 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 Harmonized Guideline for Good Clinical Practice E6(R2), and
  • ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)

Resources: Or Exam References

https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1) Guidance for Industry (March 2018 Procedural)

https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf

ICH HARMONISED TRIPARTITE GUIDELINE CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A

FDA regulations governing the conduct of clinical trials describe good clinical practices (GCPs) for studies with both human and non-human animal subjects