Certification Reference Manual

Certification Program Reference Manual for Clinical Research Certification Examination

  • 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
  • Sample regulatory forms from FDA
  • ICH GCP Guideline for Good Clinical Practice (E6), and
  • ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)

 

Note: Once a candidate's certification application is approved, a complimentary electronic copy of the reference manual will be sent.

Please complete the form below or click here to download a printable version of the Certification Program Reference Manual Print Request Form.

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