Both ICH GCP E6 Guideline and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
- Discuss the purpose and governing bodies of ICH and ISO
- Explore the core principles of each document
- Describe similarities and key differences in content and approach
- Identify additional sources of information relating to the compliant conduct and oversight of medical device studies
- Project Managers
- Clinical Research Associate Managers
- Clinical Research Associates
- Clinical Investigators
- Study Coordinators
- Clinical Quality Assurance Professionals
- Institutional Review Board Professionals
Elizabeth Ronk Nelson, M.P.H.
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