#Barnett
Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.
Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).
Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.
Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.
Archive: Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
Course Description
Both the 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.
Video Preview
Learning Objectives
- 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
Who Should Attend
- Project Managers
- Clinical Research Associate Managers
- Clinical Research Associates
- Clinical Investigators
- Study Coordinators
- Clinical Quality Assurance Professionals
- Institutional Review Board Professionals
Instructor
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer biographies
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.