GCP for Investigators: Clinical Investigation Close out or Termination
In this course we will review under what circumstances a clinical investigation may need to be suspended or prematurely terminated and the role of each party involved. We will further outline all major activities required in order to close a clinical investigation, including all necessary reporting to sponsor, ethics committee or IRB and competent authority or FDA.
This course has been developed according to the requirements outlined in:
- ISO 14155:2011 – Clinical Investigation of medical devices for human subjects – Good clinical practice
- 21 CRF part 812 – Investigational device exemption
- Declaration of Helsinki
- 21 CRF part 50 – Protection of Human Subjects.
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Upon completion of this course, trainees will be able to correctly and successfully:
- Perform the appropriate actions when a suspension or premature termination of a clinical investigation is needed and/or perform all close out activities necessary at the end of a clinical investigation.
Principal and co-investigators, study coordinators, site managers, and other hospital staff or ancillary staff involved in the clinical side of a medical device clinical investigation.
Learners must have an understanding of what a clinical investigation is about and a basic understanding of the medical device regulatory and good clinical practices environment. Introduction to medical devices (ID 193), how to qualify for a medical device clinical investigation (ID 200), ethics and legal processes (ID 212), initiating a clinical investigation (ID 202), and conduct of and reporting during a clinical investigation (ID 204) provide the pre-requisite knowhow.