Скачать или смотреть GCP for Investigators: Clinical Investigation Close out or Termination

Course Description:

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.

Learn more at: http://www.wmdo.org/course-detail.asp...