Скачать или смотреть GCP for Investigators: Initiation of a Medical Device Clinical Investigation

Course Description:

In this course we will review how the investigator and his/her team should prepare for an initiation visit and how to actively participate in the site initiation visit activities in order to get your investigation site organized to be fully operational and compliant to the Clinical Investigation Plan (CIP), Good Clinical Practices (GCP) and applicable regulations following the Initiation Visit.

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...