Welcome to our comprehensive guide on the informed consent process in clinical trials, based on FDA guidelines. This video is designed to help new clinical research professionals understand the essential elements and responsibilities involved in obtaining informed consent from participants.
Timestamps-
00:00- 01:59 – Introduction
04:48 – General consideration
07:58 – Advertising research
In this video, we cover:
– The overall informed consent process
– The role of ethics committees and investigators
– Key considerations and requirements for informed consent
– The importance of clear communication and participant rights
– Relevant CFR codes and regulations
– Best practices for advertising clinical trials
Supporting documents
1) Session notes- https://drive.google.com/file/d/1whKIJIQ6aexJrJ1YJ0iX-JhJv4Y-A7Cb/view?usp=sharing
2) Reference file – https://www.fda.gov/media/88915/download
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