Overview
Date published: Aug 2014
Core activities: 2 hours
2 CPD points
This course aims to teach researchers:
- The contents of a GCP-compliant protocol
- How to write and review a study protocol
- The other documents essential for the conduct of a clinical study.
Syllabus
- Module 1: Introduction to GCP compliance
- Module 2: Protocol: objectives, design and methodology, eligibility and withdrawal criteria, accountability and safety, data and records, ethics and review
- Module 3: Associated documents: Participant Information Sheet, Consent Form, and Case Report Form
Author: Dr Phaik Yeong Cheah
Head of the Clinical Trials Support Group, Mahidol Oxford Tropical Medicine Research Unit, BangkokReviewer: Sarah Rickard
Network Manager, Greater Manchester, Lancashire and South Cumbria Medicines for Children Research Network