What you’ll learn
- This course will look at the purpose of Essential Documents. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and with all applicable regulatory requirements.
- This course is for anyone woking with clinical research or with a keen interest.
This comprehensive course for Essential Documents will give you all the required information you need regarding documentation required for the conduct of a clinical trial. This course will cover
Define Essential Documents and their purpose
Understand what ICH GCP E6 R2 says about Essential Documents
Investigate eTMF systems and their place in accurate storage and retrieval of Essential Documents
Understand how to archive Essential Documents according to ICH GCP standards