Essential Documentation within Clinical Research

An introductory course into Essential Documents required for the conduct of a clinical trial

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

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..

Course Content

  • Introduction.
  • 2) Defining and Understanding Essential Documents.
  • 3) Clinical trial Masterfile (part 1).
  • 5) Summary.
  • 6) Bonus Content.

Essential Documentation within Clinical Research

Requirements

  • This course is for anyone woking with clinical research or with a keen interest..
Description

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

Who this course is for:
  • This course is for anyone woking with clinical research or with a keen interest.
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