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2,951 students
Essential Documentation within Clinical Research
An introductory course into Essential Documents required for the conduct of a clinical trial
Created byLinda Hopkinson
Last updated 3/2020
English
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.
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Course content
5 sections • 6 lectures • 32m total length
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.