Here is the course module for Essential Documents.
When you are ready to begin click, “Launch Module” and it will open in a new window.
Once you have completed this module, you can close down the window and you will be automatically be directed back to the main course page where you can print your certificate.
Covered in this module:
- Defining essential documents and their purpose
- Types of essential documents
- Essential documents before, during and after a Clinical Trial
- ICH GCP E6 R2 and its requirements in regards to essential documents.
- The purpose of the Trial Master File (TMF)
- eTMF systems and their place in accurate storage and retrieval of essential documents
- The roles and responsibilities of a monitor, sponsor and investigator regarding essential documents
- How to archive essential documents according to ICH GCP standards
