This is a professionally developed, interactive and engaging online Essential Documents training course. It will provide an overview of essential documents, including which stage of the Clinical Trial process they will normally be generated. This course has been updated in 2022 to ensure all current Regulations are covered.
This course is suitable for anyone carrying out or involved in clinical research who needs to gain knowledge of essential documents and an understanding of their importance during each stage of a clinical trial.
- 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