Trial Management Documents

Files need to be prepared for storing the essential documents for a clinical trial. A Trial Master File (TMF) is held by the Sponsor and Investigator Site Files (ISF) are held at sites participating in the trial. The ISF can be hard copy or in an electronic format. If the trial is using a drug, then a Pharmacy File is used to ensure appropriate records of the trial drug are kept.

Essential documentation such as personnel delegation and training logs should be completed along with any other necessary information provided to the Sponsor for the trial to be able to commence recruitment at the site. Essential documents assist with the conduct of the study and ICH GCP has established a list of essential documents that you should maintain throughout the lifecycle of your study:

  • Before the clinical phase of the trial commences
  • During the clinical conduct of the trial
  • After completion or termination of the trial

Essential documents may be inspected by regulatory authorities or Sponsors to confirm the validity of the trial conduct and the integrity of the data. A final close-out of a study can only be done once all necessary essential documents are confirmed as filed.

If you use an electronic method of storage for essential documents, for example a Clinical Trial Management System, it is important that the system provides for document identification, version history, search, and retrieval.


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