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 TMF and 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.

TRIAL GUIDELINES

Guidelines and/or user manuals are required to instruct clinical trial staff on operational aspects of clinical trial management, e.g. collection and entry of trial data; receipt, storage and handling of investigational drugs; collection, processing and storage of biological specimens.

For example:

• A pharmacy manual, to guide how a medicine is stored and managed by the Trial Pharmacy
• A laboratory manual, to guide how biospecimens to be used for translational research are collected, processed, stored and managed.

You and the Sponsor should also determine how the trial should be monitored and this should be documented in the monitoring plan in the protocol.