Study Documentation

The EMA Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials (Read the full paper EMA/INS/GCP/636736/2012) defines the minimum time the sponsor and investigator need to retain the essential documents relating to a clinical trial. The duration varies by situation and member state.

Trial master files (TMF) should be established at the beginning of the trial, both at the investigator/institution site and at the sponsor's office. A TMF is the collection of documentation that allows the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with GCP to be evaluated (monitoring by the sponsor (audits) and inspection by member states). The TMF is normally composed of a sponsor TMF, held by the sponsor organisation, and an investigator TMF held by the investigator(s). The TMF kept by the investigator and that kept by the sponsor may have a different content if this is justified by the different nature of the responsibilities of the investigator and the sponsor. The sponsor needs to make sure that no documents in the TMF contain information that could be used to identify the participant.

The sponsor's TMF contains:

• The ‘study file’ - this includes all of the sponsor’s documents.
• The ‘site file’ - this is documentation that demonstrates the sponsor’s involvement in getting study authorisation for the site and overseeing the trial activities.

For every investigator site, the sponsor collects a copy of all documents in the ‘Investigator Site File’ (ISF), with exception of those that contain patient identifying information. The ISF is kept at the investigator’s site.

You can download an excerpt from the minimum list of essential documents (for a TMF) in section 8 ICH-GCP guideline. Access the complete list.

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

A description is given of the purpose of each document, and whether it should be filed in either the investigator/institution or sponsor files, or both.