TRIAL MASTER FILE
Files that are established at the investigator site and at the sponsor office(s) at the beginning of the trial containing all of the documents that permit evaluation of the conduct of the trial and the quality of the data produced, and serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and applicable regulatory requirements. Any or all of the documents referred to in ICH E6(R2) and others that are not specifically referred to in this guideline may be subject to, and should be available for, audit or inspection. They are therefore included within the Trial Master Files. The Trial Master Files include the investigator trial master files and the sponsor trial master files. The contents of the investigator Trial Master Files may be held in more than location or filing system. Similarly, the contents of the sponsor Trial Master Files may be held in more than location or filing system.
In the case of a single site, investigator-initiated trial where the investigator is also the sponsor, there will only be one set of Trial Master Files, established and maintained by the investigator.
Establishment and maintenance of Trial Master Files is a mandatory requirement in guideline ICH E6 (R2).
INVESTIGATOR SITE FILE
This is a commonly-used term to refer to the main content of the investigator Trial Master Files , other than the subject or patient’s medical notes (also known as ‘source documents’).
This is an alternative and equivalent term to describe the investigator site file. It contains the main content of the investigator Trial Master Files but does not include source documents that are part of the subject medical file or medical notes.
Documents held within the subject or patient’s medical notes that document the existence of the subject and substantiate the integrity of trial data collected. This includes original documents related to the trial, to medical treatment, and the history of the subject. Source documents are a component of the Trial Master File established and maintained by the investigator. They are typically held in the subject’s medical file(s), in a separate location to the Investigator Site File or Regulatory Binder.
Whilst many of the regulations and guidelines use the term “document”, in almost all cases the term also applies to:
- groups of documents
- parts of documents
- data sets
- system records
- images, files etc
- records held on other media, such as x-rays