Storage and filing of essential documents (Trial Master File) in connection with clinical trials

The essential documents concerning a clinical trial must be available for inspection

A Trial Master File for a clinical trial must contain all documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. Based on the Trial Master File, the Danish Medicines Agency must be able to control if the sponsor, investigator and other involved parties have ensured that the trial meets the good clinical practice (GCP) requirements.

The Trial Master File must be established from the onset of the trial and kept updated on an ongoing basis as the trial completes different stages. The Danish executive order on GCP contains a minimum list of documents generated before, during and after the trial, which must be stored in the Trial Master File with the sponsor and investigator, respectively.

Based on deviations observed in several inspections, the Danish Medicines Agency would like to point out that e-mails concerning the trial are also considered part of the Trial Master File.

If certain documents are assessed not to be of relevance to the Trial Master File, the Trial Master File must include a reason for omitting these documents – in a timely manner.

If an electronic Trial Master File is used, please note that the GCP Inspectors' Working Group in the EMA have adopted a Q&A document on this topic. The document will be published on EMA's website.

Storage period

The text from Directive 2005/28/EC has been implemented into Danish legislation in the form of the executive order on GCP, which became effective on 8 July 2006. The executive order lays down that sponsor and investigator must ensure that all significant documents concerning the trial (the Trial Master File) must be stored for at least 5 years after completion of the trial. The documents must be stored longer than this, if any other legislation so requires, e.g. if the trial results are to be used in connection with an application for a marketing authorisation for a medicinal product, or if this is agreed with the sponsor.

Storage conditions

The executive order on GCP stipulates that the media used for storage of documents etc. must be stored appropriately and must be protected from loss and damage in the required storage period. Likewise, the executive order stipulates that any changes to the documents etc. must be documented. In addition, the sponsor and investigator must ensure that the documents are stored in a manner that makes them easily available for control.