Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”.  This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator.  Many of the computerised systems used during a trial are only used during the active data collection stage of the trial, which is often a shorter period of time than the retention period required for the archiving of the essential documents of the trial.

The position paper discusses the needs and proposed practical directions for archiving of clinical research. The task force has included representatives the pharmaceutical industry, investigator and institution sites, contract research organisations and vendors of computerised systems to the clinical trial industry.  The paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.

The position paper is the product of unparalleled knowledge and experience, and nearly three years of continuous efforts by  the EUCROF and eClinical Forum Joint Task Force on Archiving and Decommissioning.