This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas. 

Facilitators:   Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)

We will be discussing a recent eCF/EUCROF positions paper: 

The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.  You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)