Birds-of-a-Feather Webinar:  Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

Date:  11-January-2022      Duration: One hour

Presenters:   Dr. Dagmar Chase, Clinrex Munich, GCP Consultant and Trainer

                      Alan Yeomans, Regulatory Affairs Manager, Viedoc Technologies AB

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic:  The archiving of clinical trial records is a required process that is in need of future direction to meet current business models as well as regulatory and legal expectations.  A group of industry experts coalesced under the eClinical Forum and EUCROF, with other industry associations including ECRIN, the ePRO eConsortium, Medicines for Europe and the RQA  to formulate a position paper discussing the needs and proposed practical directions for archiving of clinical research. The task force included representatives from the pharmaceutical industry, investigator and institution sites, contract research organisations and vendors of computerised systems to the clinical trial industry.

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.

This position paper highlights 11 key positions about archiving given the distributed nature of the TMF, and the archiving of data from computerised systems to allow those systems to be decommissioned when they are no longer required in the trial. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices. The paper can be downloaded from: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)

Time – this webinar is offered at 2 times, both on 11-Jan-2022. We hope you will find one of them convenient for your participation, however the webinar will also be recorded and you can register to receive the recording.

Webinar A: Europe/Asia Pacific facing:

Webinar B: Americas/Europe facing:

THOSE FROM ECF MEMBER COMPANIES MAY FOLLOW THIS LINK TO REGISTER:   Webinar Registration (eclinicalforum.org)

Not from an eCF Member company? Ask us about becoming a member: info@eclinicalforum.org