Webinar Topic
Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials
Webinar Date & Time
20 October from 03:00 PM to 04:30 PM (CEST)
Webinar Overview
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 EUCROF and the eClinical Forum to formulate a position paper discussing the needs and proposed practical directions for archiving of clinical research.
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:
EUCROF – https://www.eucrof.eu/publications
eClinical Forum – https://eclinicalforum.org/en-us/Downloads
The position paper has been written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO eConsortium, Medicines for Europe and the RQA. The task force has included representatives from the pharmaceutical industry, investigator and institution sites, contract research organisations and vendors of computerised systems to the clinical trial industry.
Presenters
Dr Dagmar Chase
GCP Consultant and Trainer, Clinrex Munich (Germany).
Dagmar Chase graduated in Computer Science with a secondary focus on Theoretical Medicine from the Technical University in Munich and has a PhD in Human Biology from the Medical Faculty of the University in Ulm, Germany. Dagmar Chase co-founded the company GMI, a full service CRO for clinical trials phase II – IV, in 1983. Besides developing GMI into one of the largest CROs in Germany, she concentrated on Quality Management as well as the development of training programs for the pharmaceutical industry. After the merger of GMI with the US-based CRO Kendle International Inc in 1997 (now Syneos Health), she held the position of vice president until the beginning of 2004. In March 2004, Dagmar Chase started up Clinrex, a consultancy firm for clinical research. Dagmar Chase is a co-founder of the German CRO association BVMA e.V. which was established in 1991. She was president of the BVMA from 2001 until the end of 2017. Dr. Chase is also a co-founder of EUCROF, the European CRO Federation, and held the position of vice-president for 10 years until the end of 2016. In 2019, the BPI e.V. appointed Dagmar Chase “BPI Senior Expert” in recognition of her knowledge and expertise in clinical research and GCP.
Mr Alan Yeomans
Regulatory Affairs Manager, Viedoc Technologies AB
Alan Yeomans has worked with the development of computerised systems for 40 years as hardware designer, programmer, system architect, project manager and in a number of management roles including CTO and QM.
Alan has been Quality Manager for Viedoc Technologies since late 2008, where he is responsible for Quality Assurance of their EDC vendor business. From 2008-2014 he was also the Quality Manager for their CRO business, until that part of the company was organised as a separate entity. Alan has earlier worked as CTO for a Swedish CRO (CDC) and as CTO and QM for an international ePRO provider (Clinitrac).
Alan graduated with a Bachelor of Engineering (Electronics) from the University of Western Australia in 1980 and studied Control Systems at the Imperial College (London) in 1983.
Alan worked at British Aerospace, Space and Communications Division from 1981 to 1984 as a hardware designer on control systems for communications satellites. While there he developed the first CPU-board used in control systems on their communications satellites.
After moving to Sweden in 1984 Alan started working with software development, starting with hardware driver routines and moving up through the software architecture to all levels, including user interface software and database software.
Alan has worked with the use of electronic data in clinical research since the year 2000, and he has worked in the following international groups aimed at promoting the use of electronic data for clinical research:
- EHRCR Project – EU Team Leader (internal eClinical Forum project)
- EHR4CR Project – Member of User Scenario Task Team (EU project)
- eSource Task Group – Technical Stream Team Leader (internal eClinical Forum project)
- REG - Regulatory Expert Group – Co-chairman (internal eClinical Forum project)
- NTWG – New Technologies Working Group – Chairman (internal EUCROF work group)
- eDigital Team - member (internal ACDM group)
Alan is a member of RQA (the Research Quality Association), eCF (the eClinical Forum), EUCROF (the EU CRO Federation) and ACDM (the Association for Clinical Data Management).
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
19 October 2021
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