Webinar Topic
Traceability in Clinical Trials: Challenges of the new EU TMF/eTMF Guideline
Webinar Date & Time
28 April 2020 from 10:00 AM to 11:30 AM (CEST)
Webinar Overview
Since June 2019, a new EU Guideline on paper and electronic Trial Master File (TMF) is in effect. The Guideline offers clarifications in many aspects. For example, the requirements on electronic TMFs (eTMFs) are clearly stipulated and the essential documents listed in ICH-GCP are supplemented by additional important documents. Emphasis is given to the interface between sponsors and CROs by providing many elements that should be present in either contractual agreements or other documents that describe the cooperation between the parties. Sponsor oversight duties are well explained, so are the responsibilities of investigators. The structure of a TMF is presented by introducing a primary TMF plus other parts of the TMF which belong to central systems. A TMF is clearly following a decentralized structure which poses challenges to all involved parties of a clinical trials. Last but not least, retention of essential documents is covered and requires the archiving of data in such a way that the data are maintained either in the original system, an emulated system or are migrated to a new system. Static data are not acceptable. Are we really able to fulfill these requirements?
This webinar offers an overview of the EU Guideline on TMF/eTMF and familiarizes the audience with the important topic of traceability in clinical trials. The webinar encompasses the building of the TMF in the right structure, making it available when necessary and archiving it in such a way that inspectors will be satisfied.
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.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
27 April 2020
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