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Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

In May of 2018 the EMA invited 12 representatives from industry to discuss technical issues concerning the use of computerised systems for clinical research, including representatives of EUCROF and the eClinical Forum.

EUCROF and the eClinical Forum decided to collaborate on a position paper describing industry best practices and recommendations on several topics. An invitation to participate was then extended to all other representatives from industry who had participated in the meeting with the EMA and the majority of them have decided to collaborate on the position paper either as co-authors or as reviewers. One of the primary focuses is Archiving and Decommissioning.This group met again with the EMA in June 2019.

They have now published 3 outstanding papers that have contributed greatly to this discussion within the industry:  Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team (eclinicalforum.org)

The team is now sunsetting until further need is assessed.

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Categories: Archiving and Decommissioning, TEAMS STATUS and TYPE, Active, Working GroupNumber of views: 3076

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