LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

 

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ECF Teams and Projects

Archiving and Decommissioning

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.

The EMA plans to release an eSystems Guideline (to replace the EMA Source Reflection Paper)  by the end of 2019 

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