Propositions on
Remote Source Data Verification and
Remote Source Data Review
A Proposition Paper from EUCROF’s rSDV/rSDR Task Force
The EUCROF rSDV/rSDR task force has released a newly updated version of the Propositions Paper for rSDV/rSDR (remote source data verification and review). The new version (March 2023) has been reviewed by external stakeholders and integrates updated industry and regulatory thinking. The intent of the paper is to open up dialogue to stimulate greater adoption of remote monitoring in Europe. A total of eight propositions are presented in the paper, including on-site and remote monitoring, security and confidentiality standards, service provider eligibility and site acceptance and adherence, and finally, a proposition for a more harmonised approach in the EU and beyond.
