DIS 14155 standard available

Some news regarding the upcoming update of the ISO 14155 standard, the draft international standard (DIS) version is now published. It was already known that the ISO 14155 standard that dates from 2011 was under review and an update was upcoming. National authorities now have the opportunity to comment and vote if they agree to proceed to the next phase (FDIS, final draft international standard). Then after the next vote on the FDIS only editorial changes are still possible and the final ISO will be published. In all likelihood, medio 2019. Qserve will keep you up to date as soon as the final ISO 14155 is available. Based on the currently available DIS version the main changes compared to previous edition include: 

reference to registration of the clinical investigation in a publicly accessible data base
inclusion of guidance with regards to clinical quality management
inclusion of risk-based monitoring
inclusion of guidance statistical considerations 
inclusion of guidance for ethics committees 
reinforcement of risk management throughout the process of a clinical investigation (planning to consideration of results)
clarification of applicability of the requirements of this standard to the different clinical development stages 
inclusion of guidance on clinical investigation audits  

For details and training, contact our Clinical team:

Ellen van Kleef, PhD
Peter Oosterhoff
Loes Pelgrim
Wiebe Postma, PhD
Post date: December 07, 2018
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