Notice to Sponsors on Validation and Qualification of Computerised Systems Used in Clinical Trials

On 7 April 2020 the EMA provided guidance in forms of questions and answers (Q&As) on GCP.

EMA has published a notice for clinical trial sponsors to highlight the requirements for the qualification and validation of computerised systems used for managing clinical trial data. This is based on inspection findings and taking into account implications on the integrity, reliability, robustness and acceptability of data in marketing authorisation applications.

Read the pdf Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /