EMA - Guideline on computerised systems and electronic data in clinical trials

30th June 2021

RQA is collating responses to the EMA’s public consultation on the EMA “Guideline on computerised systems and electronic data in clinical trials

Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last years from eCRF, ePROs, to various wearable devices used to continuously monitor trial participants for clinically relevant parameters and ultimately to the use of AI.

The scope of this guideline is computerised systems, (including instruments, software and services) used in clinical trials in the creation/capture of electronic clinical data and to the control of other processes in the conduct of a clinical trial of investigational medicinal products.

Comments should be provided using this template and sent to camelia.mihaescu@ema.europa.eu by 17 December 2021, with a copy to awilkinson@therqa.com.’

 

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