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Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA

Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last year. The change in data and trial types and thereby the use of computerised systems presents new challenges.

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.

This guideline is intended to assist the sponsors, investigators, and other parties involved in clinical trials in complying with the requirements of the current legislation (Directive 2001/20/EC and Directive 310 2005/28/EC), as well as ICH E6 Good Clinical Practice (GCP) Guideline (‘ICH-GCP guideline’), regarding the use of computerised systems and collection of electronic data in clinical trials.

The guideline applies to the legal representatives and CROs, which according to the ICH-GCP guideline includes any contracted party such as vendors and service providers to the extent of their assumed trial-related duties and functions.

The guideline was released on 10-June-2021

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