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Draft guideline on computerised systems and electronic ...

Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 10 June 2021 1 EMA/226170/2021 2 Good clinical Practice Inspectors Working Group (GCP IWG) 3 guideline on computerised systems and electronic data in 4 clinical trials 5 Draft 6 Adopted by GCP IWG for release for consultation 4 March 2021 Start of public consultation 18 June 2021 End of consultation (deadline for comments) 17 December 2021 Date for coming into effect TBC 7 8 This guideline replaces Reflection paper on expectations for electronic source data and data 9 transcribed to electronic data collection tools in clinical trials (EMA/INS/GCP/454280/2010).

128 extent that a CRO has assumed the trial related duties and functions of a sponsor (ICH-GCP 5.2.4). 129 When a computerised system is implemented by the institution where the investigator is conducting a 130 clinical trial, any reference to the investigator in this guideline also includes that institution, as provided

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