Is Your eSystem Actually an eCRF (electronic Case Report Form)?

On 11 May 2021 the MHRA Inspectorate published this blog.

With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA Good Clinical Practice (GCP) inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind. This is because some of these systems are a mechanism to report protocol-required clinical data to the sponsor and are therefore acting as an electronic case report form (eCRF), yet do not have the same functional requirements for an eCRF to meet International Council for Harmonisation (ICH) GCP expectations and ensure data integrity.

The different systems used to collect clinical trial data should be mapped out and the data flow should be defined, in particular the identification and location of source and transcribed data.

The functionalities of such systems should permit data changes and authorisations by the investigator with a clear audit trail to verify the integrity of the trial data and to explain why the data was amended.

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