Previously submitted to: JMIR Medical Informatics (no longer under consideration since Sep 24, 2025)
Date Submitted: Jan 8, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Enhancing Regulatory Compliance in Research Electronic Data Capture (REDCap): the MHRAFix external module
ABSTRACT
Background:
Nearly every clinical trial that takes place makes use of electronic data collection (EDC) to ensure that data is collected in a secure and transparent manner. It is essential that all electronic data collection systems comply with the appropriate regulations, and in 2021 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published a blog article titled “Is your eSystem actually an eCRF (electronic case report form)?” highlighting areas in which many electronic data collection systems were not complying with the existing regulations. Following a review of the REDCap data collection system used by the a large UK based academic Clinical Trials Unit(CTU) an extension to REDCap has been written to address these areas of non-compliance.
Objective:
Create and implement an external module for the Research Electronic Data Capture system to provide additional compliance to regulatory agency expectations.
Methods:
An extension has been written using the inbuilt external modules feature within REDCap. This extension adds to the existing functionality to provide “Default reasons for change”, “Real time data saving”, “Enhanced review of data changes” and “Modified form editing rights” to ensure compliance with the issues identified in the 2021 MHRA blog.
Results:
An external module for REDCap has been produced to aid in ensuring REDCap’s compliance with GCP.
Conclusions:
Whilst the direct replication of processes that are utilised when collecting data on paper CRFs and then transferring that data to an EDC is beyond the scope of this paper, it is important to note that at the heart of the 2021 MHRA blog [1] is the desire to ensure that there is complete transparency and a clear understanding of changes to data as it is collected. This module builds upon REDCap's core functionality to allow system users to comply with the principles of GCP as per the expectations raised in the cited article from the MHRA, which should reassure the competent authorities on the suitability of REDCap for use in clinical trials, especially in the academic setting.
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