The MHRA GCP Inspectors provided insight in their experience during the COVID-19 Pandemic. Although they have their limitations, remote GCP inspections have proven to be very effective and critical findings have been identified.
GCP Inspector´s Experience of Clinical Trials during the COVID-19 Pandemic
A Risk-based Approach to Protocol Deviations As patients were not coming for visits as planned by the protocol, ongoing trials had to use different methods to get Investigational Medicinal Products (IMPs) to participants. In many cases this meant sending IMPs directly to patients’ homes. Therefore, the agency advised that minor protocol deviations should be identified, and these could be documented at a trial level, rather than an individual level. For example, trial-level file notes can be used to document participant visits that were performed remotely, and IMP that was delivered directly to homes where this was not originally intended. A risk-based approach is taken to the documentation of protocol deviations: Deviations that impact on participant safety and the reliability of results should be identified, documented and considered when the data are analyzed.
Remote Source Data Verification (SDV) Remote access to electronic Health Records (eHRs) is something the agency addressed to facilitate SDV and monitoring. Consideration must be given to where this access takes place. For example, will CRAs (Clinical Research Associates) be accessing records in an open plan office, public space or other location where others who are not authorized could view sensitive information? Thus, the agency has published guidance for access to eHRs remotely following consultation with stakeholders and vendors who design and build these systems.
Experience with Remote Inspections The MHRA has identified critical findings on remote inspections. Although they have their limitations, remote inspections have proven to be very effective. According to the agency, remote inspections "work well for focussed inspections, for example follow-up to specific issues or a CAPA review, or those that are very data orientated". During the ongoing pandemic it became apparent that there would be a significant effect on the amount of data that could be collected from ongoing trials. "With patient visits limited, the data collected was less and depending on the criticality of that data, this could mean that the trial objectives may not be met". Remote inspections allowed maintaining oversight. However, these inspections require a lot of document review, with less interaction and a limited review of facilities. Finally, the MHRA says that "it takes a lot longer to conduct a remote inspection, we may not have to spend so much time travelling, but the time spent accessing, requesting, reviewing and cross-checking documents, asking questions, is much longer than we anticipated".
More information can be found in MHRA´s Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1,Part 2, Part 3).