Recently I attended the bi-annual meeting organised by the Institute of Clinical Research – GCP Forum. We had the pleasure to have the senior GCP inspector at the MHRA, Andrew Fisher, with us who did a great overview of the latest GCP findings from the MHRA inspections.

As someone who works remotely, I was very interested to learn how the remote inspections are facilitated. It seems MHRA are facing similar issues like many of us with the remote access to electronic medical records. While some hospitals have made it very easy and straightforward, others have created a lot of complexities like sponsors having to pay £200 for monitor access card. Actually, this is something that could prevent companies from using such hospitals for conducting clinical trials.

I found the presentation on the GCP findings very insightful as I have seen these challenges in our daily work. Here is a short list of them.

  1. Reference Safety Information (RSI)

RSI is not updated regularly which results in underreporting safety information. Sometimes the issue is with having multiple Investigator Brochures (IB) submitted in different counties which are not reconciled.

  • Protocol Amendments Implementation

This is, indeed, a challenge for all clinical trials in the UK. Before a protocol amendment is implemented it has to be approved by local R&D teams in the hospitals and these approvals come in effect at different times. This is why often it is not clear when the amendment is implemented. Also different hospitals have different approach to non-substantial amendments – some issue acknowledgement while others don’t.

  • Informed Consent

There were issues observed especially during the pandemic where patients were not consented because they were inpatient and then they were discharged or when their relatives were consented but then the patients were not reconsented when there was an opportunity for that.

  • Patient Confidentiality

Issues were observed in decentralised clinical trials where identifiable patient information was sent to the CRO.

  • Principal Investigator (PI) Oversight

The first issue that was raised is that often the information required to confirm patient eligibility is collected during different timepoints and the physicians have signed eligibility worksheet confirming patient is eligible before having all the information.

Another issue is the access to safety reports as not all sponsor portals where physicians can access safety information have a proper audit trial.

  • Risk Assessment

These types of issues were observed when there are some major changes in the clinical trial and there was no adequate risk assessment. This was particularly true during pandemic period when there were drastic changes in the study designs to facilitate any new health recommendations.

Another important question which I raised during the discussion part is about hospital systems validations and what is expected from the sponsors. This question has been a subject to discussions over the years, and it was great to learn where MHRA stands. Apparently, there will be a special advice on this which is currently prepared, but what was made clear was that sponsors have to assure that the hospital medical records are fit for purpose and have adequate audit trial. The responsibilities for validation and maintenance lay with the hospital.

Author: Olga Peycheva

Published: 23 April 2024