ICR Ethics and GCP Forum: Learnings from MHRA Lead Inspector

Last month the Institute of Clinical Research (ICR) hosted its Spring Ethics and GCP Forum at the prestigious University College London. Arkivum exhibited at the event, which offered a great opportunity for me to speak with delegates and attend several insightful presentations. Among these, one titled “Hot Topics in Inspections” presented by a Lead Senior GCP Inspector from the MHRA, stood out and created significant interest from the approx. 200 attendees. Here, I share some key takeaways:

MHRA’s Aim for Seamless Inspections

The MHRA aims for smooth inspections. It was made very clear that the inspection process should be optimised for efficiency, to ensure a seamless review and assessment. The inspector emphasised the significance of storing electronic Trial Master Files (eTMF) in one location and maintaining consistent file naming conventions, this significantly simplifies the inspector’s task on inspection day.

During the Q&A session, some individuals expressed concerns about varying inspection experiences however, the MHRA commented on their strong commitment to training and upskilling to ensure everyone is well-prepared without experiencing any challenges or obstacles on the day.

Audit Trails: An Inspector’s Trusted Companion

Inspectors keep a close eye on data access. During the presentation it was noted that this was a recurring issue where access rights for departing nurses and doctors are not always being revoked fast enough. This was very much a call to action for the many people in the room. In addition to looking at who has access to the data, it was confirmed that inspectors are also investigating document modifications over time and the reasons behind them, clearly crucial for instilling confidence in the integrity of the data.

The Era of Hybrid Inspections Dawns

The era of in-person inspections is fading into the past. Instead, hybrid inspections are starting to take centre stage, highlighting the “post-Covid” reliance on remote communication platforms like Zoom, Teams, and Skype. Inspectors are now able to conduct interviews and access digital records from a distance, the benefit of the constantly evolving landscape of modern communication. Another supporting factor for hybrid inspections is the user-friendliness of the system where data is archived. Inspectors favour platforms that are intuitive and don’t require extensive training to use. Platforms with features like appropriate access rights (e.g., Read Only) and the ability to only access the data that requires their attention, this streamlines the process and aligns with the efficiency theme as discussed earlier. Ultimately it is important to sponsors and other stakeholders to have the right tools in place to support this shift.

Shifting Away from Paper Records: The Necessity of Digital Transformation

Possibly the main theme which echoed throughout the inspector’s presentation and also from the delegates —the urgency for healthcare organisations to transition from archaic paper-based records to digital systems. The inspector mentioned that this shift is not only preferred by the MHRA due to benefits like audit trails and data integrity, but it’s also favoured by sponsors, allowing for easier access to the data and removing certain challenges presented during in-person inspections (e.g. arranging visitor parking).

It was also mentioned that some NHS Trusts still resort to printing documents during inspections instead of providing digital copies, a practice which is a common setback in assessing data integrity. Following on from the presentation, the conversations that I had during the break really gave me a sense of the amount of pressure NHS Trusts have to embrace digitalisation, within achievable budgets, not only to align with guidelines from the MHRA but also to free up physical space. I wrote about this very popular topic earlier this year in a blog titled “Beyond Paper: Ensuring Long-Term Preservation of Healthcare Records & Data”, more information on this can be found here.

Keeping Pace with Technological Advancements

Following the topic of “Digitalisation” the inspector made it very clear to everyone that both media and systems can degrade over several years and the important thing is to be mindful on how we manage electronic data over time. This is a topic which is also highlighted frequently by Arkivum and it was very clear during the inspectors presentation that by simply overlooking this, it can cause issues on the day of inspection, slowing down the whole process.

Conclusion

The ICR’s Spring Event was an enlightening experience, helping everyone view inspections through the eyes of the inspector. Not only did it provide insight into the challenges that the MHRA come across, but it also confirmed the active steps people need to take to avoid them. We also had a glance of the future direction of inspections, where communication platforms and digitalised data support hybrid inspections making the process much more efficient, benefiting both the MHRA and NHS Trusts.