I attended the annual UKCRC QA away day which was held on Friday the 24th Nov 2017, at the University of Liverpool in London, Finsbury Square (London). The day was very well organised, informative and a huge opportunity to network with other QA professionals working in our field including the Senior MHRA GCP Inspector Jason Wakelin-Smith (JWS) who spent the whole day with us answering questions and who also gave us a talk. The day focussed on the following topics:
1. Update by QA group on guidance documents
2. MHRA GCP Laboratory Inspection
3. MHRA General GCP Inspection
4. MHRA IT Inspection
5. NHS Digital Audit
6. Very brief summary of where we are with the EU Clinical Trial Regulation
JWS gave us a talk on the GCP Inspection of laboratories involved in the analysis of samples that inform the primary and/or secondary endpoint of a CTIMP. It was clear that accredited laboratories embedded within the NHS will now be included in the inspection and are not exempt as previously thought, making the point of how do staff know that samples come from clinical trial subjects. We were also reminded that GCP is not GLP and is not GCLP, infact there is no such standard as GCLP. We are also expecting a new guidance document on how to work with laboratories involved in the analysis of samples that inform tertiary end-points, especially if results from these studies inform the design of a new trial. We also had a talk from the Sponsor representative at the University of Leeds who shared with us their experience of a recent MHRA GCP laboratory inspection. We are hoping to invite her to come to Oxford to give us a seminar and for this I strongly suggest we invite all of our CIs involved in such studies.
We then had a session from Sharon Kean, Director of Information Systems, Robertson Centre for Biostatistics, Glasgow with regards to their recent MHRA IT Inspection. We have a copy of the questions asked during that inspection and we in OCTRU are in the process of self-assessment to go through these same questions and identify any gaps where we may have shortcomings in this area. At this meeting JWS emphasised the need for QA involvement in IT.
We also had a talk by April Lockyer who is Head of Research Governance, Ethics and Integrity from the University of Manchester who had experienced a recent NHS Digital Audit. Unlike MHRA GCP Inspection reports, any audit report from the NHS Digital Audit programme is published on-line.
The final session was a quick update as to where we are with the implementation of the EU Clinical Trial Regulation (now deferred to 2019 and still not clear if the UK will embrace the Regulation as the timing is such that BREXIT would have happened by then). But we were reminded that the General Data Protection Regulation (GDPR) will kick in in May 2018 and it will repeal the current Data Protection Act and as a result our SOPs that refer to the DPA will need to be revised accordingly.