MHRA GCP Compliance Reports

Following on from the away day, I have clarified some points with Jason relating to the MHRA’s request for information about laboratories.

• The request has been sent to 15 non-commercial sponsors, 15 commercial sponsors and 15 CROs so far. The requests are not being sent directly to CTUs, but you may be asked to provide the information via your sponsoring organisation.

• The information to be included in the compliance spread sheet relates to the organisation’s laboratories only. Where third party laboratories are sub-contracted to provide laboratory support, the MHRA have requested that these be listed separately (the email to the sponsor has the request for this list, rather than it being included in the spread sheet).

• If the study protocol lists exploratory assays as primary or secondary endpoints, then the laboratory should be included. However, the exploratory nature of the work can be flagged in the spread sheet/listing (this may reduce the risk score of the laboratory, but naturally, I am not part of the MHRA assessment process, and this is just my understanding). If the exploratory work is not part of the primary or secondary endpoints, the laboratory does not need to be included.

• Routine safety samples would not require the laboratory to be listed, unless the analysis specifically forms part of the primary or secondary objectives/endpoints.

I hope this helps. I will update further if I receive more clarifications/comments.

Simon

 

 

Simon Kerridge
Senior Quality Assurance Manager
Jenner Institute and Oxford Vaccine Group
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE

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