May I canvass the opinions of mailbase users concerning the guidance issued
by the MHRA "......on the maintenance of regulatory compliance in laboratories
that perform the analysis or evaluation of clinical trial samples."
I have the impression that this addresses the proper running of laboratories
where clinical research is ongoing but not to diagnostic labs where routine
testing is an adjunct to the apraisal of patients participating in clinical trials. I
have sought guidance on this question in the past and was assured that CPA
accredited labs were demonstrably providing services to the appropriate
national quality standard. What do you think?
Regards,
David
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