Good Clinical Practice (GCP) inspections and how they are conducted has evolved massively over the years and has had to, due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology.
No longer are clinical trial teams based in one office with a paper trial master file (TMF).
GCP inspections can be challenging for all involved and issues have often been encountered during the inspection conduct to do with TMF access and navigation, document request provision and sometimes simply finding the right person to answer a particular question. This is why the MHRA Inspectorate has released updated information on what should you expect from a routine statutory GCP systems inspection, and what can you do to ensure the inspection goes smoothly.
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