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Role of inspections

Posted by bedwards138 on 08 Mar 2018 at 18:18 GMT

It is worth noting that as far as I am aware recording of clinical trials is not part of a routine GCP inspection for either US FDA or any EU authority. Certainly quality checks by inspectors do not occur. Not aware that they are part of a sponsor GCP audit program routinely . Maybe the authors would care to raise this with the relevant authorities to see whether that might help improve the quality of registration?

No competing interests declared.