The MHRA’s annual inspections report reveals multiple serious issues involving data protection and even one lethal overdose.
The MHRA’s GCP inspectorate has just published its findings for the year ending 31st March 2011. During the period, a total of 161 GCP Inspections were undertaken by the MHRA GCP Inspectorate – comprising non-commercial sponsors, commercial sponsors, Universities, NHS Trusts and one charitable organisation.
The most serious findings include –
- A sponsor who put subject names in the SAE reports and drug accountability logs in the TMF
- A CRO passing source documentation with subject names to the sponsor
- The same CRO manufacturing an IMP without a licence
- A university with inadequate oversight of trials – including failure to implement a trials monitoring system and failure to follow new R&D procedures
- Another university who had failed to properly implement risk assessment, insurance assessment and updates to existing trials to ensure compliance.
One inspection of an NHS trust found “clear evidence of the failure of the Trust to have effective systems in place to ensure compliance with regulations and in particular with the principles of GCP.”
The most tragic error was found when inspecting an investigator site. The IMP had been so poorly labelled that a patient mistakenly took an overdose and died. This is despite issues being reported to the sponsor, who was responsible for labelling.
This makes especially depressing reading to a supplier of GCP, GMP and pharmacovigilance training. Online training can be taken whenever and wherever the learner wants so there’s no good reason not to be fully up to speed.
It is the responsibility of everyone running trials to make sure the unavoidable risks are controlled and minimised. I can’t help thinking that with more focus on the principles of good practice, these findings could have been so much better.
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