GCP Inspections Metrics Report

On 12 February 2021 the MHRA GCP Inspectorate issued the GCP inspections metrics report covering 1 April 2018 to 31 March 2019.

During the metrics period, a total of 91 GCP Inspections were undertaken by the MHRA GCP Inspectorate. Reports relating only to the inspections carried out and completed in the metrics period were reviewed. It is important to note that multiple inspections can be reported in one GCP Inspection Report. For example, a commercial sponsor GCP Inspection Report may consist of the sponsor inspection and associated investigator site inspections.

A total of 8 commercial sponsors were inspected, and all have been reported. Out of the 8 total inspections, 4 (50%) had at least one critical finding and all (100%) had at least one major and/or critical finding. There were 7 critical findings from 4 organizations. A total of 11 CROs were inspected and a total of 9 GCP inspection reports from the 11 inspections during the metrics period. All 11 of these inspections were systems inspections. Of the 9 GCP inspection reports, 4 (40.0 %) had critical findings and 9 (90.0%) had at least one major finding. There were 6 critical findings from 4 organizations.

Out of the 12 non-commercial organizations inspected, 11 have been reported. Of the 11 GCP inspection reports, 2 (16.7%) had at least one critical finding and 8 (66.7%) had at least one major and/or critical finding. There were 3 critical findings identified from 2 organizations. A total of 7 inspections were done of Commercial Phase 1 Units/Clinical Research Units, 6 were reported. There were no critical findings. A total of 19 investigator sites in the UK were inspected. The summary of findings is based on 21 inspections. Of the 21 reported inspections, 1 (4.8%) had a critical finding and 13 (61.9%) had at least one major finding. There were 2 critical findings for 1 investigator site.

The observed critical findings were related to Pharmacovigilance, Record Keeping/Essential Documents, Clinical Trial Authorization, Protocol Compliance, Data Integrity Control Processes, Patient Safety, Dose Escalation, Trial Management, GCP compliance, Data Integrity.

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