Regulatory Reports

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MHRA GCP Inspection No: INSP GCP 13605/19486-0003 - Corrective And Preventative Action Plan (CAPA).

Inspection Date: 9th – 12th June 2014

Background Information: Plymouth Hospitals NHS Trust (PHNT) has collaborated with Peninsula Clinical Trials Unit (PenCTU) since its registration in 2007 as a UK Clinical Research Collaboration registered Clinical Trials Unit.  For Drug and Device studies the R&D Dept. strongly encourages the use of the PenCTU.  They are based in the Tamar Science Park alongside the Trust R&D office.  They are able to supply project management, data management and monitoring services for studies.  Although 3 of the 4 studies reviewed on this inspection made use of PenCTU, the clinical trials unit was not within the scope of this inspection.

This was the third inspection of PHNT.  A routine systems inspection was conducted in Nov 2009, where there were five major findings.  The CAPA was reviewed at this inspection, and with the exception of Sponsor Oversight, these issues had been addressed.  A further triggered inspection was conducted in Feb 2011 in relation to the ATACAS trial, which raised issues in relation to IMP that impacted on data integrity, pharmacy and authorisations.  This trial was not reviewed again at this inspection.

Definitions of Findings

Critical:

a) Where evidence exists that significant and unjustified departure(s) from applicable legislative requirements has occurred with evidence that:

the safety or well-being of trial subjects either has been or has significant potential to be jeopardised, and/or 
the clinical trial data are unreliable and/or 
there are a number of Major non-compliances (defined in (d) and (e)) across areas of responsibility, indicating a systematic quality assurance failure, and/or 
b) Where inappropriate, insufficient or untimely corrective action has taken place regarding previously reported Major non-compliances (defined in (d) and (e))

c) Where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the Regulations

Major:

d) A non-critical finding where evidence exists that a significant and unjustified departure from applicable legislative requirements has occurred that may not have developed into a critical issue, but may have the potential to do so unless addressed, and/or

e) Where evidence exists that a number of departures from applicable legislative requirements and/or established GCP guidelines have occurred within a single area of responsibility, indicating a systematic quality assurance failure.

Other:

f) Where evidence exists that a departure from applicable legislative requirements and/or established GCP guidelines and/or procedural requirement and/or good clinical practice has occurred, but it is neither Critical nor Major.

Completed MHRA Corrective and Preventative Action Plan

MHRA GCP Inspection Statement

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