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MCC: Improving Inspection Readiness -Trial Master File Basic Metrics

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© Metrics Champion Consortium 2018 3 Improving Inspection Readiness – TMF Basic Metrics Background The Metrics Champion Consortium's (MCC) Trial Master File (TMF) Metrics Work Group was formed in late 2015 at the request of industry and consortium members. Sponsors were experiencing growing pressure from regulators to update their TMF filing and oversight approaches to align with regulatory expectations. In 2014, the UK's MHRA modified their definition of a Critical Finding to include TMF deficiencies. 1 Other regulators also emphasized the importance (e.g. EMA) via the Reflection paper on GCP compliance in relation to TMFs, which is currently revised into a draft Guideline. 2 This draft Guideline includes the following with reference to the EU Clinical Trial Regulation: And where a third party is contracted (e.g. a CRO) there should be clear arrangements including: These regulatory pressures raised significantly the risk of poor TMF management. Following the 2014 MHRA update, sponsors have been cited for TMF deficiencies. The latest MHRA GCP Inspections Metric Report (issued April 2016) listed two critical findings in the commercial sponsor group – both were: Failure of the organisation's Trial Master File (TMF) to be the basis for inspection, readily available, directly accessible and complete as per the requirements of Statutory Instrument 2004/1031 Regulation 31A. 3 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 1 "… arrangements for oversight of the quality control/quality assurance of the TMF by the sponsor and how this would be documented (e.g. audit reports, QC reports); 2 "…the clinical trial master file shall at all times contain the essential documents relating to that clinical trial." The requirement 'at all times' means that the TMF should be updated, and completed in a timely manner. 2

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