FDAnews Drug Daily Bulletin

MHRA Cites Data Management and Integrity Issues in GCP Inspection Report

May 15, 2018

Problems with inaccessible trial master files are among the nonconforming practices cited in the latest good clinical practice inspection report from the UK Medicines and Healthcare products Regulatory Agency.

From April 2016 to March 2017, the agency inspected 16 commercial and 8 non-commercial organizations, recording 10 critical findings among seven businesses. Of the non-commercial organizations inspected, which comprised 3 universities, 4 NHS trusts and a charity, only one critical finding was logged.

One critical recordkeeping issue involved a firm retaining several essential documents in different electronic systems that were not defined as part of the trial master file (TMF) and were not accessible by inspectors. In addition, the TMF presented did not contain all the essential documents needed to reconstruct trial events and show compliance with regulations and the firm’s quality system.

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