FDAnews Drug Daily Bulletin

MHRA Flags Data Integrity, Recordkeeping in New GCP Inspection Report

July 26, 2017

Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections.

The agency conducted a total of 102 inspections for the period covering April 2015 through March 2016, logging critical findings among three commercial sponsors and eight non-commercial organizations, such as university clinical trial units and NHS trusts.

Data integrity issues included problems with electronic patient diaries and an audit trail lacking the necessary time stamps. Critical findings related to essential documents included a trial master file with missing records.

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