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MHRA - Guidance Oversight and monitoring activities

9th February 2022

MHRA Guidance - Oversight and monitoring activities

Oversight and monitoring activities can include a broad range of activities, for example;

  • the use of committees to manage the trial or review the emerging safety data
  • central review of clinical trial data
  • documents and reports
  • feedback from questionnaires sent to investigators
  • data management processes
  • statistical review of the data from the trial
  • pharmacovigilance signal detection
  • regular review meetings (e.g. sponsor with Contract Research Organisation (CRO)/Chief Investigator).

Audits and visits to the investigator site by a trial monitor and auditors to assess the conduct of the trial is considered to be part of oversight.

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