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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