Jump to content
  • We are now offering Remote Courses

    Equal benefits to our residential courses, without the travel.

    View Courses
  • eLearning Passport

    All our courses. 12 months access. One flat fee.

    More Information
  • Newsletter

    Non-members can signup to keep up to date with RQA news and events.

    Add your details now

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.

Read Article Now

Back to Recent News

Share

Virtual Event Platform