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Medical Monitoring Procedures



  • Anon
    11/10/2016 04:59
    I'm looking for some guidance on the basic procedures required for medical monitoring processes. Are there any resources out there? Where are the essential processes defined? Thank you.
  • GPvP Committee
    27/10/2016 11:03
    Dear Anon, There is no specific regulatory guidance to define the expectation for medical monitoring but the requirements for sponsor management of Clinical Trials is recorded in the various regulatory environments, for example the European Clinical Trial Directive (EC) No. 2001/20/EC http://ec.europa.eu/health/human-use/clinical-trials/directive/index_en.htm and supporting national legislation. ICH GCP 5.3 ‘Medical Expertise’ requires ‘the sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose’ ICH GCP 5.4.1 ‘The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports’ Those responsible for medical monitoring would be employees of the sponsor (or contracted vendor) who, based on their medical and study-specific knowledge, are able to provide advice on trial related medical questions/problems. They may/can be involved in designing clinical trial protocols to a study protocol design, provide advice on inclusion/exclusion criteria, (serious) adverse event review, medical coding, review of laboratory reports, physician medical review and signal detection, input into aggregate reporting, responding to questions from investigators, study coordinators, and research associates, regulatory personnel, and other staff. The MHRA Grey Guide ‘Good Clinical Practice Guide’ also provides additional information e.g. section on ‘Out of hours medical coverage’. The sponsor company would define the expectations for their medical monitoring, quality standards and tools, depending on the trial. In the UK the Royal College of Pharmaceutical Medicine provides information about Pharmaceutical Medicine careers and training that might give you more details. Please let us know if you have any follow up questions.
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