Advancing today’s discoveries to improve health for all.

Independent Safety Monitor

Independent Safety Monitor

The CTSI can provide assistance with clinical research monitoring on investigator-initiated trials.

Independent Safety Medical Monitor Support we provide:

  • Physician Advisor to the protocol team/sponsor investigator on Safety Oversight for low risk Investigator Initiated Trials
  • Independent real-time safety monitoring through reviewing adverse events (including Serious Adverse Events) and safety reports
  • Independent Adverse Event assessment/attributions
  • Evaluation of individual and cumulative study data to make recommendations regarding the safe continuation of the study.
  • Detailed review of study related documents

An independent safety monitor’s primary responsibility is to provide independent safety monitoring in a timely fashion, by reviewing adverse event and serious adverse event details in real time, from discovery to event resolution. They will make recommendations and act as in an advisory role to the sponsor-investigator for investigator-initiated trials.

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