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.
FAQs
-
Independent Safety Monitors (ISM) are appropriate for small, early phase studies that are low risk or of short duration. A DSMB may recommend the designation of one or more ISMs. An ISM may solely focus on serious adverse events when a DSMB is providing additional study oversight.
-
Independent Safety Monitors (ISMs) must be free of any conflict and should not have any direct involvement in the study. ISMs may perform their roles as a member of a data safety monitoring board (DSMB).
-
The Independent Medical Monitor provides adverse event attributions to the study sponsor. They may evaluate safety based on study groupings and in some cases, they may also help to answer study related questions from study sites. The study team is responsible for identifying an Independent Medical Monitor. The CTSI can help provide a guidance document to the Independent Medical Monitor, but they do not provide that service. For Medical Monitor guidance please contact Amy.Bartlett@osumc.edu.