VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

event raises new questions about risks to participants or the research design. This report is reviewed by one or more experienced IRB members (typically including the chair) and a decision made as to whether or not the report should be presented and discussed at a convened meeting. If an adverse event that is both serious and unanticipated occurs at a site for which the VCOM IRB has direct oversight responsibility, the PI must notify the IRB within 24 hours (or by the next working day). In case of an adverse event that is serious but not unanticipated, the PI must notify the IRB within 5 working days. In case of an adverse event that is not serious, but is unanticipated, the PI must notify the IRB within 10 working days. And if an UP involving risks to subjects or others (but not meeting the definition of an adverse event) occurs, the PI must notify the IRB within 10 working days. 12.1. Adverse Event Written Report An Adverse Event Reporting Form (Form E) can be found in the forms and templates library of IRBNet and on the VCOM IRB webpage and should be used for reporting and adverse event. The adverse event written report submitted to the IRB must contain the following information: • IRB study number; • Title of protocol; • Name of Principal Investigator and relevant department, division or center; • Subject identifier (study number/reference of subject); • Date and site of event; • Description of event (nature of injury or other adverse occurrence, assessment of severity, and assessment of relationship to study); • Handling/response to the event; • Any proposed changes in protocol or consent form due to event; and • To whom else the event has been reported. 12.2. Data and Safety Monitoring Plans The research sponsor and/or the VCOM IRB may require a research study to include a plan to ensure that relevant data are collected and assessed to monitor subject safety within the study. This plan is known as the data and safety monitoring plan (DSMP). Part of the DSMP may be the establishment of a data and safety monitoring board (DSMB), also sometimes called a “data monitoring committee,” to perform the evaluation procedures detailed in the DSMP. The group charged with implementing the DSMP, whether it is the research team or a DSMB, must have adequate expertise to perform the analysis. DSMBs for multi-site studies are responsible for forwarding summary reports of adverse events to each IRB involved in the study. 12.3. IRB Responsibilities The chair or a designated subcommittee of the IRB will review the SAE/UP and will decide whether the report should be presented and discussed at a convened meeting. If an adverse event occurring at the College is related to the study intervention and is both serious and unanticipated, the IRB will notify the Provost and the appropriate campus Dean and the event will be reviewed by the IRB at a convened meeting.

VCOM Institutional Review Board Policies and Procedures

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