Roles and Responsibilities
For each study overseen, the DSM-EC will perform the following activities:
- Review the research protocol and the investigator's plan for data and safety monitoring which includes:
- Nomination of at least two individuals with protocol-specific expertise
- Details of adverse event reporting, including documentation, reporting, grading, attribution, person(s) responsible for these decisions and criteria used
- Pre-specified stopping rules in relation to adverse events, futility and efficacy
- Primary outcome measures
- Plans and timing for interim analyses, if to be conducted
- Identification of a statistician to provide statistical analyses
- Proposed frequency of protocol monitoring.
- Request that KUMC's Research Institute Clinical Research Administration Division conduct periodic quality indicator visits to assure data collection and recording are compliant with the protocol.
- Identify additional variables to review as part of the monitoring process, if indicated.
- Work with the DSMB and the investigator to develop reporting forms.
- Consider new scientific developments outside the study that may impact participant safety or ethics of the study
- Review all the deliberations of the protocol-specific DSMB and make recommendations to the referring body regarding the status of the protocol: continuation with or without changes, suspension or termination.
The DSMB also has the following responsibilities:
Conduct a formal self-review annually to make any needed changes to DSM-EC operating procedures.
Report DSM-EC activities annually to the Associate Vice Chancellor for Compliance.
Dec 14, 2012