Roles and Responsibilities

For each study overseen, the DSM-EC will perform the following activities:

1. 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.

1. 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.
2. Identify additional variables to review as part of the monitoring process, if indicated.
3. Work with the DSMB and the investigator to develop reporting forms.
4. Consider new scientific developments outside the study that may impact participant safety or ethics of the study
5. 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.