The MU School of Medicine Data & Safety Monitoring Committee (DSMC) serves as a resource for faculty members without access to other multi-site data safety and monitoring boards (DSMBs), especially for investigator-initiated trials. The Health Sciences Institutional Review Board (IRB) also calls on the committee to act as a resource for situations when monitoring may be needed.
Providing Research Oversight & Ensuring Data Integrity
The DSMC helps investigators and MU research compliance oversight mechanisms protect human-research participants and ensure the integrity and scientific validity of research data. To accomplish this mission, the committee:
- Educates investigators, research teams and faculty on data and safety monitoring
- Reviews proposed data and safety monitoring plans
- Establishes data and safety monitoring boards
- Conducts independent interim reviews of study safety and progress
- Makes recommendations regarding the continuation of studies, including whether to modify, suspend or terminate a study
For details, download the DSMC Fact Sheet [PDF] and the Data Safety & Monitoring Plan Checklist [Word].
Members
| Member | Department |
|---|---|
| Arthur Rawlings, MD | Surgery |
| Syed Naqvi, MD | Medicine |
| David Beversdorf, MD | Radiology/Neurology |
| Lea C. Brandt, OTD, OTR/L | Center for Health Ethics |
| Kelli Canada, PhD, MSW | School of Social Work |
| Greg Alexander, PhD, RN, FAAN, FACMI | Sinclair School of Nursing |
| David Fleming, MD | Medicine/Center for Health Ethics |
| Sonja Grinfeld, PharmD | Investigational Drug Service Pharmacist |
| David Mehr, MD | Family and Community Medicine |
| Mojgan Golzy, PhD | Biostatistics Group |
| Greg Petroski, PhD | Biostatistics Group |
| Shivendra Shukla, PhD | Medical Pharmacology/Physiology |
Ex Officio Members
| Member | Department |
|---|---|
| William Fay, MD | School of Medicine Office of Research |
| Jennifer May, JD | Chief Compliance Officer, MU Health Care |
| Don Reynolds, JD (Executive Secretary) | Office for Responsible Research |
Investigator Tools
Data and safety monitoring tools available for investigators include:
- Adverse Event Summary [Excel]
- Data & Safety Monitoring Plan Template [Word]
- Patient Enrollment Summary for Device Studies [Excel]
- Patient Enrollment Summary for Drug Studies [Excel]
Committee Tools
For the work of the committee, DSMC members may use the following tools:
- Analysis of Adverse Event Data [Word]
- Baseline Demographics & Relevant Clinical Characteristics [Excel]
- Initial Review Packet [Word]
- Letter of Agreement [Word]
- List of Data Tables for Routine Surveillance [Word]
- Reviewer Worksheet [Word]
