WFUHS INSTITUTIONAL DATA & SAFETY MONITORING BOARD
The WFUHS Institutional Data & Safety Monitoring Board (I-DSMB) is a Dean-appointed, multi-disciplinary, standing committee that is available to provide independent oversight for human research studies conducted by WFUHS or by WFUHS-affiliated faculty investigators. The I-DSMB can provide (at no cost) oversight for appropriate WFUHS investigator-initiated, locally conducted (single- or multi-site) clinical trials receiving NIH, departmental, or other non-industry support. The I-DSMB may also serve as the primary independent monitoring body for some trials sponsored by industry (a fee for monitoring services would be involved; see link below for further information). Clinical studies originating at institutional affiliates of WFUHS (WFU Reynolda campus, TSI affiliates) could also utilize the WFUHS I-DSMB for their qualifying research studies.
An independent Data and Safety Monitoring Board (DSMB) may be needed for high-risk human research studies, for studies in which the investigator and/or the institution may have a potential conflict of interest, for studies involving vulnerable populations or for multi-site studies. DSMB members review on a regular basis study information pertaining especially to human subject safety and study integrity.
For questions about the I-DSMB or about other study monitoring issues, please contact Ms. Susan Margitić, I-DSMB Director, (smargiti@wfubmc.edu, phone: 336-716-5647). We especially encourage you to consider your clinical research study monitoring needs during the grant or IRB pre-submission phase of your study.
Other Useful Links
Establishment and Operation of Clinical Trial Data Monitoring Committees:
http://www.fda.gov/cber/gdlns/clindatmon.htm#2
NIH Policy for Data and Safety Monitoring:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
Further Guidance on Data and Safety Monitoring for Phase I and Phase II:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html