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Institutional Data Safety & Monitoring Board

The Institutional Data and Safety Monitoring Board (I-DSMB) is a standing committee available to provide independent oversight for human research studies conducted by WFBH of WFBH-affiliated faculty.

Details

  • An independent Data and Safety Monitoring Board 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. I-DSMB members review on a regular basis study information pertaining especially to human subject safety and study integrity.
  • The I-DSMB can provide oversight for appropriate WFBH 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).
  • I-DSMB members will have expertise in clinical trial methodology and conduct, epidemiology, biostatistics, ethics, and clinical research. Ad hoc members may be invited to serve on the I-DSMB based on a need for unique expertise represented by regular members.

Contact Information

Issis Kelly Pumarol: ikellypu@wakehealth.edu | 336-716-8372

We especially encourage you to consider your clinical research study monitoring needs during the grant or IRB pre-submission phase of your study.

Membership

Effective 7/1/2018

  • Capri Foy, PhD, Co-Chair
  • Haiying Chen, PhD, Co-Chair
  • Nancy King, JD
  • Chadwick Miller, MD
  • Thomas Wesley Templeton, MD
  • Wei Lang, PhD
  • Xiaoyan Iris Leng, MD, PhD
  • Claudia Campos, MD
  • Mustafa Saad Siddiqui, MD
  • Kate Hayden, PhD
  • Youngkyoo Jung, PhD
  • Clancy Clark, MD
  • Heidi Munger Clary, MD, MPH
  • Arjun B. "Raja" Chatterjee, MD, MS, FACP, FCCP, FAASM
  • Wendy Moore, MD

Ad hoc members:

  • Dr. Preston Miller
  • Dr. Marina Nunez
  • Dr. Jeffrey Rogers
  • Dr. Brian Strittmatter
  • Dr. Robert Evans


Ex officio (without vote) members:

  • Joseph Andrews, Director, PhD, MA, CIP Regulatory Affairs and Research Integrity Office
  • Richard Weinberg, MD, Gastroenterology, IRB Executive Chair 
  • Brian Moore, MS, Director of IRB and Human Research Protection Program
  • Issis Kelly Pumarol, MD, Research Subject Advocate



New to Research?


Review Getting Started with Clinical Research for tips and guidance on conducting clinical research at Wake Forest.

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Be Involved is an opportunity for volunteers to learn more about clinical studies conducted at Wake Forest Baptist Medical Center. Be involved in changing the future of health care. Register today.