Quality Assurance

The CTSI offers regulatory support and assistance navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications. Registrations and support services are provided by our IND/IDE Navigator, Janet Shuping, CCRC. 

Available services include:

• Providing a centralized resource of information and support related to addressing regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies under investigator-sponsored INDs and IDEs
• Assisting WFUSM researchers in the preparation or review of initial IND or IDE applications, annual progress reports and preparing responses to the FDA

Request a Consultation 

To request a IND/IDE consultation, please use the CTSI Service Request Form. For questions, contact Janet Shuping at Janet.Shuping@AdvocateHealth.org or 336-716-2612.

Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)

The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from North Carolina Institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel Hill, Duke University, Wake Forest University School of Medicine and RTI International.

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). 

Our team is available to assist with new record registration, results submission, opening/editing user accounts, solving record problems, and training. For questions, please Janet Shuping at Janet.Shuping@AdvocateHealth.org.

Learn more by visiting ClinicalTrials.gov Protocol Registration and Results System (PRS).

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 or 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 specific 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 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.
  
  

For questions or to submit a report please contact Janet Shuping at Janet.Shuping@AdvocateHealth.org.