Clinical Research Program

The Pediatric Clinical Research Coordination Program provides Department of Pediatrics faculty and staff with comprehensive support to conduct clinical research studies at the University of Wisconsin. Study coordinators have extensive experience in all areas of pharmaceutical research, PI-initiated research and registries in all pediatric specialties.

Program Objectives

Our program is designed to handle multiple research studies simultaneously, to meet enrollment goals and to facilitate rapid budget and contract turnaround to promote timely study initiation. Overall objectives include:

  • Coordination of all aspects of research studies, including multi-center trials and investigator-initiated research;
  • Administrative, regulatory, and operational support to investigators to promote study initiation and implementation;
  • Support of outcomes and disease management research;
  • Implementation of translational research projects; and
  • Referral and facilitation of biostatistics support with the Department of Biostatistics and Medical Informatics for clinical research for safety (DSMB) and endpoint analysis.

 

Services

  • Regulatory Support
    • Consultation on all types of IRB submissions
      • Note:  In general, the fee for non-NIH and non-trainee initiated initial review is approximately $3,000. There are several types of projects that are exempt from HS IRB fees. For questions associated with fee exemptions or funding of HS IRB or WIRB fees, please see: https://kb.wisc.edu/hsirbs/17762
    • Maintenance of all sponsor and FDA regulatory documentation
    • Monitoring of clinical research compliance
  • Administrative Support
    • Financial oversight of clinical research accounts and activities
  • Study Coordination
    • Inpatient and outpatient coordination of research studies
    • Recruitment of eligible subjects
    • Comprehensive subject follow-up
    • Timely data entry and query resolution
    • Assistance with REDCap (web-based application used for building and managing data collection forms).
      • In general, the REDCap fee is $200/project/year.
    • Biosample processing, storage, and shipping

 

To request services for funded and unfunded studies, please visit: https://www.pediatrics.wisc.edu/research/clinical-research-program. Each request will be reviewed by Drs. Wald & Gern.