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Pediatrics / Research / Pediatric Clinical Research Office
 

Pediatric Clinical Research Office

The mission of the PCRO is to facilitate clinical research of the highest quality to ensure the safety of children. To fulfill this mission, PCRO interacts regularly with investigators, research coordinators, and other departmental staff providing guidance in the preparation and execution of clinical research.

Services

Assistance provided by the PCRO to its investigative and study staff covers a broad range of services adopted to the unique needs of each investigator. These include:

  • Resource Review
  • Scientific Review (if needed) of studies
  • Clinical Research Quality Assurance Reviews (GCP) and Research Clinical Bill Reviews
  • Protocol/project development
  • Budget development and budget negotiations with sponsors
  • Technical review and technical writing
  • Institutional Review Board (IRB) assistance and monitoring studies for compliance with IRB requirements
  • Biostatistical consultation and services
  • Study coordinator services
  • Departmental communications regarding clinical research, compliance, institutional policies, and institution-wide clinical research services
  • Education (Research Quality Improvement Educational Session every other month.  Pediatric Clinical Research working group seminars)
  • Assistance in developing corrective action plans for IRB compliance
  • Liaison with sponsors
  • Review and approval of IRB submission by Pediatric Investigators

Resources