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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