Pediatric Clinical Research Office

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