Strong Children's Research Center
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
PCRO


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