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