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Pediatric Clinical Research Office
Scientific Review Standards
The Scientific Review Standards in the Department of Pediatrics are designed to ensure that the clinical research proposal:
- Is evaluated for the appropriateness of the research
- Protects the overall safety of research subjects
- Assesses the appropriateness of the environment of care in which the clinical activities will occur
The Scientific Review includes the following components:
- Sufficient background and justification
- Reasonable hypothesis
- Study design
- Statistical plan
- Likelihood of answering the hypothesis
- Environment of care assessment
- Resources
- Feasibility of successful study completion
- Investigator qualifications
- Major safety concerns
- Major data monitoring concerns
- Major conflict-of interest concerns
A favorable review confirms that the study has sufficient scientific merit to proceed and that the investigator team is qualified to perform the research.
PCRO