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Pediatrics / Research / Pediatric Clinical Research Office / Scientific Review Standards
 

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.