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Pediatric Clinical Research Office
Scientific Review
The purpose of Scientific Review is to ensure the research plan has scientific merit and a reasonable likelihood of successful implementation and outcome.
The depth of the Scientific Review is intended to be at the level of a manuscript review for publication, with special attention to study merit, design and to PI qualifications.
Two categories of review are required of all clinical research studies.
- Scientific Review
The Scientific Review is an assessment of the research plan or science and investigator qualifications. Review the Scientific Review standards.
- Resource Review
The Resource Review is an assessment of the departmental resources necessary for execution of the research plan (divisional budget, personnel, space) and assessment of the environment of care in which clinical patient care will be performed
For guidance with these reviews, please email Nicholas Ferraio, MS, MPA.
Three levels of approval are required for clinical research proposals in the Department of Pediatrics.
1. Division Chief
Approval of research plan, budget, use of divisional resources, and environment of care in which the clinical activities will be performed.
2. PCRO
Approval of resources, budget and documentation of scientific administrative review.
3. Office of the Chair
Approval of the research plan and the project in entirety on basis of PCRO recommendation.
Elements of Scientific Review
- Scientific Review Standards
- Methods of Scientific Review
- Evidence of Scientific Review
- Scientific Review through the PCRO
- Scientific Review Approval Process
- PCRO Clinical Research Proposal Sign-Off From and Request for Scientific Review (Print the paper version.)
PCRO
