The ACTRI Scientific Review is a required step for certain investigator-initiated studies at UC San Diego using ACTRI services. This review ensures that studies meet the highest standards of scientific rigor before they begin enrolling participants.
When a Scientific Review Is Required
Scientific Review is required for all investigator-initiated studies that have not already undergone a formal scientific review by a recognized body such as the NIH, FDA, or another federal sponsor.
Examples of when ACTRI Scientific Review is required:
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Studies funded by non-federal grants (e.g., foundation or internal funding).
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Studies where the investigator is acting as the sponsor, and the protocol has not been reviewed by an NIH study section or FDA process.
Studies do NOT require ACTRI Scientific Review if they have already been reviewed by:
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NIH study sections
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FDA-authorized scientific review
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Sponsored studies with formal scientific review already completed
- Industry sponsored studies
Why Scientific Review Is Needed
This process is mandated by the National Center for Advancing Translational Sciences (NCATS) as part of UC San Diego’s Clinical and Translational Science Award (CTSA).
The purpose is to:
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Ensure studies are scientifically sound and ethically justified.
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Help protect participants by confirming the study is designed to achieve its goals with proper statistical and data management plans.
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Strengthen proposals for future external funding by improving clarity and rigor.
What the Review Covers
The ACTRI Scientific Review Committee evaluates the following key areas:
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Translational Impact – Potential clinical relevance versus exploratory work.
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Study Objectives – Clearly stated aims with well-defined endpoints.
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Scientific Merit & Rationale – Justification for the study, including supporting literature and preliminary data.
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Study Design – Methods, randomization, blinding, and strategies to reduce bias and ensure robust data collection.
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Eligibility Criteria – Clear inclusion/exclusion criteria and stratification factors.
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Outcome Definitions – Clearly defined primary and secondary outcomes.
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Statistical Analysis & Sample Size – Appropriate methods and justification to achieve study objectives.
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Data Management – Plans for quality control, data cleaning, analysis, and secure storage.
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Investigator & Site Qualifications – PI’s expertise, available resources, and plans for study registration (e.g., ClinicalTrials.gov).
The Review Process: What to Expect
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Submission:
The study team uploads the protocol and consent documents to the ACTRI Scientific Review system in Monday.com after being notified by the ACTRI team during the normal study onboarding process. -
Reviewer Assignment:
A panel of volunteer investigators is assigned to review the study. Reviewers have 10 business days to provide feedback.-
A specialized team reviews the statistical analysis section.
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Consolidation and Review The consolidated review is sent to the Scientific Review leaders for final evaluation. If no concerns are identified, the study is approved. If there are concerns, they are sent back to the PI for written responses.
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Revisions & Final Approval:
The PI addresses reviewer concerns in writing. The committee review the responses and either approve the study or request further clarification.
Timeline
The full review process generally takes 2–4 weeks, depending on study complexity and the need for revisions.
To avoid delays, ensure that:
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Protocols are complete and detailed at the time of submission.
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Statistical analysis and sample size justification are clear and well-documented.
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Consent documents align with the protocol.