Tempus Review Process
Clear, transparent, and efficient review process for your research studies.
Tempus IRB's clear and transparent review process ensures your research moves forward quickly, objectively, and without surprises. Here's how our three-stage review system works:
Stage 1: Submission Completeness Review
Our IRB team first evaluates your submission to ensure it contains all required documentation and information necessary to make a regulatory decision. During this initial stage:
- Efficient Feedback Cycles: If your submission is incomplete, our reviewers clearly communicate the exact information needed. You'll receive actionable feedback items, categorized as either mandatory or optional.
- Proactive Classification Insights: We'll inform you upfront about the likely regulatory classification (Exempt, Expedited, or Full Board Review). Additionally, we proactively suggest adjustments that could lower your review classification—saving you time and effort.
- Streamlined Revisions: Your submission moves seamlessly into "Edits Required" status if further information or adjustments are necessary, ensuring clarity and efficiency in revisions.
If your initial submission already includes all necessary information, your study proceeds swiftly, bypassing additional review cycles.
Stage 2: PI Approval of Complete Submission
Once your submission is deemed complete, the Principal Investigator (PI) performs a critical validation step:
- Efficient PI Approval: The PI reviews and provides formal e-signature approval, attesting their commitment to ensure the study, when operationalized, will meets all applicable ethical standards and regulatory guidelines (FDA, OHRP, etc.).
- Certainty and Accountability: This step assures accountability and clarity, confirming that the IRB has exactly what's needed for a definitive regulatory review.
Stage 3: Final IRB Review & Decision
With a complete and PI-approved submission, Tempus IRB conducts a final review to reach a swift and objective decision:
- Transparent Decision-Making: At this stage, if all feedback has been addressed appropriately, your submission will be either approved outright or conditionally approved with minor modifications.
- Immediate Documentation: Upon approval, you'll instantly receive a downloadable decision letter clearly outlining any minor edits required, ensuring you can move forward confidently.