Step 1
Protocol Administrative Review
Step 1: Protocol administrative Review. To start this process, start your OPERA REQUEST/SUBMISSION. OPS coordinator will review protocol submission for accuracy and completeness.
Step 2
Feasibility Review Assessment
Step 2: Feasibility Review. A Population Sciences Reviewer will assess and determine study feasibility and priority.
Step 3
Site Disease Group (SDG) Endorsement
Step 3: Obtain approval from the appropriate Site Disease Group (SDG). The SDG Population Sciences Leader will review the study protocol in consultation with the SDG. The OPS will facilitate the reviews in Steps 2 and 3 in parallel, to avoid delays. Alternatively, the study team may obtain SDG endorsement prior to OPERA submission.
Step 4
Protocol Review and Monitoring Committee (PRMC) approval
Step 4: Obtain Protocol Review and Monitoring Committee (PRMC) approval. After SDG endorsement (if applicable), the committee will provide review and approve study scientific merit.
NOTE: Consistent with UM Policies, PRMC review and approval are required for all cancer-relevant research PRIOR TO IRB APPROVAL.
NOTE: Consistent with UM Policies, PRMC review and approval are required for all cancer-relevant research PRIOR TO IRB APPROVAL.
Step 5
UM IRB Submission and Approval
Step 5: UM IRB submission. The submission process uses the University of Miami's Electronic Protocol Submission and Tracking system (IBISResearch). More information about registration with IRB10 System and required trainings can be found on the UM IRB webpage “Information for Researchers | Human Subject Research Office | University of Miami” Our team can assist Cancer Center members with IRB submission.
Step 6
Study Activation
Step 6: Study Activation. Once approved by the IRB and your study is ready for activation, please contact the OPS Data Team so we can record your study as “Open to Accrual”. We can facilitate activating the study in Velos (eResearch Clinical Trials Management System).
*All investigators conducting cancer-relevant research at UM are responsible for providing SCCC with status updates and select data related to subject accruals, consistent with NCI accreditation requirements, using data collection system (e.g., REDcap).