Feasibility and Activation
The ODQ will take on an expanded role in Feasibility and Activation with the implementation of the new Protocol Review and Monitoring System (PRMS). In preparation, the responsibility for this work will shift from OHRS to ODQ starting February 4, 2019.
This page will be updated with new information and documents as needed throughout this transition period.
FAQs about this Transition
In the new PRMS system (iRIS), the ODQ will perform a Feasibility review of new protocols in parallel with feasibility reviews performed by institutional Nursing and Pharmacy departments. Feasibility will occur shortly after the initial submission and prior to IRB review.
During Feasibility, the ODQ will review the following:
- Subject registration requirements
- Clinicaltrials.gov registration requirements
- Data management services (investigator-sponsored protocols)
- DSMB/DSMC review requirement (investigator-sponsored protocols)
- Investigator training credentials
In the new PRMS system (iRIS), the ODQ will be responsible for the activation of new protocols and amendments following SRC/IRB approval.
Study teams will need to complete an Operational Readiness step in the system. Once the study teams confirms they have all operational pieces in place to activate, ODQ will perform the following tasks:
- Verify study team operational readiness and required approvals
- Verify and update required information in OnCore (accrual numbers, NCT #, open/close arms)
- Verify any DF/HCC required training that was requested during Feasibility review (HSP, GCP, New Investigator Training)
- Post IRB-approved documents to OncPro
- Create and post the eligibility checklist (when required)