Feasibility and Activation
The ODQ performs operational feasibility reviews in iRIS and coordinates final activation of new protocols, amendments and other submissions. The ODQ is responsible for maintaining and posting the current approved study documents to OncPro.
DF/HCC Policies and Operations
ODQ performs a feasibility review of new protocols and amendments prior to IRB review.
During Feasibility, the ODQ will review the following:
- Submission completeness and accuracy
- Inclusion of appropriate documents for OncPro posting
- Subject registration requirements
- Clinicaltrials.gov registration requirements
- Data management services (investigator-sponsored protocols)
- DSMB/DSMC review requirement (investigator-sponsored protocols)
- Investigator training credentials
The ODQ is responsible for the activation of new protocols and amendments following SRC/IRB approval once any requires operational sign offs are complete.
Study teams will need to complete an Operational Readiness some new protocols and amendments, as indicated in iRIS. Once the study team 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 protocol, site and arm/cohort status in OnCore
- Verify DF/HCC training requirements (HSP, GCP, New Investigator Training)
- Post IRB-approved documents to OncPro
- Create and post the eligibility checklist (when required)
ODQ offers navigation assistance for amendments that need to be submitted while another iRIS submission is pending. In the absence of navigator assistance and approval, iRIS users must adhere to business rules that restrict the submission of multiple amendments or the submission of amendments while a new protocol application remains in process.
Requests for exceptions to the business rules should be submitted to DFHCCiRISNavigator@dfci.harvard.edu for evaluation. In cases where an exception cannot be granted, the Navigators can take additional steps to help facilitate submission of time sensitive amendments for phase I and phase I/II protocols.
As a reminder, amendments can be submitted in parallel with any of the following; no approval or navigation support is required!
- Continuing Review/Progress Report
- Administrative Modification
- Dose/Cohort Open/Closure Form
- Sponsor-Investigator Add/Open/Complete External Site
If there is an initial submission or prior amendment in iRIS, please evaluate whether the new amendment can wait for the prior submission to be activated.