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.

Resources

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)

REGIST-100: Eligibility Checklists (DF/HCC Policy) REGIST-OP-3: Eligibility Checklist Development (DF/HCC Operation)

A protocol-specific eligibility checklist is required for any protocol with eligibility criteria where subjects are registered in OnCore. Protocols that are designed to enroll only a single subject are exempt from this requirement.
Study teams should always use the current eligibility checklist available on OncPro. For more information on OncPro access, please see the OHRS Systems Access page.
Briefly, ODQ will create the eligibility checklist for each protocol by extracting the eligibility criteria pages from the protocol document itself and attaching a "coversheet". If the protocol document does not contain checkboxes, ODQ will add them to facilitate completion of the checklist.
Please note that ODQ is only able to extract full pages from the protocol document as approved by the IRB. This means that the checklist may include some language from other protocol sections that occur on the same page as the start/end of the eligibility criteria. Pages cannot be re-numbered.
The Eligibility Checklist will have a standard cover sheet followed by the pages from the IRB-approved protocol document that contain the eligibility criteria. No changes will be made to the pages extracted from the IRB-approved protocol, except for the addition of checkboxes if they are not already present.
Click here to see an example.
Screening Staff may choose to make notations in blank spaces or margins. If the eligibility checklist is being used as source documentation, the Screening Staff must comply with applicable DF/HCC policy (DOC-100) when completing the eligibility checklist.
All checklists undergo quality control review before they are posted to OncPro. Please contact us at ODQ@dfci.harvard.edu if corrections are needed.

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
Events
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.