• Scientific merit and interest
• Potential clinical significance
• Study design
• Fit of eligibility criteria with the profile of Consortium patients
• Value added by participation of Consortium investigators
• Fit of the trial within the context of other open trials
• Feasibility
• Anticipated accrual
• Potential for enrollment of women, minorities and individuals across the lifespan

Before SRC review, the Study Team must complete the following steps:

1. Contact Research Group Admins to schedule a Research Group review.
2. Complete the OnCore REDCap Intake Form.
3. Review the SRC meeting schedule and prepare documents for SRC submission.
4. Verify the following Task List tasks are complete in the OnCore record: A20 CRS Intake Review; CRS20 DSMP Review 
5. Initiate an Initial Review submission in the OnCore ePRMS console.
6. Attach the most current versions of the required documents in the OnCore ePRMS console.
7. Complete and submit the Initial Review submission in the OnCore ePRMS console.
   
8. Respond to all queries issued by the PRMS Coordinator.

The PRMS Coordinator must complete the following steps:

1. Review the OnCore ePRMS console and verify minimum SRC submission requirements are met.
2. Send OnCore queries to the study team for any issues or clarifications needing resolution.
3. Verify study team has addressed and responded to all OnCore queries.
4. Place the study on an SRC agenda for review.
5. Issue the SRC Result Letter to the study team detailing the review outcome.

After SRC review, the Study Team must complete the following steps:

1. Review the SRC Result Letter and take necessary action, as needed.
2. For protocols that are disapproved, respond to the SRC with revised, updated, or additional protocol documents.
3. For protocols that are conditionally approved, respond to the SRC with clarifications.
4. For protocols that are approved, proceed with submitting to the IRB of record.

1. Research Group Review Summary available at https://redcap.link/rgr
   • Completing the REDCap form will generate a PDF copy that must be uploaded to OnCore.
   • The completed form must be dated within three months of the submission to the SRC.
   • More information can be found on the Research Group Review page.
2. Current Protocol
   • Protocol templates are available on the Clinical Research Resource Website
3. Investigator Brochure
   • Required for Industry-Sponsored trials
   • Highly recommended for all other submissions to the SRC

Submissions qualifying for an expedited initial SRC review may require additional documents to be attached to the submission.

Multi-site institutional trials require full review by a single NCI-approved Cancer Center PRMS. If a trial received full approval from an external PRMS, the Consortium SRC may complete an expedited review with additional documentation. Submissions without external PRMS documentation will default to full Consortium SRC review.

To submit an expedited SRC review, the following documents are required in addition to the standard required documents.

1. External PRMS Initial Approval Letter
   • This letter must include a clear statement of full PRMS/SRC approval of the new protocol from the external institution. 
2. External PRMS NCI Status Document
   
   • This needs to be a document of the current approval status of PRMS committee of the external institution by the NCI.
   • If the External PRMS Initial Approval Letter includes documentation of the NCI approval of the PRMS, then this document is not separately required.

The Consortium PRMS has been fully approved by NCI and can serve as the PRMS of record for other sites. To provide proof of PRMS review to another site, include the SRC Meeting Result Letter (distributed to the PI after SRC Initial Review) and documentation of our PRMS status, found here.

If an investigator-initiated trial is subject to SRC Review, major modifications to the protocol that impact scientific elements must be submitted for full committee review, regardless of the IRB of record. Modifications requiring review are described in the SRC Modification Form. The following documents are required for SRC modification reviews:

1. SRC Modification Form
2. Summary of Changes document, as needed
3. Updated Protocol (clean)
4. Updated Protocol (with tracked changes)

Final SRC approval documentation shall be submitted with the revision to the IRB of record. If no scientific elements are modified or if the study has an industry or NCTN sponsor, no Scientific Review of the modification is required.

Protocols or modifications that are conditionally approved require a response to the SRC that is approved prior to submitting to the IRB of record. The following documents must be submitted to the SRC:

1. PI response memo
2. Additional requirements, such as protocol revisions or additional documents, will be outlined in the SRC Result Letter as needed

Protocols that are disapproved require a response and revised, updated, or additional protocol documents to be reviewed and approved prior to submitting to the IRB of record. The following documents must be submitted to the SRC:

1. PI response memo
2. Revised and/or Updated Protocol Documents
3. Additional requirements may be outlined in the SRC Result Letter as needed

The SRC monitors active trials for scientific progress, including accrual according to the Consortium Low Accrual Policy. For any trial determined to require a full SRC low accrual review, the study team will be notified via a Low Accrual Notification. Study teams must respond to the SRC low accrual notice by uploading the following documents in the OnCore ePRMS console:

1. SRC Low Accrual PI Response Form
2. Current Protocol
3. SRC Low Accrual Closure Appeal Form, as needed (only one opportunity per trial)

Consult the SRC Low Accrual Job Aid for additional information on low accrual reviews and requirements.