1. Study team completes required documents for submission.

• Study team should refer to the submission deadlines when planning for submission to the SRC.
• Study team should confirm that they are using the most current versions of the forms and document templates by downloading from websites each time.
• Study team will need to complete all required documents in their entirety and assure the PI has reviewed everything before signing.
• Study team submits all documents & required signature pages with submission.

2. Study team completes submission in OnCore.

3. SRC Committee Coordinator reviews documents and issues queries.

• Any issues that must be resolved to meet minimum SRC submission standards will be sent to the study team via queries in OnCore before placing the study on an agenda.

4. SRC Committee Coordinator places submission on agenda after queries resolved.

5. The SRC issues a result letter.

• Studies that are approved as written can move forward to IRB submission. Studies that are conditionally approved or disapproved require a response to SRC that is approved prior to submitting to the IRB of record.

• Research Group Review Summary for SRC Form available at: https://redcap.link/rgr
• Protocol using protocol templates available on the Clinical Research Resource Website

If an investigator-initiated study is subject to Scientific Review, regardless of the IRB of record, major modifications to the protocol need to be reviewed by the SRC that originally reviewed and approved the study. If scientific elements are modified, as described in the SRC Modification Form, the revision must be submitted for full SRC review.

In addition to the SRC Modification Form, a clean protocol and protocol with tracked changes is required for SRC submission.

Final SRC approval documentation can then 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 SRC review of the modification is required.

The SRC monitors ongoing studies for scientific progress, including accrual rates according to the Consortium Low Accrual Policy. For additional information on low accrual reviews and requirements, consult the SRC Low Accrual Job Aid.

For multi-site institutional trials, a single full review at an NCI-designated Cancer Center with an NCI-approved PRMS (Scientific Review Committee) is required. If the trial received full approval, the other sites are responsible only for an expedited review. 

To submit an approved multi-site institutional trial to our Consortium SRC, you must include the External PRMS Initial Approval Letter in addition to the protocol and Research Group Review form. This letter must include a clear statement of full PRMS/SRC approval of the new protocol and the status of PRMS committee (NCI-approved PRMS.) If the External PRMS Initial Approval Letter does not include the NCI approval of the PRMS committee, please submit this documentation as an External PRMS NCI Status Document to the SRC. External PRMS documentation is required to qualify for expedited SRC review. Submissions without External PRMS documentation will default to full committee review.

The Cancer 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.