How to Submit to NCI CIRB

All NCI-sponsored clinical trials that fall under the NCI CIRB purview must use the NCI CIRB as the IRB of record.

Generally NCI CIRB reviews the following studies:

-Adult – Late Phase Emphasis – NCI-sponsored adult phase 3 and large phase 2 studies.

-Adult – Early Phase Emphasis – NCI-sponsored adult phase 0, 1, and 2 studies.

-Pediatric – NCI-sponsored pediatric studies of all phases

To confirm whether a study is under NCI CIRB purview visit their website at and search the “Studies List”

-If the study is listed on the NCI CIRB Studies List, the study must go through NCI CIRB.

-If the study is not listed on the NCICIRB Studies List, please submit to COMIRB according to their submission policy.

While NCI CIRB will be the IRB of record for eligible studies, UCD will continue to monitor the conduct of the research.

Opening a New CIRB Study

Confirm the study is eligible for NCI CIRB review by checking the Studies List on the CIRB website.

The PI/study staff will obtain an IRB number by logging into InfoEd at https://era.cu.edu and completing the following steps:

  • Within the menu on the left-hand side select “My Human Subjects”
  • Next select “Create New”
  • Enter the title of the study and click “Continue”
  • Select the PI and click “Continue”. The IRB number has now been generated for your study.

Complete the Personnel – Section C page within InfoEd.

-Study team members must be current on their UCD-required education.

To open a new study with CIRB, go to IRB Manager ( complete the submission per CIRB policy.

UCD Review following NCI CIRB Approval

Upon receiving approval from NCI CIRB, the PI/study staff will email the following study documents to

  • CIRB Approval of Study-Specific Worksheet
  • Approved Protocol
  • CIRB approved Informed Consent Form with Boiler Plate Addendum
  • PRMS Approval Letter
  • CIRB coversheet identifying sites

The External IRB coordinator will conduct do an in-house review ensuring the investigators and staff are current with their required education and verify that no one listed on the study has a conflict of interest with the study. If necessary, the External IRB Coordinator will coordinate with the Conflict of Interest Coordinator to determine next steps.

The External IRB Coordinatorswill also review the institution-required boilerplate language in the CIRB approved consent form to confirm the language is appropriate.

Once the External IRB Coordinatorhas determined the submission is complete they will upload the documents into InfoEd and will send the Notice of Outside IRB approval and the Certificate of HIPAA Compliance to the PI and primary contact via InfoEd, which also serves as the UCD general acknowledgement. The UCH RSS team will be notified of this step which will allow the final EPIC build as required.

For Subsequent Changes

Please note that local personnel, site, and/or boilerplate language changes must also be emailed to CD CIRB Change Form which can be found on the COMIRB website.

  • When adding an additional site (UCH,CTRC), the Clearance/Approval Letter from that site must accompany the Change Form if applicable.
  • If any changes are made to the boilerplate language after initial approval, please submit a highlighted and clean copy of the consent form along with the Change Form.

For Closures

It is the PI’s responsibility to submit a Study Closure in IRB Manager once the site is no longer participating in a trial. CIRB will send the PI and UCD an acknowledgement letter of the closure and UCD will process the closure in InfoEd.

For any further questions regarding the CIRB process, please call the CRSC mainline at 41111 or email the External IRB Coordinators at

Instructions – How to Submit to CIRB

Version Date – 8/27/2014