How to Submit to CIRB

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

Generally 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 CIRB purview visit their website at and search the “Studies List”

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

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

While 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 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 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.

-Please remember all study team members must be current on their UCD-required education.

At this time no further action needs to be taken with UCD Regulatory Compliance until afterCIRB approval has been received.

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

UCD Review following CIRB Approval

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

  • Post CIRB Approval / Submission to UCD Cover Letter
  • CIRB Approval of Study-Specific Worksheet
  • Protocol
  • CIRB approved Informed Consent Form with Boiler Plate Addendum
  • PRMS Approval Letter
  • UCH/UCD Clearance Letter
  • SARC Approval Letter (if applicable)

UCD will do an in-house review ensuring the investigators and staff are current with their required education and verify whether any individuals listed on the study have a conflict of interest with the study. If any personnel have a conflict, UCD will coordinate with the Conflict of Interest Department in getting an appropriate Conflict of Interest Management Plan into place.

UCD will also review the institution-required boilerplate language in the CIRB approved consent form to confirm the language is appropriate.

The PI/study staff will be notified by UCD of any missing documents or if any additional information is required.

Once UCD has determined the submission is appropriate they will upload the documents into InfoEd and will send the Certificate of HIPAA Compliance to the PI and primary contact via InfoEd, which also serves as the UCD general acknowledgement. The study is then approved to begin recruitment once it has been built in EPIC at the appropriate institution.

For Subsequent Changes

Please note that local personnel, site, and/or boilerplate language changes must also be emailed to on the UCD 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 Tammy Koeppen at 303-724-1011.

Instructions – How to Submit to CIRB

Version Date – 8/27/2014