General Guidance for NCI CIRB studies

While NCI CIRB will serve as the IRB of Record for NCI CIRB studies, Emory IRB remains responsible for local institutional requirements. Hence, study teams will need to apply to both CIRB and eIRB for approval. We recommend that you start the Emory IRB submission process prior to submitting to CIRB (in order to facilitate ancillary committee reviews).

Steps to Register with NCI CIRB

Step 1: Obtain access to NCI CIRB Participants Area

Complete the webform at obtain an account to NCI CIRB’s IRBManager. This information will be submitted to NCI CIRB by the Emory IRB. Once NCI CIRB processes the request, a separate email with login information will be sent to the new personnel’s email address.

Step 2: Registering a PI for access to NCI CIRB studies

Complete the “Annual Principal Investigator Worksheet About Local Context” form via IRBManager. While the form can be filled out by coordinators, the PI will need to submit the final form.

Steps to Obtain Initial Approval

Step 1: Identify an eligible study

Studies and related materials approved by NCI CIRB are made available to participants on the NCI CIRB website.

Step 2A: Beginning the local review process (We recommend submitting your abbreviated eIRB application prior to submitting to CIRB)

Study teams should contact the IRB listserv at to request access to the abbreviated eIRBSmartform template. Please include the PI name, study title, coordinator and if the study involves pediatric patients.

Once you receive access to the template, you will only be required to complete certain designated sections that pertain to CIRB studies. Once specific sections are complete, please submit as per usual to trigger any necessary ancillary approvals.

Step 2B: Beginning the NCI CIRB approval process

Studies are opened by a Signatory Institution Principal Investigator by submitting the Study-Specific Worksheet to the CIRB for review via IRBManager.

Note, the Study-Specific Worksheet must include any deviations from Emory/NCI CIRB’s Boilerplate Language (i.e. Radiation Safety Language).

Step 3: Processing the NCI CIRB approval

NCI CIRB will email the PI an approval letter, along with the Emory/NCI CIRB’s Boilerplate Language. The study team is responsible for merging the CIRB-approved model consent with the Emory/NCI CIRB’s Boilerplate Language.

Study team should submit the merged consent form, the NCI CIRB approval letter, and the NCI CIRB expiration date for the study via eIRB.

Step 4: Processing Emory’s local acknowledgment

Emory IRB will verify:

  • all study personnel have the required training (Citi and Key Concepts/Intro to Clinical Research)
  • all ancillary reviews have been completed (CTRC, IDS, etc.)
  • the language in the consent matches the required ancillary reviews (Cost, In-Case of Injury, Radiation Safety, etc.)
  • the study meets the criteria for a partial HIPAA waiver

Once the requirements have been verified, Emory will issue an acknowledgment letter.

Stamped ICF/ HIPAA documents can be released only when you have obtained approval from CIRB and Office of Quality Checklist (if applicable).

Steps to Obtain Continuing Review

Step 1: Submit renewal documents to the appropriate cooperative group

Step 2: Provide Emory IRB the continuing review approval letter so expiration dates can be updated in eIRB

Upload the approval letter as a comment to the study. No formal CR is required.

Processing Modifications

NCI CIRB will notify the study team of any modifications to the overall study.

Modifications that require approval from NCI CIRB/ Emory IRB

  • Changes to PI
  • Changes to locally produced advertisements/ requirements
  • Any translated documents not already approved by NCI CIRB

Modifications that require notice to Emory IRB via an amendment in eIRB:

  • Changes to any study personnel
  • Changes to the consent forms

Modifications that do not require notice to Emory IRB via an amendment in eIRB:

  • Changes to the overall study that do not include a consent revision

Processing Reportable Events

In the event of a local unanticipated problem involving risks to subjects or others, or serious or continuing noncompliance, the PI is responsible for reporting to NCI CIRB, according to the NCI CIRB reporting requirements.

Processing Close-Outs

Step 1: PI submits a Study Closure to NCI CIRB via IRBManager

Step 2: PI submits a Close-Out in eIRB once NCI CIRB approves the study closure

Emory Contact

For questions, please contact the Emory External Relations Team:

  • Olga Dashevskaya 404-727-3508 or

Version date 10/06/2015