When your Protocol has been Approved for CIRB Oversight

Once the CIRB is designated as the IRB of record for your study, your interaction with CORIHS will be minimal, but very important.

  • Consent Form Revisions: The CIRB will notify the PI and coordinator (by e-mail) when changes to the consent have been made and posted on the CIRB website. Make all changes on the local consent, update the header to match the CIRB approved consent and submit one copy to CORIHS for our records. No approval letter will be issued by CORIHS.
  • Continuing Reviews: Continuing review will be conducted by the CIRB. The PI and the coordinator will receive e-mail notification of these reviews from CIRB.
    • In addition to submission to NCI CIRB, submit a new package to the study in IRBNet with:
      • one copy of CIRB’s continuing review for the study,
      • the updated local consent form,
      • SBU’s Continuing Review Application for NCI CIRB Studies. No approval letter will be issued by CORIHS.
      • Registration form, including all current information
      • a redacted (subject name/initials/ID# blacked out) copy of the consent form of the latest subject enrolled in the study. If it is a study involving children, upload the parent permission and the minor assent forms, as applicable.
      • a redacted, completed checklist for the latest subject enrolled during the prior approval period. 
Random audits of the I/E backup (‘source’) documentation will be conducted by ORC to assess compliance with subject eligibility. Current training and signatures of all study personnel will be required in order for the continuing review submission to be acknowledged by SBU.
  • Unanticipated Problems (including Serious Adverse Events (SAEs): You must submit all Unanticipated Problems occurring in subjects enrolled through SBU (“local UP’s”) to CORIHS, in accordance with CORIHS policy.

From www.ncicirb.org:
“Your local IRB is still responsible for reviewing SAE's that occur at your site; for all others, the CIRB does the review. Investigators continue using their routine reporting procedures. There is no need for the investigator to report SAE's to the CIRB. SAE's are reported using the customary mechanisms on CTEP-sponsored phase III protocols (Cooperative Group and others); the CIRB will be able to access SAE reports directly from NCI, to review SAEs and to report back to participating local IRBs via a confidential web site.”

  •  Local Alterations (e.g., Personnel, Advertisements etc.) Submit any local personnel changes, local advertisements etc. to CORIHS for review and approval. Notification from CORIHS regarding review outcome (approval, modifications required etc.) will be sent to you.
  • Study Closure: To close a CIRB study at this site, submit a “Termination Request Form” to the CORIHS, who will, in turn, notify the CIRB.
  • Protocol Amendments (NOT TO BE SENT TO CORIHS): Whenever the Cooperative Group makes protocol amendments; you must use only the CIRB approved version. These can be downloaded from the CIRB website through the investigator login access.
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