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CRB Forms and Submission Information

All study protocols involving animals must first be submitted to the IACUC for determination of the appropriate review process.

To begin the process, study personnel need to create and submit an IACUC waiver or protocol using Kuali Protocols (KP), CSU’s electronic protocol management system.

Questions about KP, the appropriate IACUC form to complete, or any other questions about the review process can be directed to the CRB Personnel or the IACUC Coordinators.

Please note: Depending on the study, additional approvals may be necessary before a study can be initiated. A veterinary clinical study using privately-owned animals may not be initiated until final approval by all the appropriate oversight committees is granted.

Help Documents for Kuali Protocols:

The CRB has developed consent form templates that can be used and uploaded into KP for review:

Please see the Best Practices page for additional information about consenting and clinical trials conduct.

Amendments:

  • If there are any changes to an approved CRB or IACUC protocol using privately-owned animals, an amendment needs to be submitted through KP.  For detailed information on how to submit an amendment, please see the How to Amend VTH CRB Form help document. Once the IACUC has completed their review, then the CRB will review the proposed changes.  Amendments must be approved prior to initiation of the proposed changes.

Continuing Review (e.g. annual renewal, annual protocol update):

Continuing Review is required for studies using privately-owned animals and must be submitted by the investigator in KP.  For detailed information on how to submit a continuing review, please see the How to Renew VTH CRB help document.

Continuing Review is required annually, and email reminders will be sent to protocol personnel.

If a Continuing Review has not been submitted after three reminders, the protocol will be closed and no further work can occur on the protocol.

Adverse Events:

Monitoring of adverse events (AEs) is critical to the safety of study animals and data integrity.
The CRB expects that investigators will assess, document, and review all AEs that occur during the course of a clinical trial at regular intervals.

If serious AEs occur, whether expected or unexpected, these events should be reported to the CRB promptly through KP and/or by email.

Unexpected AEs may require submission of a protocol amendment to ensure that the informed consent document and clinical study protocol are accurate.

Please find additional AE resources, including definitions of an AE, on the Adverse Events page.

Protocol Closure:

Once a study is completed, the protocol should be closed out in KP. Study personnel can use the “Request Close” function to complete the study closure process.