CRB Forms and Submission Information
All study protocols involving animals must first be submitted to the IACUC for determination of the appropriate review process.
- For studies involving privately-owned animals, the review process is performed in Kuali Protocols (KP). After logging in with your CSU EID/password, choose the “IACUC Waiver” option.
- The “Consent Form Information” option should be chosen in addition to “IACUC Waiver” when the work is being done by or at the request of the CSU Veterinary Teaching Hospital (VTH) faculty/staff/students or the work is occurring at the VTH.
- Once the IACUC has reviewed the Waiver and determined that an IACUC Protocol is not required, CRB Review of the protocol will begin.
- If the study involves privately-owned animals and requires an IACUC Protocol, then the CRB will review the consent form once the IACUC has approved the protocol.
Please note: Depending on the study, additional approvals may also be necessary before a study can be initiated. A veterinary clinical study using privately-owned animals may not be initiated until final approval by the appropriate oversight committee is granted, e.g. IACUC or CRB.
CRB Review for an IACUC Waiver:
- In the “Consent Form Information” section choose “yes” when the CRB must review the information provided, e.g. when the work involves privately-owned animals and is being done by or at the request of CSU VTH faculty/staff/students or the work is occurring at the VTH. After choosing “yes,” the “CRB Submissions” questions and a text box to answer them will appear.
- Below the “CRB Submissions” text box the Consent Form and other relevant project materials/documents (e.g. original study protocol, client information sheet, study timeline, etc.) can be uploaded.
- 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.
CRB Review for an IACUC Protocol:
If a study using privately-owned animals requiring CRB review also requires an IACUC protocol, then the “Consent Form Information” option should be chosen, and the consent form should be attached to KP. Final protocol approval in KP will not occur until the CRB has reviewed and approved the consent form.
If there are any changes to an approved IACUC Waiver or Protocol using privately-owned animals, an amendment needs to be submitted through KP. 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.
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 within 5 days.
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 Best Practices page