CACTIS - Application

Renewal/Amendments Process

All studies submitted through CACTIS must have a current IRB approval and stamped consent on file at all times. If there are NO changes to the CT PORTION of the study protocol, please forward the new IRB approvals when the continuing review is completed. Please submit all amendments that involve only the CT portion of the study to the committee when received by the principal investigator. These will need to be approved by the committee before the changed research can be put into effect in the clinical setting.

Amendment submissions

Human Studies:

  • CACTIS application form
  • A copy of the IRB re-approval letter
  • IRB approved consent form (if no changes, please submit just the stamped page)
  • A copy of the IRB continuing review form
  • CT Protocol with tracked changes
  • Protocol summary (only if changes occurred from previous year)
  • Protocol amendments (if applicable)
  • Outline of changes to the protocol

Animal Studies:

  • CACTIS application form
  • A copy of the IACUC re-approval letter
  • A copy of the new animal transfer letter
  • CT Protocol with tracked changes
  • Protocol amendments (with outlined changes)

Specimen/Phantom Studies:

  • CACTIS application form
  • A copy of the IRB re-approval letter Protocol amendments (with outlined changes)
  • Protocol summary
  • CT Protocol with tracked changes
  • Specimen studies: documentation for obtaining specimens

Amendments may be submitted to the CACTIS coordinator. Please submit at least six weeks prior to study end date.