Completing The Annual Signatory Institution Worksheet

OVERVIEW

This Quickguide provides instructions for completing the Annual Signatory Institution Worksheet.

BEFORE YOU BEGIN

  • Consider printing a copy of the Worksheet by clicking here to use as reference as you complete the Worksheet in IRBManager.
  • The Worksheet should be completed by the Signatory Institution Primary Contact or designee.
  • Use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to change the auto-populated information relating to the person submit

Determining Assent Requirements

The CIRB makes the determination of assent requirements for any study enrolling children.  The assent requirements are documented in the Approval Letter.

Assent Requirements

For each study enrolling children, the CIRB determines assent requirements, including age ranges when the child’s assent is required. The assent requirements are documented in the “outcome letter” that the CIRB issues when approving a study.