Managing Your CTEP Registration

OVERVIEW

This Quickguide address the Cancer Therapy Evaluation Program (CTEP) registration requirement.  All Signatory, Component and Affiliate Institutions and supporting staff on the CIRB roster are required to register with the Cancer Therapy Evaluation Program (CTEP).  The steps for applying for a new CTEP side code, CTEP person ID, Identify and Access Management (IAM) account and managing existing CTEP site code, CTEP person ID, and IAM account are detailed below:

CIRB Document Posting

As of December 15, 2017, all documents posted to the CSTU website will be posted only once for ease of access and simplification of posting.  All documents reviewed by the CIRB will continue to be listed in the outcome letter but those documents provided to the CIRB for reference and posted in other locations on the CTSU website will not be duplicated.

Below is a summary of documents which will be made available via the CIRB Documents tab.

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.