OVERVIEW

This Quickguide provides instructions for completing the Unanticipated Problem and/or the Serious or Continuing Noncompliance (UP/SCN) Submission Application.

OVERVIEW

This Quickguide provides instructions for Study Teams/CTSU to complete the Translation Application.

OVERVIEW

This Quickguide provides instructions for completing the Waiver of Consent (WoC) Application.

BEFORE YOU BEGIN

• Consider printing a copy of the Waiver of Consent Request Supplemental Form to use as reference as you complete the Application in IRBManager.
• Review the Determining Waiver of Consent Requirements Quickguide to determine if a waiver of consent is appropriate.

This document outlines the different kinds of submissions for the review of translations and the submission requirements for each type of document.

Consent Forms

NCTN and NCORP study consent forms are translated by the CTSU into Spanish and submitted to the CIRB by the CTSU for the Study Team.  These submissions require a translated Spanish version of the CIRB-approved English consent form and a Certificate of Accuracy.  And a completed Translation Application.

OVERVIEW

This Quickguide provides instructions to Study Chairs/Coordinating Centers for submitting Recruitment/Participant Materials for review.  Recruitment/Particitpant materials may include, but are not limited to, the following:

OVERVIEW

BEFORE YOU BEGIN

• The Study Chair/Coordinating Center submits the study amendment to the Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP) for scientific review.  Once approved by CTEP or DCP, an Approval on Hold (AOH) Letter is emailed to the Study Chair and the CIRB.

OVERVIEW

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 is completed in IRBManger by the Principal Investigator (PI) or PI’s designee.
• Confirm that all criteria are met for study closure or transfer listed in the Wo

SOME OF YOUR FREQUENTLY ASKED QUESTIONS:

WHEN CAN I USE A TRANSLATED SHORT FORM TO OBTAIN CONSENT?

You may use a translated short form if all the following conditions are met:

OVERVIEW

This instruction provides an overview of the process for enrolling as a Signatory Institution with the CIRB. Enrollment occurs in two parts: Part 1 establishes the institutional framework, and Part 2 establishes local context. Part 1 must be completed before progressing to Part 2.

This Quickguide explains how to enroll as a Signatory Institution with the CIRB. Enrollment occurs in two parts: Part 1 establishes the institutional framework, and Part 2 establishes local context.  Part 1 must be completed before progressing to Part 2.