OVERVIEW

This Quickguide provides an algorithm to assess whether or not an incident is reportable to the CIRB as a potential unanticipated problem.

OVERVIEW

BEFORE YOU BEGIN

• The Network Group coordinating office staff receives a reminder email  and access to the online continuing review application in IRBManager from the CIRB. The email and application indicates the study's expiration date and the application due date.

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