Submitting a Study for Continuing Review

OVERVIEW

This Quickguide provides Network Group coordinating office staff and Study Chairs with an overview of the continuing review process.
 

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.

Starting a New Worksheet in IRBManager

OVERVIEW

This Quickguide explains how to start a new Worksheet associated with your Signatory Institution in IRBManager.

BEFORE YOU BEGIN

  • You must have an active Cancer Therapy Evaluation Program (CTEP) Identity and Access Management (IAM) account.
  • You must have an assigned role on the CIRB roster for your Signatory Institution to view Worksheets associated with your Signatory Institution.
  • If you are an NCI Division of Cancer Prevention (DCP) Consortia or CP-CTNet site, go to

Reporting Audit Findings

OVERVIEW

This Quickguide provides instructions for reporting audit findings to the CIRB as potential serious or continuing noncompliance.

BEFORE YOU BEGIN

  • Collect the audit report, the response to the audit report, and the management plan that outlines how the findings will be addressed and future occurrences prevented.

Finding Completed Worksheets In IRBManager

OVERVIEW

This Quickguide explains how to find and view completed Worksheets associated with your Signatory Institution in IRBManager.

BEFORE YOU BEGIN

  • You must have an active Cancer Therapy Evaluation Program (CTEP) Identity and Access Management (IAM) account.
  • You must have an assigned role on the CIRB roster for your Signatory Institution to view Worksheets associated with your Signatory Institution.
  • If you are at anNCI Division of Cancer Prevention (DCP) Consortia or CP-CTNet site, go to

Determining Waiver Of Consent Requirements

When a request is made, the CIRB makes the determination of whether a waiver of consent can be utilized.  The waiver of consent is documented in the Approval Letter. For more information, go to the Completing the Waiver of Consent Worksheet.

There are two types of waivers:

  1. Waiver or Alteration of Regulatory Elements of Informed Consent
  2. Waiver of Documentation of Informed Consent.

For more information about each of these types, see the “Key Points” section below.

Copying Worksheets In IRBManager

OVERVIEW

This Quickguide explains how to find and copy a completed Worksheet associated with your Signatory Institution in IRBManager.

BEFORE YOU BEGIN

  • You must have an active Cancer Therapy Evaluation Program (CTEP) Identity and Access Management (IAM) account. 
  • You must have an assigned role on the CIRB roster for your Signatory Institution to view Worksheets associated with your Signatory Institution.
  • If you are at an NCI Division of Cancer Prevention (DCP) Consortia or CP-CTNet site, go to

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