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Part 2: Documenting Local Context

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.

Part 1: Applying For Membership

OVERVIEW

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.

Boilerplate Language Q & A

SOME OF YOUR FREQUENTLY ASKED QUESTIONS:

Establishing Your Signatory Institution

OVERVIEW

The Annual Signatory Institution Worksheet provides the information that defines the “local context” for all research conducted under the authority of the Signatory Institution and covered by the CIRB. This is the mechanism that allows the institution to utilize the NCI CIRB as its IRB of record. This Quickguide outlines the steps for establishing the local context considerations for your Signatory Institution with the CIRB.

Institutions' Roles With The CIRB

OVERVIEW

This Quickguide describes Signatory Institutions, Component Institutions, and Affiliate Institutions.

Guidelines For Permitted Boilerplate Language Additions

OVERVIEW

The National Cancer Institute’s (NCI’s) goal is to limit changes to the model consent form, and to ensure that any information added to the form is related to research specific to NCI-funded studies (New Guidelines For Permitted Boilerplate Language Additions).

Completing the Annual Principal Investigator Worksheet

OVERVIEW

This Quickguide provides instructions for completing the Annual Principal Investigator 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 Principal Investigator (PI) or PI’s designee.
You will use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to make any changes to the auto-popul

Establishing a Principal Investigator

OVERVIEW

This Quickguide outlines the steps for establishing the local context considerations for a Principal Investigator (PI) with the CIRB.

BEFORE YOU BEGIN

You’ll want to be sure that your Signatory Institution has a completed Enrollment Form and an executed Authorization Agreement.
The RUMS Update Person needs to add the PI to the CIRB’s roster using the Roster Update Maintenance System (RUMS).

Creating and Updating the Annual Principal Investigator Worksheet

Completing your Annual Principal Investigator Worksheet

The following is a list of how-to quickguides are designed to assist you in completing your Annual Principal Investigator Worksheet, either for the first time or as an update based on a change to your local context considerations.

When To Use NCI CIRB, IRBManager, and CTSU Websites

The NCI CIRB posts information to NCI CIRB, IRBManager, and CTSU websites. These websites provide different levels of information and support for CIRB users.

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