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Round

CRF Modules

Current Status of Module

1

Demography

Under review by the VCDE Workspace

2

Adverse EventsComplete

Preparing submission to the VCDE Workspace for CDE Review

2

Enrollment

Preparing submission to the VCDE Workspace for CDE Review

2

Medical History

Preparing submission to the VCDE Workspace for CDE Review

2

Participant Identifier

Preparing submission to the VCDE Workspace for CDE Review

2

Physical Exam

Preparing submission to the VCDE Workspace for CDE Review

2

Protocol Deviations

Preparing submission to the VCDE Workspace for CDE Review

2

Registration

Preparing submission to the VCDE Workspace for CDE Review

3

Agents (Variables & Vocabulary)

Complete

Preparing documentation for Clinical & Translational Research Operating Committee (NCI Leadership) Review

3

Laboratory Tests & Results

Preparing documentation for Clinical & Translational Research Operating Committee (NCI Leadership) Review

3

Outcome Measures

Preparing documentation for Clinical & Translational Research Operating Committee (NCI Leadership) Review

3

Staging & Extent of Disease

Preparing documentation for Clinical & Translational Research Operating Committee (NCI Leadership) Review

1

Demography

Complete

4

Diagnosis & PathologyActive-In Working Group

Workgroups are meeting to harmonize module content

4

Eligibility Criteria

Active-In Working Group

2

Enrollment

Complete

Workgroups are meeting to harmonize module content

4

Header InformationActive-In Working Group

Workgroups are meeting to harmonize module content

4

Imaging & Radiology

Active-In Working Group

3

Laboratory Tests & Results

Complete

2

Medical History

Complete

Workgroups are meeting to harmonize module content

4

Non- Agent Study InterventionsActive-In Working Group

Workgroups are meeting to harmonize module content

4

Off Treatment_Off Study

Active-In Working Group

3

Outcome Measures

Complete

2

Participant Identifier

Complete

2

Physical Exam

Complete

2

Protocol Deviations

Complete

2

Registration

Complete

3

Staging & Extent of Disease

Complete

Workgroups are meeting to harmonize module content

4

Vital SignsActive-In Working Group

Workgroups are meeting to harmonize module content

Introduction

The Standardized Case Report Form (CRF) Work Group is focused on establishing a core library of harmonized and standardized Phase II and III CRFs and data collection modules through stakeholder consensus. A core library of harmonized and standardized CRFs will be highly valuable to the cancer clinical trials community because it will provide a standardized mechanism for comparing and aggregating information across the NCI's clinical trial portfolio. Additionally, a harmonized CRF library will improve the efficiency and accuracy of the routine review of safety, efficacy, and administrative data from ongoing NCI-funded clinical trials. Finally, by reducing the time spent in developing a data collection strategy per trial, this core library will allow for faster initiation of new trials; thus, speeding the process of delivering new and improved treatments to patients.

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