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Module Status Table

Round of Harmonization & Standardization

CRF Modules

Current Status of Module

1

Demography

Harmonization complete; Approved  as standard on 10/30/09

2

Adverse Events

Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.

2

Enrollment

Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.

2

Medical History

Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.

2

Participant Identifier

Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.

2

Physical Exam

Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.

2

Protocol Deviations

Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.

2

Registration

Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.

3

Agents Vocabulary

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Agent Study Administration

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Drug Accountability

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Concomitant Medications

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Pre & Post Treatment

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Laboratory Tests & Results

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Outcome Measures

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Outcome Measures Glossary

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Staging & Extent of Disease

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

4

Diagnosis & Pathology

Internal Harmonization is complete complete; Expanded Committee Review will follow Round 3.

4

Eligibility Criteria

Internal Harmonization is complete complete; Expanded Committee Review will follow Round 3.

4

Header Information

Internal Harmonization is complete complete; Expanded Committee Review will follow Round 3.

4

Imaging & Radiology

Internal Harmonization is complete currently underway.

4

Non- Agent Study Interventions

Internal Harmonization is complete complete; Expanded Committee Review will follow Round 3.

4

Off Treatment_Off Study

Internal Harmonization is complete complete; Expanded Committee Review will follow Round 3.

4

Screening

Internal Harmonization is complete complete; Expanded Committee Review will follow Round 3.

4

Consent

Internal Harmonization is complete complete; Expanded Committee Review will follow Round 3.

4

Vital Signs

Internal Harmonization is complete complete; Expanded Committee Review will follow Round 3.

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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