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Module status Table

Some text.

Introduction

Some level two text.

Harmonization & Standardization

Second level two text.

Status of CRF activities

Second and last level one text.

Round of Harmonization & Standardization

CRF Modules

Current Status of Module

1

Demography

Harmonization complete; Standards presentation 9/3/09, pending final approval

2

Adverse Events

Harmonization complete; preparing for standards review

2

Enrollment

Harmonization complete; preparing for standards review

2

Medical History

Harmonization complete; preparing for standards review

2

Participant Identifier

Harmonization complete; preparing for standards review

2

Physical Exam

Harmonization complete; preparing for standards review

2

Protocol Deviations

Harmonization complete; preparing for standards review

2

Registration

Harmonization complete; preparing for standards review

3

Agents Vocabulary

Harmonization nearing completion

3

Study Administration

Harmonization nearing completion

3

Drug Accountability

Harmonization nearing completion

3

Concomitant Medications

Harmonization nearing completion

3

Pre/Post Treatment

Harmonization nearing completion

3

Laboratory Tests & Results

Harmonization nearing completion

3

Outcome Measures

Harmonization nearing completion

3

Outcome Measures Glossary

Harmonization nearing completion

3

Staging & Extent of Disease

Harmonization nearing completion

4

Diagnosis & Pathology

Harmonization in progress, in workgroup meetings

4

Eligibility Criteria

Harmonization in progress, in workgroup meetings

4

Header Information

Harmonization in progress, in workgroup meetings

4

Imaging & Radiology

Harmonization in progress, in workgroup meetings

4

Non- Agent Study Interventions

Harmonization in progress, in workgroup meetings

4

Off Treatment_Off Study

Harmonization in progress, in workgroup meetings

4

Vital Signs

Harmonization in progress, in workgroup meetings

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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