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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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