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Module Status Table

CRF Modules	Round of Harmonization & Standardization	Current Status of Module
Adverse Events	2	Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.
Agent Study Administration	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Agents Vocabulary	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Concomitant Medications	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Consent	4	Internal Harmonization complete; Expanded Committee Review will follow Round 3.
Demography	1	Harmonization complete; Approved as standard on 10/30/09
Diagnosis & Pathology	4	Internal Harmonization complete; Expanded Committee Review will follow Round 3.
Drug Accountability	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Eligibility Criteria	4	Internal Harmonization complete; Expanded Committee Review will follow Round 3.
Enrollment	2	Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.
Header Information	4	Internal Harmonization complete; Expanded Committee Review will follow Round 3.
Imaging & Radiology	4	Internal Harmonization currently underway.
Laboratory Tests & Results	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Medical History	2	Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.
Non- Agent Study Interventions	4	Internal Harmonization complete; Expanded Committee Review will follow Round 3.
Off Treatment_Off Study	4	Internal Harmonization complete; Expanded Committee Review will follow Round 3.
Outcome Measures Glossary	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Outcome Measures	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Participant Identifier	2	Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.
Physical Exam	2	Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.
Pre & Post Treatment	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Protocol Deviations	2	Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.
Registration	2	Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.
Screening	4	Internal Harmonization complete; Expanded Committee Review will follow Round 3.
Staging & Extent of Disease	3	Internal Harmonization complete; Expanded Committee Review will follow Round 2.
Vital Signs	4	Internal Harmonization complete; Expanded Committee Review will follow Round 3.

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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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