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Page History
Round | CRF Modules | Current Status of Module |
|---|---|---|
1 | Harmonization complete: ; Standards presentation 9/3/09, pending final approval | |
2 | Adverse Events Preparing | submission to the VCDE Workspace for CDE Review Harmonization complete; preparing for standards review |
2 | Enrollment Preparing submission to the VCDE Workspace for CDE | Review Harmonization complete; preparing for standards review |
2 | Medical History Preparing | submission to the VCDE Workspace for CDE Review Harmonization complete; preparing for standards review |
2 | Participant Identifier Preparing | submission to the VCDE Workspace for CDE Review Harmonization complete; preparing for standards review |
2 | Physical Exam Preparing | submission to the VCDE Workspace for CDE Review Harmonization complete; preparing for standards review |
2 | Protocol Deviations Preparing | submission to the VCDE Workspace for CDE Review Harmonization complete; preparing for standards review |
2 | Registration Preparing submission to the VCDE Workspace for CDE | Review Harmonization complete; preparing for standards review |
3 | Agents (Variables & Vocabulary)Preparing documentation for Clinical & Translational Research Operating Committee (NCI Leadership) Review | 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 & ResultsPreparing documentation for Clinical & Translational Research Operating Committee (NCI Leadership) Review | Harmonization nearing completion |
3 | Harmonization nearing completion | |
3 | Outcome Measures Glossary | Harmonization nearing completion 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 | Harmonization nearing completion |
4 | Diagnosis & Pathology Workgroups are meeting to harmonize module content | Harmonization in progress, in workgroup meetings |
4 | Eligibility Criteria Workgroups are meeting to harmonize module content | Harmonization in progress, in workgroup meetings |
4 | Header Information Workgroups are meeting to harmonize module content | Harmonization in progress, in workgroup meetings |
4 | Imaging & Radiology Workgroups are meeting to harmonize module content | Harmonization in progress, in workgroup meetings |
4 | Non- Agent Study Interventions Workgroups are meeting to harmonize module content | Harmonization in progress, in workgroup meetings |
4 | Off Treatment_Off Study Workgroups are meeting to harmonize module content | Harmonization in progress, in workgroup meetings |
4 | Vital Signs Workgroups are meeting to harmonize module content | 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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