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CRF Modules

Round #

Current Status of Module

Adverse Events

2

Internal Harmonization complete; Expanded Committee Review completed.

Base Intervention

3

Internal Harmonization complete; Expanded Committee Review in session.

Concomitant Medication Agents 

3

Internal Harmonization complete; Expanded Committee Review in session.

Consent

4

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

Demography

1

Harmonization complete; Approved as standard on NCI CRFs.

Diagnosis & Pathology

4

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

Drug Accountability

3

Internal Harmonization complete; Expanded Committee Review in session.

Eligibility Criteria

4

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

End of Form

3

Internal Harmonization complete; Expanded Committee Review in session.

Enrollment

2

Internal Harmonization complete; Expanded Committee Review completed.

Footer

3

Internal Harmonization complete; Expanded Committee Review in session.

Header Information

3

Internal Harmonization complete; Expanded Committee Review in session.

Imaging & Radiology

4

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

Laboratory Tests & Results

3

Internal Harmonization complete; Expanded Committee Review in session.

Medical History

2

Internal Harmonization complete; Expanded Committee Review completed.

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

3

Internal Harmonization complete; Expanded Committee Review in session.

Participant Identifier

2

Internal Harmonization complete; Expanded Committee Review completed.

Physical Exams

2

Internal Harmonization complete; Expanded Committee Review completed.

Pre & Post Treatment Agents 

3

Internal Harmonization complete; Expanded Committee Review in session.

Protocol Deviations

2

Internal Harmonization complete; Expanded Committee Review completed.

Registrations

2

Internal Harmonization complete; Expanded Committee Review completed.

Screening

4

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

Staging & Extent of Disease

3

Internal Harmonization complete; Expanded Committee Review completed.

Study Agent Administration

3

Internal Harmonization complete; Expanded Committee Review in session.

Vital Signs

4

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

Column
Section

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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