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Module Status Table

CRF Modules

Round of Harmonization & Standardization

CRF Modules

Current Status of Module

1

Demography

Harmonization complete; Approved  as standard on 10/30/09

2

Adverse Events

Adverse Events

2

Internal Harmonization complete; Expanded Committee Review scheduled for March 2010.

2

Agent Study Administration

Enrollment

3

Internal Harmonization complete; Expanded Committee Review

scheduled for March 2010

will follow Round 2.

2

Agents Vocabulary

Medical History

3

Internal Harmonization complete; Expanded Committee Review

scheduled for March 2010

will follow Round 2.

2

Concomitant Medications

Participant Identifier

3

Internal Harmonization complete; Expanded Committee Review

scheduled for March 2010

will follow Round 2.

2

Consent

Physical Exam

4

Internal Harmonization complete; Expanded Committee Review

scheduled for March 2010.

2

Protocol Deviations

will follow Round 3.

Demography

1

Harmonization complete; Approved  as standard on 10/30/09

Diagnosis & Pathology

4

Internal Harmonization complete; Expanded Committee Review

scheduled for March 2010

will follow Round 3.

2

Drug Accountability

Registration

3

Internal Harmonization complete; Expanded Committee Review

scheduled for March 2010

will follow Round 2.

3

Eligibility Criteria

Agents Vocabulary

4

Internal Harmonization complete; Expanded Committee Review will follow Round

2

3.

3

Enrollment

Agent Study Administration

2

Internal Harmonization complete; Expanded Committee Review

will follow Round 2

scheduled for March 2010.

3

Header Information

Drug Accountability

4

Internal Harmonization complete; Expanded Committee Review will follow Round

2

3.

Imaging & Radiology

4

Internal Harmonization currently underway.

3

Concomitant Medications

Laboratory Tests & Results

3

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

3

Pre & Post Treatment

Medical History

2

Internal Harmonization complete; Expanded Committee Review

will follow Round 2

scheduled for March 2010.

3

Laboratory Tests & Results

Non- Agent Study Interventions

4

Internal Harmonization complete; Expanded Committee Review will follow Round

2

3.

3

Outcome Measures

Off Treatment_Off Study

4

Internal Harmonization complete; Expanded Committee Review will follow Round

2

3.

3

Outcome Measures Glossary

3

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

Outcome Measures

3

Staging & Extent of Disease

Internal Harmonization complete; Expanded Committee Review will follow Round 2.

4

Diagnosis & Pathology

Participant Identifier

2

Internal Harmonization complete; Expanded Committee Review

will follow Round 3

scheduled for March 2010.

4

Physical Exam

Eligibility Criteria

2

Internal Harmonization complete; Expanded Committee Review

will follow Round 3

scheduled for March 2010.

4

Header Information

Pre & Post Treatment

3

Internal Harmonization complete; Expanded Committee Review will follow Round

3

2.

4

Imaging & Radiology

Protocol Deviations

2

Internal Harmonization

currently underway.

4

Non- Agent Study Interventions

Internal Harmonization

complete; Expanded Committee Review

will follow Round 3

scheduled for March 2010.

4

Off Treatment_Off Study

Registration

2

Internal Harmonization complete; Expanded Committee Review

will follow Round 3.

scheduled for March 2010.

Screening

4

Screening

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

4

Staging & Extent of Disease

3

Consent

Internal Harmonization complete; Expanded Committee Review will follow Round

3

2.

4

Vital Signs

4

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

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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