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Module Status Table

Round of Harmonization & Standardization

CRF Modules

Current Status of Module

1

Demography

Harmonization complete; Standards presentation 9/3/09; Approved CDEs as standard on 10/30/09

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

Agent 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 is complete

4

Eligibility Criteria

Harmonization is complete

4

Header Information

Harmonization is complete

4

Imaging & Radiology

Harmonization is complete

4

Non- Agent Study Interventions

Harmonization is complete

4

Off Treatment_Off Study

Harmonization is complete

4

Screening

Harmonization is complete

4

Consent

Harmonization is complete

4

Vital Signs

Harmonization is complete

...