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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 Approved  as standard on 10/30/09

2

Adverse Events

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

2

Enrollment

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

2

Medical History

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

2

Participant Identifier

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

2

Physical Exam

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

2

Protocol Deviations

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

2

Registration

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

3

Agents Vocabulary

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

3

Agent Study Administration

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

3

Drug Accountability

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

3

Concomitant Medications

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

3

Pre & Post Treatment

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

3

Laboratory Tests & Results

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

3

Outcome Measures

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

3

Outcome Measures Glossary

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

3

Staging & Extent of Disease

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

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

...