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Module Status Table

CRF Modules

Round #

Current Status of Module

Adverse Events

2

Internal Harmonization complete; Expanded Committee Review in session.

Agent Study Administration

3

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

Concomitant Medication Agents 

3

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

Consent

4

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

Demography

1

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

Diagnosis & Pathology

4

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

Drug Accountability

3

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

Eligibility Criteria

4

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

End of Form

4

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

Enrollment

2

Internal Harmonization complete; Expanded Committee Review in session.

Footer

4

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

Header Information

4

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

Imaging & Radiology

4

Internal Harmonization currently underway.

Laboratory Tests & Results

3

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

Medical History

2

Internal Harmonization complete; Expanded Committee Review in session.

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 will follow Round 2.

Participant Identifier

2

Internal Harmonization complete; Expanded Committee Review in session.

Physical Exams

2

Internal Harmonization complete; Expanded Committee Review in session.

Pre & Post Treatment Agents 

3

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

Protocol Deviations

2

Internal Harmonization complete; Expanded Committee Review in session.

Registrations

2

Internal Harmonization complete; Expanded Committee Review in session.

Screening

4

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

Staging & Extent of Disease

3

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

Vital Signs

4

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

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