1

Demography

Harmonization complete; Standards presentation 9/3/09, pending final approval

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

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 in progress, in workgroup meetings

4

Eligibility Criteria

Harmonization in progress, in workgroup meetings

4

Header Information

Harmonization in progress, in workgroup meetings

4

Imaging & Radiology

Harmonization in progress, in workgroup meetings

4

Non- Agent Study Interventions

Harmonization in progress, in workgroup meetings

4

Off Treatment_Off Study

Harmonization in progress, in workgroup meetings

4

Vital Signs

Harmonization in progress, in workgroup meetings