Page History

Adverse Events

2

Final

• Total of 31 CDEs built in two CRF standard modules – one to use with CTCAE v3.0 reporting requirements, and one for CTCAE v4.0 reporting requirements. AE modules include Serious Adverse Event (SAE) CDEs.

Base Intervention

3

Not Needed - Removed

• The intent of the Base Interventions module was to group all commonly-used CDEs need for primarily intervention studies.  In one module CDEs for start date, stop date, dose, Unit of measure, dose, etc., were grouped.  Reviewers did not feel this was the best way to categorize the elements.  So the pertinent elements in the Base Interventions module were instead added to each intervention/agent module.  The Base Interventions module is retired, and not part of the final Standard CRF set.

Concomitant Medication Agents

3 Internal Harmonization complete; Expanded Committee Review in session

Final

• Total of 13 CDEs built in one CRF standard module.

Consent

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

Under Review

• Draft New CRF standard module undergoing community review and vetting.

Demography

1 Harmonization complete; Approved as standard on NCI CRFs

Final

• Total of 15 CDEs built in one CRF standard module.

Diagnosis and Pathology

4

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

Drug Accountability

3

Internal Harmonization complete; Expanded Committee Review in session.

Eligibility Criteria

4

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

End of Form

3

Internal Harmonization complete; Expanded Committee Review in session.

Enrollment

2

Internal Harmonization complete; Expanded Committee Review completed.

Footer

3

Internal Harmonization complete; Expanded Committee Review in session.

Header Information

3

Internal Harmonization complete; Expanded Committee Review in session.

Imaging and Radiology

4

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

Laboratory Tests and Results

3

Internal Harmonization complete; Expanded Committee Review in session.

Medical History

2

Internal Harmonization complete; Expanded Committee Review completed.

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 in session.

Participant Identifier

2

Internal Harmonization complete; Expanded Committee Review completed.

Physical Exams

2

Internal Harmonization complete; Expanded Committee Review completed.

Pre and Post Treatment Agents

3

Internal Harmonization complete; Expanded Committee Review in session.

Protocol Deviations

2

Internal Harmonization complete; Expanded Committee Review completed.

Registrations

2

Internal Harmonization complete; Expanded Committee Review completed.

Screening

4

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

Staging and Extent of Disease

3

Internal Harmonization complete; Expanded Committee Review completed.

Study Agent Administration

3

Internal Harmonization complete; Expanded Committee Review in session.

Vital Signs

4

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