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 Interventions

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

3

Final

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

Consent

4

Under Review

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

Demographics

1

Final

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

Diagnosis (Administrative)

4

Under Review

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

Diagnosis (Intervention)

4

Under Review

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

Drug Compliance

3

Not Needed - Removed

• Review demonstrated that 5 of the 8 CDEs in this module are repeated in the Study Administration CRF module.  So the remaining 3 CDEs were merged with the Study Administration CRF standard module, and the Drug Compliance module removed as a separate CRF module.

Eligibility

4

Under Review

• Draft New CRF standard module undergoing community review and vetting

End of Form

3

Final

• Total of 8 CDEs built in two CRF standard module.

Enrollment

2

Final

• Total of 5 CDEs built in two CRF standard module.

Equipment

4

Under Review

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

Footer

3

Final

• Total of 8 CDEs built in two CRF standard module.

Header Information

3

Final

• Total of 11 CDEs built in two CRF standard module.

Imaging

4

Under Review

• Five (5) Draft New CRF standard modules undergoing community review and vetting.

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

Final

• Total of 14 CDEs built in two CRF standard module.

Medical History

2

Final

• Total of 7 CDEs built in two CRF standard module.

Outcome

3

Under Review

• Results of Round 3 being expanded and revised in Round 5

Internal Harmonization complete; Expanded Committee Review completed.

Non-Agent Study Interventions

4

• .

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.

Under Review

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

Participant Identification

2

Final

• Total of 10 CDEs built in two CRF standard module.

Physical Examination

2

Final

• Total of 6 CDEs built in two CRF standard module.

Prior/Post Therapy Agents

3

Final

• Total of 14 CDEs built in two CRF standard module.

Protocol Violations

2

Final

• Total of 8 CDEs built in one CRF standard module. The use of a Protocol Deviation module is NOT recommended. Deviation data should be recorded in the appropriate form (agent administration, AE, etc.). However, if a sponsor mandates the use of an additional Protocol Deviation module, the identified variables should be used.

Radiation Therapy

4

Under Review

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

Registrations

2

Final

• Total of 19 CDEs built in one CRF standard module.

Screening

4

Under Review

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

Staging/Extent of Disease

3

Final

• Total of 21 separate CRF modules for major disease groups, including Leukemia, Lymphoma, and Solid tumors. There is no generic stage CRF module content. All CRF modules begin with ‘Staging’ and then have the specific diagnostic group. CDEs in these modules are largely but not exclusively based on AJCC edition 7.0 collaborative staging criteria.

Study Agent Administration

3

Final

• Total of 19 CDEs built in one CRF standard module.

Surgery

4

Under Review

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

Vital Signs

4

Under Review

• Draft New CRF standard module undergoing community review and vetting

Vital Signs

4

• .