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 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.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 Internal Harmonization complete; Expanded Committee Review in session

Final

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

Header Information

3 Internal Harmonization complete; Expanded Committee Review in session

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.