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Page History
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CRF Modules | Round # | Status | Status Description |
|---|---|---|---|
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. |
3 | Final | Total of 13 CDEs built in one CRF standard module. | |
4Under Review | Final | Draft New CRF standard module undergoing community review and vetting. | |
1 | Final | Total of 15 CDEs built in one CRF standard module. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
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. |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting | |
3 | Final | Total of 8 CDEs built in one CRF standard module. | |
2 | Final | Total of 5 CDEs built in one CRF standard module. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
3 | Final | Total of 5 CDEs built in one CRF standard module. | |
3 | Final | Total of 11 CDEs built in one CRF standard module. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
3 | Final | Total of 14 CDEs built in one CRF standard module. | |
2 | Final | Total of 7 CDEs built in one CRF standard module. | |
3 | Under Review | Results of Round 3 being expanded and revised in Round 5. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
2 | Final | Total of 10 CDEs built in one CRF standard module. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
2 | Final | Total of 6 CDEs built in one CRF standard module. | |
3 | Final | Total of 14 CDEs built in one CRF standard module. | |
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. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
2 | Final | Total of 19 CDEs built in one CRF standard module. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
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. | |
3 | Final | Total of 19 CDEs built in one CRF standard module. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. | |
4 | Under Review | Draft New CRF standard module undergoing community review and vetting. |
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In October of 2009, the need for an Expanded Committee Review was identified. A change in the community review process was instituted in the Spring of 2010. The revised process is as follows:
Status of CRF Activities
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