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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. | |
4 | Final | Total of 6 CDEs built in one CRF standard module. | |
| CT Image Acquisition | 5 | Under Review | |
| CT Image Administration | 5 | Under Review | |
1 | Final | Total of 15 CDEs built in one CRF standard module. | |
4 | Final | Total of 8 CDEs built in one CRF standard module. | |
4 | Final | Total of 6 CDEs built in one CRF standard module. | |
| Diagnosis/Pathology | 5 | Under Review | |
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 | Final | Total of 8 CDEs built in one CRF standard module. | |
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 | Final | Total of 10 CDEs built in one CRF standard module. | |
| Follow-up | 5 | Under Review | |
3 | Final | Total of 5 CDEs built in one CRF standard module. | |
| Gross Tumor | 5 | Under Review | |
3 | Final | Total of 11 CDEs built in one CRF standard module. | |
4 | Final | Total of 7 CDEs built in one CRF standard module. | |
3 | Final | Total of 14 CDEs built in one CRF standard module. | |
| Lost to Follow-up | 5 | Under Review | |
| Metastasis | 5 | Under Review | |
2 | Final | Total of 7 CDEs built in one CRF standard module. | |
| Microscopic Histology | 5 | Under Review | |
3 | Not Needed - Removed | The outcome module was created in round 2. At the time of delivery the limitations in the content were recognized, and we had a plan to expand the content at some point and also look mainly at response results in nonsolid tumors, like the leukemias and lymphomas. So round 5 was envisioned as expanding two main areas in round 2 – 1) responses had to be expanded beyond the solid tumors, and 2) survival had to be expanded. Therefore, Outcomes in round 2 have now been replaced by content in round 5. | |
4 | Final | Total of 3 CDEs built in one CRF standard module. | |
4 | Final | Total of 3 CDEs built in one CRF standard module. | |
2 | Final | Total of 10 CDEs built in one CRF standard module. | |
4 | Final | Draft New CRF standard module undergoing community review and vetting. | |
4 | Final | Total of 2 CDEs built in one CRF standard module. | |
4 | Final | Draft New CRF standard module undergoing community review and vetting. | |
4 | Final | Total of 7 CDEs built in one CRF standard module. | |
| Progression | 5 | Under Review | |
2 | Final | Total of 6 CDEs built in one CRF standard module. | |
3 | Final | Total of 14 CDEs built in one CRF standard module. | |
| Procedures/Results | 5 | Under Review | |
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 | Final | Total of 30 CDEs built in one CRF standard module. | |
| RECIST | 5 | Under Review | |
2 | Final | Total of 19 CDEs built in one CRF standard module. | |
| Response | 5 | Under Review | |
4 | Final | Total of 4 CDEs built in one CRF standard module. | |
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 | Total of 31 CDEs built in one CRF standard module. | |
| Survival | 5 | Under Review | |
4 | Final | Total of 24 CDEs built in one CRF standard module. |
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