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CRF Round 4 Status
The executive documentation relating to Round 4 was sent to NCI leadership on May 1st. The content for Round 4 is now finalized and waiting on NCI approval. Once we receive NCI approval, the CRF team will change the status of the forms in form builder to a released status and post the template downloads for each module on the CRF Wiki.NCI CRF Initiative Round 4 activity was convened in April of 2012. Content identified from candidate CRFs and from the community was placed through iterative and large-scale community review for approval as NCI eCRF data collection standards. Content in Round 4 was delivered from the following workgroups:
- Imaging – total of six modules
- Diagnosis/Pathology – total of two modules
- Study Interventions – total of two modules
- Vital Signs – total of one module
- Eligibility Criteria – total of three modules
- Off Treatment/Off Study – total of two modules
- Header/Footer/End of form – vetted and approved in Round 3 activity
Results from Round 4 work was reviewed and approved by Dr. Robert Gray in May of 2013. At that point the prescribed changes to the 16 modules of content began. This work required the help of multiple curators since the standard elements come from a number of registry contexts. Changes and in some places new CDEs were needed. Once all changes to CDEs were made, the CRF modules were reviewed and revised, then validated again before being released. The final step is a load of the standard templates into the NCI Standard form cart in the caDSR.
Work was originally scheduled to be completed by July 15, 2013, and most of the modules were finished by that date. In a few cases activities to harmonize value sets, define data elements more concisely, add additional elements to imaging modules and revisit the categorization of content in the radiation therapy module required additional time. Reviewers in RTOG, the NCI Cancer Imaging Program (CIP) and the ECOG-ACRIN group were very helpful in making needed revisions to the modules that required select and expert reviewers.
By the close of October 2013 all changes to Round 4 content were completed and reviewed by the NCI CBIIT curation team. CRFs were built in caDSR, the FormBuilder Form cart was updated, and this Wiki were all updated.
Please find below the executive summary for Round 4 which summarizes the deliverables by module.
