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Harmonization/Standardization Process
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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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Round 2 included Adverse Events, Baseline Assessment, Participant Identification, Registration & Enrollment, and Protocol Deviations. Seven modules were completed from those 5 areas, which are Adverse Events, Medical History, Physical Exam, Participant Identification, Registration, Enrollment, and Protocol Deviations. These seven modules have been vetted by the Community and approved by CTROC. In the spring of 2010 the seven modules entered expanded community review. Community review completed three rounds of evaluation through 2010 and in March of 2011 was forwarded to NCI leadership for finalization.
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The Round 4 modules: Header Information, Imaging/Radiology, Non-agent Study Interventions, Diagnosis/Pathology, Vital Signs, Eligibility Criteria, and Off Treatment/Off Study have completed the first round of harmonization in small workgroups. They will enter expanded community review upon the completion of Round 3 content, sometime in the spring of 2011.
Round 5 modules have not been identified at this point, but most likely will include Imaging variables, specifically Recist criteria. Additional content will be identified following a gap analysis once Round 4 work is complete.
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The general metrics from the Round 4 CRF Inventory include:
17 Contributing Organizations
Contributing Organizations: CCR, DCP, University of Pennsylvania, CDASH, NCCTG, CTMS Theradex, CIP (FIMSO), UCSD, CALGB, COH, ACOSOG, Duke, ACRIN, ECOG, University of Michigan, Baylor College of Medicine, and RTOG
237 Case Report Forms
7697 variables (total)
More metrics on the CRFs, variables and modules will be posted on this page and the Project Metrics page.
CRF Project Wiki Child Pages
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