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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 and is being prepared for standardization review..  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. 

Round 3 modules include Agents (looking at both standardizing vocabulary and the variables to be collected), Laboratory Tests/Results, Outcome Measures, and Staging/Extent of Disease.  These modules have been reviewed by the Community, presented to CTROC, and are undergoing final review by specific groups in the cancer clinical trials community.  It is anticipated that this set of content will be finalized in April of 2011.

The Round 4 modules: Header Information, Imaging/Radiology, Non-agent Study Interventions, Diagnosis/Pathology, Vital Signs, Eligibility Criteria, and Off Treatment/Off Study are in harmonization progress via the CRF Workgroups.  They are scheduled to finish by early February 2010.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. 

Metrics

The CRF Harmonization & Standardization project was initiated to provide a harmonized and standardized set of variables to be collected for oncology clinical trials that could be implemented to facilitate data entry, and study aggregation, comparison and analysis. The CRF collection process for Rounds 1-3 only collected Case Report Forms specific for that module. However, prior to Round 4, the Workgroup Leads recommended collecting CRFs for all areas and doing a single CRF inventory for all remaining modules, current and future Rounds.

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