Page History

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The first Round of the CRF Harmonization & Standardization Project addressed a single module, Demography.  This work began in June 2007, and the module has gone through the the entire process and has been approved by CTROC, and is currently undergoing in the process for standardization, and undergoing implementation/deployment for use in cancer clinical trials.

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 awaiting CTROC approvalbeing prepared for standardization review.

The Working Groups, comprised of a diverse group of individuals from the cancer clinical trials community are currently harmonizing modules for Round 3.  The Community consists of individuals from various divisions with NCI, clinicians, physicians, data managers, and statisticians from cancer centers and pharmaceutical companies involved in clinical trials.  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 groups are still harmonizing their inventory of CRFs and identifying/creating CDEs for the harmonized fieldsmodules have been reviewed by the Community and is in progress for CTROC review and approval.

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 November 2009.

Module Child Pages