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The CRF Harmonization and Standardization initiative has undertaken the task of harmonizing and standardizing case report forms for cancer clinical trials by first dissecting the CRF into modules and tackling smaller sections of the CRF 5 areas at a time.   The general process includes collecting an inventory of forms related to the information generally captured in that module, for example, On-Study Forms are collected to collected to gather Agent information.   The group then goes through all the forms and identifies those fields that are relevant to that module (area), partitions the fields as either Mandatory, Conditional or Optional, and then identifies appropriate Common Data Elements (CDEs) or creates new CDEs to accurately capture the metadata for the harmonized fields.   Once the group identifies all the fields and CDEs to be collected in that module, these are sent to the Clinical Trials Community for review and comment, the comments are addressed, and the final list of fields are presented to the Clinical & Translational Research Operating Committee (CTROC) for final approval.   After CTROC approval, the CDEs are brought to the Vocabularies & Common Data Elements (VCDE) Workspace for review as caBIG Standards.   Once the CDEs are made standard, the module is officially available for use on cancer clinical trials.

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The first Round of the CRF Harmonization & and 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 the CDEs have been made standard.   The module is 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.   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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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 Metrics Child Page: https://wiki.nci.nih.gov/display/CTMS/CRF+Project+Metrics Project Metrics page.

CRF Project Wiki Child Pages

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