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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 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 & 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 in the process for standardization, and undergoing 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 and is being 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 modules have been reviewed by the Community and is in progress for CTROC review and approval, presented to CTROC, and are undergoing final review by specific groups in the cancer clinical trials community.

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 2009February 2010.

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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