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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.

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

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 the CDEs have been made standard.  The module is undergoing implementation/deployment for use in cancer clinical trials.

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