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Page History
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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:
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Step
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Action
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1
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NCI CBIIT staff create CRF inventory
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2
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Working group aggregates and identifies key content, resolves discrepancies, harmonizes - expansion in working group membership to include named point of contacts (POCs) for all major internal and external clinical trial stakeholders
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3
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Working group partitions content - mandatory, conditional, optional
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4
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Working group achieves consensus on final list of elements, assures adherence to data standards
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5
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Executive summary sent to Clinical and Translational Research Operations Committee (CTROC)
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6
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Module circulated for broad community review
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7
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Working group reviews and responds to changes from community review - POCs for all major internal and external clinical trial stakeholders provide formal approval of CRF elements prior to subsequent review
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8
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CRF Subcommittee of the CTMS Steering Committee reviews and approves - newly formed subcommittee ensures review by critical external clinical trial stakeholders, e.g., NCI cooperative groups
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9
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CTROC reviews and approves
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10
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Status of CRF Activities
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.
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