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OnCore: DFD - Precision Trial Classification

Data Field definition table that includes the field name, definition, entry instructions
Field Name Definition Requirement
Entry Instructions
Responsible for Entry QA
Precision Trial Classification If Precision Trial is set to Yes, users can set a value in this field to further classify the precision trial. They can choose from the following options:
  • Basket, for trials that allow the study of multiple molecular subpopulations of different tumor or histologic types all within one study. These trials can include highly rare cancers that would be difficult to study in randomized controlled trials, and they might include multiple treatments by which subjects are matched based on gene expression.
  • Umbrella, for trials using a design that focuses on a single tumor type or histology. It involves a group of two or more enrichment designs, or sub-studies, that are connected through a central infrastructure that oversees screening and identification of patients.
  • Target, for trials designed to evaluate treatments targeted at one or two molecular populations in single or multiple disease type.
  • Other Adaptive Trials, for other studies believed to be precision medicine trials based on non-traditional study design not identified above, limited inclusion criteria, and emphasis on patient-centric treatment.
Not required PC Console edit / Protocol Coordinator No

Keywordsclassification   Doc ID101742
OwnerMolly H.GroupSMPH Research Informatics
Created2020-05-06 10:44:25Updated2024-01-03 13:45:08
SitesInstitute for Clinical and Translational Research, SMPH Research Informatics
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