OnCore: DFD - Precision Trial

Data Field definition table that includes the field name, definition, entry instructions
Field Name Definition Requirement
Entry Instructions
Responsible for Entry QA
Precision Trial Indicates whether the protocol uses precision medicine.

Oncology:Required


Select 'Yes' if one of the following criteria is met:

  • If the eligibility criteria for any treatment-specific portion of the trial requires a specific DNA or RNA alteration (e.g., amplification, deletion, fusion, mutation) that is either germline or somatic in order to be eligible for the study
  • A non-treatment protocol designed to identify an actionable agent (DNA or RNA amplification, deletion, fusion or mutation) in order to identify subjects as potential eligible for another treatment trial.


Note: For studies that stratify patients based on a mutation status to be present or absent in order to be eligible for the trial, the precision question should be answered 'No'.

Non-oncology: Not required

PC Console edit / Protocol Coordinator No


Keywords:
precision trial 
Doc ID:
101740
Owned by:
Molly H. in SMPH Research Informatics
Created:
2020-05-06
Updated:
2024-01-03
Sites:
SMPH Research Informatics