Topics Map > OnCore > Data Field Definitions > Non-oncology

Category

Field Name Definition Requirement
Entry Instructions
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Category Select the category. Required
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  • Consent: Deviations related to the consent process and/or consent documents.
  • Eligibility: Deviations related to eligibility criteria.
  • Treatment: Deviations related to drug, device, or biologics treatments given per protocol.
  • Scheduled Test: Deviations related to tests, assessments, and interventions (i.e., non-treatment interventions) required per protocol (Exception: procedures and tests performed to assess treatment response/outcome).
  • Response/Outcome: Deviations related to procedures and tests performed to assess response/outcome. Other: Deviations that do not fit into any other category noted above.
No


Keywords:
Deviation category 
Doc ID:
99554
Owned by:
Molly H. in SMPH Research Informatics
Created:
2020-03-26
Updated:
2022-10-05
Sites:
SMPH Research Informatics