Category (Deviation Tab)

Field Name Definition Requirement
Entry Instructions		 Responsible for Entry QA
Category Drop down menu option definitions:
  • 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.
 Required

Select the appropriate category.		 No

Keywords:
Deviation category
Doc ID:
99554
Owned by:
Ilsa G. in SMPH Research Applications
Created:
2020-03-26
Updated:
2026-01-13
Sites:
SMPH Research Applications