| Category |
Select the category. |
Required
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.
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