C164348Level 6

Study Procedure Deviation

**Semantic type:** Conceptual Entity

**Definition:** An indication that a protocol deviation involved the trial processes or procedures defined in the study protocol.

**Synonyms:** - Study procedures

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C209815Failure to Report or Delayed Reporting of an Adverse Event That Would Require Filing an Expedited Adverse Event (AE) Report

C209816Adverse Events Not Assessed by The Investigator in A Timely Manner (Per Protocol)

C209817Grades, Types, or Dates/Duration of Serious Adverse Events Inaccurately Recorded

C209820Recurrent Under- or Over-Reporting of Adverse Events

C209821Radiation Incorrect, Not Administered Correctly, or Not Adequately Documented

C209822Timing of Surgery Not Done Per Protocol or Surgery Not Adequately Documented

C209826Protocol-Directed Response Criteria Not Followed

C209852Follow Up Not Done Per Protocol

C209853Baseline (Non Eligibility Items)/Follow Up Visit Assessments are Out of Window

C209854Study-Related Activities Performed By Individual Not Assigned to Them on an Approved Delegation of Task Log

C225551Adverse Drug Reaction Reported Late

C225552Adverse Event Reported Late

C225553Study Assessment Incomplete

C225554Study Assessment Incorrectly Performed

C225555Study Assessment Not Performed

C225556Study Assessment Performed Outside of Timing Window

C225558Follow Up for Adverse Drug Reaction Reported Late

C225559Follow Up for Adverse Event Reported Late

C225560Follow Up for Pregnancy Reported Late

C225561Follow up for Serious Adverse Event Reported Late

C225571Pregnancy Reported Late

C225572Biological Sample Incorrectly Processed

C225573Serious Adverse Event Reported Late

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