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Table 4 Protocol violation reporting and protocol violation frequency.

From: Failure to report protocol violations in clinical trials: a threat to internal validity?

Protocol Violation Type Percent (number) of trials Proportion of Enrolled Participants with PVs
Median (range)
Calculated from trials with Explicit Reporting
Enrolment PVs   
   Explicit reporting 12.5% (10/80) 0.8% (1.6% to 9.1%)
   Incomplete reporting 8.8% (7/80)  
   Absent 78.8% (63/80)  
Randomisation PVs   
   Explicit reporting 8.8% (7/80) 0.7% (0.04% to 7.7%)
   Incomplete reporting 1.3% (1/80)  
   Absent 90.0% (72/80)  
Study Intervention PVs   
   Explicit reporting 21.2% (17/80) 1.3% (0% to 13.2%)
   Incomplete reporting 21.2% (17/80)  
   Absent 57.5% (46/80)  
Patient compliance PVs   
   Explicit reporting 47.5% (38/80) 7% (0.2% to 87%)
   Incomplete reporting 25.0% (20/80)  
   Absent 27.5% (22/80)  
Data Collection PVs   
   Explicit reporting 21.3% (17/80) 1.7% (0.0% to 16.1%)
   Incomplete reporting 18.8% (15/80)  
   Absent 60.0% (48/80)  
  1. Abbreviations: PV - protocol violations.