General Therapeutic Area
- High Percentage of Screen Failures
- High Percentage of Start-Up Delays
- High Percentage of Subject Death
- High Percentage of Subjects who can't switch from one formulation to another formulation
- High Percentage of Subjects with PDs in the Informed Consent Form
- High Percentage of Subjects with PDs related to in/exclusion criteria (kri)
- High Percentage of Subjects with poor quality ECGs
- High Percentage of Total Overdue Queries
- High Percentage of Treatment Interruption
- High Percentage of Unblinding cases
- High Percentage of Unverified Queries
- High Rate of Automated Queries
- High Rate of overall PDs (kri)
- Inappropriate IP administration (dose/timing dispensing error)
- Long Mean Time for Data Entry
- Long Mean Time for Response to Queries
- Overrecruitment
- Overreporting of Reported (S)AEs
- Underrecruitment
- Underreporting of Reported (S)AEs