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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
  • 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
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Categories

  • Blinding
  • Cardiovascular Therapeutic Area
  • Data Collection Procedures
  • Diabetes Therapeutic Area
  • General Therapeutic Area
  • Golden KRIs
  • IMP supply chain
  • Medical Device Therapeutic Area
  • Oncology Therapeutic Area
  • Operational Complexity
  • Organizational Experience
  • Safety
  • Strategic KRIs
  • Study Complexity
  • Study Endpoints
  • Subject Population
  • Technology
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