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Data Collection Procedures

  • Adjudication committee members non-availability (General TA)
  • High Number of Sites with Local Lab References Ranges Delay
  • High Percentage of Image interpretation issues (Differences)
  • High Percentage of Image interpretation issues (Quality)
  • High Percentage of Manual Queries
  • High Percentage of Medical Device interface performance Issues
  • High Percentage of Missing eCRF Entries
  • High Percentage of Missing Forms (Pages)
  • High Percentage of Missing Visits
  • High Percentage of Overdue Monitoring eCRF Pages
  • High Percentage of Subjects with PDs in the Informed Consent Form
  • High Percentage of Total Overdue Queries
  • High Percentage of Tumor Data Issues
  • High Percentage of Unverified Queries
  • High Rate of Automated Queries
  • Long Mean Time for Data Entry
  • Long Mean Time for Response to Queries

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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