Crossword Puzzle for CDS

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Across
  1. 2. Integrated addendum to ICH E6 GCP emphasizing risk-based quality management. (7)
  2. 4. Plan for pharmacovigilance and risk minimization. (3)
  3. 7. Attributes essential for reliable, interpretable results. (3)
  4. 8. Remote oversight of accumulating trial data as part of risk-based monitoring. (17)
  5. 9. Factors Critical-to-Quality(3)
  6. 10. Any departure from the approved clinical trial protocol. (17)
Down
  1. 1. FDA regulation for trustworthy electronic records and signatures. (11)
  2. 3. Medical Dictionary for Regulatory Activities (standardized terminology). (6)
  3. 5. Actions to reduce likelihood and/or impact of trial risks. (10)
  4. 6. CDISC Study Data Tabulation Model for regulatory submissions. (4)