GCP

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Across
  1. 4. After ___________ is approved, SAP can be Finalized.
  2. 6. ICH GCP states the scientific integrity of the trial and the credibility of the data from the trial depend substantially on the ______.
  3. 7. GCP helps protect __________by ensuring a high level of quality for each trial that is conducted.
  4. 9. Amendments to the approved SAP cannot be made after final _______ Creation
  5. 10. Items identified and discussed in the IQMP
  6. 11. Inquiries made to the investigative sites, laboratories, and other non-sponsor organizations for the purposes of data clarification or cleaning
  7. 12. software that validates data quality and compliance with CDISC standards
  8. 14. In DMB - B stands for
Down
  1. 1. Platform commonly used in risk-based monitoring
  2. 2. A medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products
  3. 3. who is responsible for the generation of Randomization
  4. 5. Who is responsible for planning and driving DORA meetings?
  5. 8. What does R stand for in the DRP
  6. 13. Team responsible for non-CRF data reconciliation