GCP

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Across
  1. 5. GCP helps protect __________by ensuring a high level of quality for each trial that is conducted.
  2. 7. Who is responsible for planning and driving DORA meetings?
  3. 8. Items identified and discussed in the IQMP
  4. 9. Inquiries made to the investigative sites, laboratories, and other non-sponsor organizations for the purposes of data clarification or cleaning
  5. 11. software that validates data quality and compliance with CDISC standards
  6. 13. 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. 4. Design ICH GCP states the scientific integrity of the trial and the credibility of the data from the trial depend substantially on the ______.
  5. 6. What R stands for in the DRP
  6. 10. Amendments to the approved SAP cannot be made after final _______ Creation
  7. 11. After ___________ is approved, SAP can be Finalized
  8. 12. Team responsible for non-CRF data reconciliation