GCP - Part 3

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Across
  1. 1. The sponsor is required to designate qualified personnel to be available to advise on study related ________ questions. (two words)
  2. 4. Any correction to a CRF or other document should not _________ the original entry.
  3. 5. Type of criteria listed in the protocol which determines who can participate in the study.
  4. 6. A CV is an essential document to be filed in your regulatory binder because it documents ______ to conduct the trial and/or provide medical supervision.
  5. 7. The protocol should include a description of the route of __________, dosage, regimen, and treatment period for investigational product.
  6. 8. The sponsor updates the Investigator’s Brochure as ________ new info becomes available.
  7. 10. The investigator should ensure the accuracy of data reported in the ______.
  8. 11. If the sponsor collects study data electronically, they’re required to maintain a security system to prevent _________ access to the data.
  9. 12. The informed consent form should indicate that the IRB, monitor, and regulatory bodies will have access to the subject’s ________ to verify data and study procedures. (two words)
  10. 14. __________ and lab abnormalities identified as critical to safety evaluations in the protocol should be reported to the sponsor.
  11. 16. The monitor verifies that the receipt, use, and return of investigational product at the study site is adequately __________.+
  12. 18. SAE reports should identify participants by unique ________ numbers so their identify is protected.
Down
  1. 2. In order to assess safety, the protocol should specify the type and ______ of follow up of subjects after adverse events.
  2. 3. Documentation of communications with the sponsor such as letters, meeting notes, and notes of telephone calls are an essential document to be filed in your regulatory binder because they document any agreements or significant ____________ with the sponsor regarding study administration and conduct.
  3. 6. Sponsors may perform audits as part of implementing __________________. (two words)
  4. 9. One purpose of monitoring is to ensure that the data we report to the sponsor are complete, _________, and accurate.
  5. 13. Advertisements for subject recruitment are an essential document to be filed in your regulatory binder because it documents that recruitment is appropriate and not ________.
  6. 15. The protocol should include a statement of the primary _________ to be measured during the trial which are used to determine the effectiveness of the study treatment.
  7. 17. When planning trials, a sponsor should ensure there is sufficient safety and ________ data to support human exposure by the route, dosages, and duration specified.