Clinical Research Terminology

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Across
  1. 5. software used to electronically collect, manage, and store clinical research trial data
  2. 7. product a substance that has been tested in a lab and approved for testing in people
  3. 8. amendments written description of changes to a protocol
  4. 9. a procedure in which one or more parties to the trial are made aware of the treatment assignments
  5. 11. the process of assigning clinical trial participants to treatment or control groups
  6. 14. deviations failure to conduct a study as described in the protocol
  7. 15. an inactive pill, liquid, powder, or other intervention that has no treatment value
  8. 18. trials to test a new biomedical intervention in a small group of people for the first time
  9. 20. ensures each trial site is operating according to protocol
  10. 21. helps clinical trial sponsors and sites manage patient and drug supply logistics
Down
  1. 1. ii trials to study the bio medical or behavioral intervention in a larger group of people to further evaluate safety
  2. 2. log a log of study drugs kept by an investigator running a clinical trial
  3. 3. document describing the objectives and design of a trial
  4. 4. iii studies to investigate the efficacy of biomedical or behavioral intervention to other standard or experimental interventions
  5. 6. a person, company, institution, group or other organization that oversees or pays for a clinical trial and collects and analyzes the data
  6. 10. Consent process by which a participant or legal guardian voluntarily confirms willingness to participate in a clinical trial
  7. 12. An individual that handles the administrative and day to day responsibilities of a clinical trial
  8. 13. detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site
  9. 14. iv studies conducted after the intervention has been marketed
  10. 16. an organization that offers clinicla trial and related services for pharmaceutical drug development
  11. 17. Clinical Practice A standard for the design, conduct, performance, monitoring, auditing and reporting of clinical trials
  12. 19. an independent body responsible for ensuring the protection of the rights, safety, and well being of human subjects in research