The Research Protocol (GCP) Questions & Answers.

The Research Protocol (GCP) Questions & Answers. A. Before the research study can begin. The research protocol must be approved by a designated Institutional Review Board: A. Before the research study can begin. B. After the first participant is randomized. C. By the last participant has completed the last follow up visit. D. There is no designated time for approval. C. Reduce the study sample size in order to minimize future protocol violations. Which of the following is NOT an appropriate response to a protocol violation occurrence: A. Document the violation and corrective action. B. Report the violation to the affiliated IRB. C. Reduce the study sample size in order to minimize future protocol violations. D. Immediately address any concerns regarding participant safety related to the violation. D. Procedures for accounting for missing, unused, and false data. Which of the following would you NOT expect to find in the Treatment of Subjects section of the research protocol? A. The names of all medications to be administered. B. The dosing schedules of all medications to be administered. C. Procedures for assessing treatment adherence. D. Procedures for accounting for missing, unused, and false data. B. Selection and Withdrawal of Participants Which section of the research protocol should describe the type and timing of data to be collected for participants who withdraw from the study? A. Data Management B. Selection and Withdrawal of Participants C. Assessment of Safety D. Background Information