Good Clinical Practice Quizzes- Set 1 | Latest Version | 2024/2025 | Already Passed

Good Clinical Practice Quizzes- Set 1 | Latest Version | 2024/2025 | Already Passed Who is responsible for performing key trial-related tasks and making important decisions under the supervision of the principal investigator at a trial site? a. Principal investigator b. Sub-investigator c. Study coordinator d. Coordinating investigator b. Sub-investigator What term describes any adverse medical event that leads to death, poses a life-threatening risk, necessitates hospitalization or extends a current hospital stay, results in significant disability/incapacity, or causes a congenital anomaly/birth defect? a. Serious adverse event b. Adverse drug reaction c. Unexpected adverse drug reaction d. Adverse event a. Serious adverse event What encompasses all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for reconstructing and evaluating the trial? a. Protocol b. Clinical study report c. Informed consent form d. Audit report e. Source data e. Source data Who are the individuals at risk of being unduly influenced to participate in a clinical trial due to expectations of benefits or fear of retaliation from senior members of a hierarchy? a. Sub-investigators b. Coordinating investigators c. Impartial witnesses d. Vulnerable subjects e. Investigators f. Trial subjects d. Vulnerable subjects What are the documents called that individually and collectively allow for the evaluation of a study's conduct and the quality of the data it produces? a. Informed consent forms b. Monitoring reports c. Case report forms d. Audit certificates e. Essential documents e. Essential