Good Clinical Practice Quizzes- SET 1 correctly answered graded A+ 2023/2024

Good Clinical Practice Quizzes- SET 1Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigator c. study coordinator d. coordinating investigator - correct answer b. sub-investigator Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. a. serious adverse event b. adverse drug reaction c. unexpected adverse drug reaction d. adverse event - correct answer a. serious adverse event All information in original records and certified copies of original recors of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. a. protocol b. clinical study report c. informed consent form d. audit report e. source data - correct answer e. source data Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, wether justified or not, of benefits associated with participation or of a retaliatory response from senior members of a hierarchy in case or refusal to participate. a. sub-investigators b. coordinating investigators c. impartial witnesses d. vulnerable subjects e. investigators f. trial subjects - correct answer d. vulnerable subjects Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. a. informed consent forms b. monitoring reports c. case report forms d. audit certificates e. essential documents - correct answer e. Essential documents Individuals who participate in a clinical trial, either as recipients of the investigational product(s) or as controls a. trial subjects b. principal investigators c. coordinating investigators d. sub-investigators e. vulnerable subjects - correct answer a. trial subjects