Good Clinical Practice Quizzes- SET 1 questions with
correct answers
Any 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 records 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, whether 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
correct answers
Any 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 records 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, whether 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
