Good Clinical Practice Quizzes- SET 1
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 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
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 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
