GOOD CLINICAL PRACTICE QUIZZES-
SET 1 100% SOLVED QUESTIONS AND
ANSWERS
e 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 - 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 - 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 - 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 - 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 - 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 - a. trial subjects
Any untoward medical occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
a. adverse drug reaction
SET 1 100% SOLVED QUESTIONS AND
ANSWERS
e 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 - 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 - 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 - 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 - 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 - 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 - a. trial subjects
Any untoward medical occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
a. adverse drug reaction
