K
C
LO
YC
GOOD CLINICAL PRACTICE
D
EXAM SET 1 QUESTIONS AND
U
CORRECT VERIFIED
ST
ANSWERS 100% GUARANTEED
PASS A+ GRADE
, 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
K
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
C
significant disability/incapacity, or is a congenital anomaly/birth defect.
a. serious adverse event
LO
b. adverse drug reaction
c. unexpected adverse drug reaction
d. adverse event
a. serious adverse event
YC
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
D
b. clinical study report
c. informed consent form
d. audit report
U
e. source data
e. source data
ST
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
C
LO
YC
GOOD CLINICAL PRACTICE
D
EXAM SET 1 QUESTIONS AND
U
CORRECT VERIFIED
ST
ANSWERS 100% GUARANTEED
PASS A+ GRADE
, 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
K
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
C
significant disability/incapacity, or is a congenital anomaly/birth defect.
a. serious adverse event
LO
b. adverse drug reaction
c. unexpected adverse drug reaction
d. adverse event
a. serious adverse event
YC
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
D
b. clinical study report
c. informed consent form
d. audit report
U
e. source data
e. source data
ST
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
