GOOD CLINICAL PRACTICE QUIZZES- SET 1 {
VERIFIED ANSWERS} 2025 LATEST UPDATE
1. Any individual member of the clinical trial team desig- b. sub-investigator
nated 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
2. Any untoward medical occurrence that at any dose e. source data
results in death, is life-threatening, requires inpatient
hospitalization or prolongation of existing hospitaliza-
tion, results in persistent or significant disability/inca-
pacity, or is a congenital anomaly/birth defect.
a. serious adverse event
b. adverse drug reaction
c. unexpected adverse drug reaction
d. adverse event
3. 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 re-
construction and evaluation of the trial.
a. protocol
b. clinical study report
c. informed consent form
d. audit report
,GOOD CLINICAL PRACTICE QUIZZES- SET 1 {
VERIFIED ANSWERS} 2025 LATEST UPDATE
a. serious adverse event
e. source data
, GOOD CLINICAL PRACTICE QUIZZES- SET 1 {
VERIFIED ANSWERS} 2025 LATEST UPDATE
4. Individuals whose willingness to volunteer in a clini- e. vulnerable
cal trial may be unduly influenced by the expectation, subjects
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 partici-
pate.
a. sub-investigators
b. coordinating investigators
c. impartial witnesses
d. vulnerable subjects
e. investigators
f. trial subjects
5. 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
6. Individuals who participate in a clinical trial, either as
recipients of the investigational product(s) or as con-
trols
a. trial subjects
b. principal investigators
c. coordinating investigators
d. sub-investigators
VERIFIED ANSWERS} 2025 LATEST UPDATE
1. Any individual member of the clinical trial team desig- b. sub-investigator
nated 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
2. Any untoward medical occurrence that at any dose e. source data
results in death, is life-threatening, requires inpatient
hospitalization or prolongation of existing hospitaliza-
tion, results in persistent or significant disability/inca-
pacity, or is a congenital anomaly/birth defect.
a. serious adverse event
b. adverse drug reaction
c. unexpected adverse drug reaction
d. adverse event
3. 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 re-
construction and evaluation of the trial.
a. protocol
b. clinical study report
c. informed consent form
d. audit report
,GOOD CLINICAL PRACTICE QUIZZES- SET 1 {
VERIFIED ANSWERS} 2025 LATEST UPDATE
a. serious adverse event
e. source data
, GOOD CLINICAL PRACTICE QUIZZES- SET 1 {
VERIFIED ANSWERS} 2025 LATEST UPDATE
4. Individuals whose willingness to volunteer in a clini- e. vulnerable
cal trial may be unduly influenced by the expectation, subjects
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 partici-
pate.
a. sub-investigators
b. coordinating investigators
c. impartial witnesses
d. vulnerable subjects
e. investigators
f. trial subjects
5. 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
6. Individuals who participate in a clinical trial, either as
recipients of the investigational product(s) or as con-
trols
a. trial subjects
b. principal investigators
c. coordinating investigators
d. sub-investigators
