Good Clinical Practice Quizzes- SET
1 with Correct Answers 100% PASS
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.
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
, 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
1 with Correct Answers 100% PASS
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.
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
, 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
