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Good Clinical Practice Quizzes- SET 1 Answered 2023
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Good Clinical Practice Quizzes- SET 1 Answered 2023
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Good Clinical Practice Quizzes- SET 1 Answered 2023Any 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 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 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 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 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 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 Answer - 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
b. serious adverse event
c. unexpected adverse drug reaction
d. adverse event Answer - d. adverse event
A document that describes the objective, design, methodology, statistical considerations, and organization of a trial and usually also gives the background and
rationale for the trial.
a. clinical study report
b. informed consent form
c. essential document
d. protocol
e. audit report Answer - d. protocol
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provide assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality or that subjects are protected.
a. good manufacturing practice
b. good clinical practice
c. good laboratory practice
d. good pharmacovigilance practice Answer - b. good clinical practice
A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who
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