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CCRC(questions well answered)graded A+
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CCRC(questions well answered)graded A+
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CCRCAdverse Drug Reaction - correct answer ✔✔All noxious and unintended responses to a medicinal
product related to any dose should be considered an ADR.
Blinding - correct answer ✔✔A procedure in which one or more parties to the trial are kept unaware of
the treatment assignments.
Single Blind - correct answer ✔✔Refers to the subject being unaware of the treatment assignment
Double Blind - correct answer ✔✔Refers to the subject, investigator, monitor, and sometimes analyst
being unaware of the treatment.
Case Report Form (CRF) - correct answer ✔✔A printed, optical, or electronic document designed to
record all of the protocol required information to be reported to the sponsor on each trial subject.
Comparator - correct answer ✔✔An investigational or marketed product, or a placebo, used as reference
in a clinical trial.
Contract Research Organization - correct answer ✔✔A person or organization contracted by the sponsor
to preform one or more of a sponsor's trial-related duties and functions.
Good Clinical Practice (GCP) - correct answer ✔✔A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the
data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of
the trial subjects are protected.
Institutional Review Board - correct answer ✔✔An independent body constituted of medical, scientific,
and non-scientific members, whose responsibility is to ensure the protection of the rights, safety, and
well-being of human subjects involved in the trial.
, Investigational Product - correct answer ✔✔A pharmaceutical form of an active ingredient or placebo
being tested or used as reference in a clinical trial
Investigator's Brochure - correct answer ✔✔A compilation of the clinical and non-clinical data on the
investigational product(s) which is relevant to the study of the investigational product(s) in human
subjects.
Protocol - correct answer ✔✔A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
Serious Adverse Event (SAE) - correct answer ✔✔Any untoward medical occurrence that at any dose:
-results in death,
-is life-threatening,
-requires inpatient hospitalization or prolongation
-results in persistent or significant disability/incapacity
Source data - correct answer ✔✔All information in original records and certified copies of original
records of clinical findings, observations, or other activities in a trial necessary for the reconstruction and
evaluation of the trial.
Sponsor - correct answer ✔✔An individual, company, institution, or organization which takes
responsibility for the initiation, management, and/or financing of a clinical trial.
Standard Operating Procedures (SOPs) - correct answer ✔✔Detailed, written instructions to achieve
uniformity of the performance of a specific function.
The purpose of an IRB is to: - correct answer ✔✔Protect the rights and welfare of human subjects of
research.
The investigator must obtain IRB approval of the study and the consent form: - correct answer
✔✔Before enrolling any patients in the study
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