3/27/26, 1:27 PM CCRC EXAM (2026) UPDATE Verified Questions And Answers | Latest Already Graded A+ UPDATE |2026 Flashcards | Quizlet
CCRC EXAM (2026) UPDATE Verified Questions
And Answers | Latest Already Graded A+ UPDATE
|2026
Save
Terms in this set (117)
Adverse Drug Reaction All noxious and unintended responses to a
medicinal product related to any dose should be
considered an ADR.
Blinding A procedure in which one or more parties to the
trial are kept unaware of the treatment
assignments.
Single Blind Refers to the subject being unaware of the
treatment assignment
Double Blind Refers to the subject, investigator, monitor, and
sometimes analyst being unaware of the treatment.
Case Report Form (CRF) 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.
https://quizlet.com/1161116369/ccrc-exam-2026-update-verified-questions-and-answers-latest-already-graded-a-update-2026-flash-cards/?new 1/16
,3/27/26, 1:27 PM CCRC EXAM (2026) UPDATE Verified Questions And Answers | Latest Already Graded A+ UPDATE |2026 Flashcards | Quizlet
Comparator An investigational or marketed product, or a
placebo, used as reference in a clinical trial.
Contract Research Organization 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) 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 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 A pharmaceutical form of an active ingredient or
placebo being tested or used as reference in a
clinical trial
Investigator's Brochure 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 A document that describes the objective(s), design,
methodology, statistical considerations, and
organization of a trial.
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, 3/27/26, 1:27 PM CCRC EXAM (2026) UPDATE Verified Questions And Answers | Latest Already Graded A+ UPDATE |2026 Flashcards | Quizlet
Serious Adverse Event (SAE) 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 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 An individual, company, institution, or organization
which takes responsibility for the initiation,
management, and/or financing of a clinical trial.
Standard Operating Procedures Detailed, written instructions to achieve uniformity
(SOPs) of the performance of a specific function.
The purpose of an IRB is to: Protect the rights and welfare of human subjects of
research.
The investigator must obtain IRB Before enrolling any patients in the study
approval of the study and the
consent form:
The IRB must inform the investigator Written notification saying it has been approved
the study has been approved by:
For initial approval of proposed The full protocol and the informed consent
research, the investigaot must submit
to the IRB:
https://quizlet.com/1161116369/ccrc-exam-2026-update-verified-questions-and-answers-latest-already-graded-a-update-2026-flash-cards/?new 3/16
CCRC EXAM (2026) UPDATE Verified Questions
And Answers | Latest Already Graded A+ UPDATE
|2026
Save
Terms in this set (117)
Adverse Drug Reaction All noxious and unintended responses to a
medicinal product related to any dose should be
considered an ADR.
Blinding A procedure in which one or more parties to the
trial are kept unaware of the treatment
assignments.
Single Blind Refers to the subject being unaware of the
treatment assignment
Double Blind Refers to the subject, investigator, monitor, and
sometimes analyst being unaware of the treatment.
Case Report Form (CRF) 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.
https://quizlet.com/1161116369/ccrc-exam-2026-update-verified-questions-and-answers-latest-already-graded-a-update-2026-flash-cards/?new 1/16
,3/27/26, 1:27 PM CCRC EXAM (2026) UPDATE Verified Questions And Answers | Latest Already Graded A+ UPDATE |2026 Flashcards | Quizlet
Comparator An investigational or marketed product, or a
placebo, used as reference in a clinical trial.
Contract Research Organization 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) 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 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 A pharmaceutical form of an active ingredient or
placebo being tested or used as reference in a
clinical trial
Investigator's Brochure 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 A document that describes the objective(s), design,
methodology, statistical considerations, and
organization of a trial.
https://quizlet.com/1161116369/ccrc-exam-2026-update-verified-questions-and-answers-latest-already-graded-a-update-2026-flash-cards/?new 2/16
, 3/27/26, 1:27 PM CCRC EXAM (2026) UPDATE Verified Questions And Answers | Latest Already Graded A+ UPDATE |2026 Flashcards | Quizlet
Serious Adverse Event (SAE) 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 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 An individual, company, institution, or organization
which takes responsibility for the initiation,
management, and/or financing of a clinical trial.
Standard Operating Procedures Detailed, written instructions to achieve uniformity
(SOPs) of the performance of a specific function.
The purpose of an IRB is to: Protect the rights and welfare of human subjects of
research.
The investigator must obtain IRB Before enrolling any patients in the study
approval of the study and the
consent form:
The IRB must inform the investigator Written notification saying it has been approved
the study has been approved by:
For initial approval of proposed The full protocol and the informed consent
research, the investigaot must submit
to the IRB:
https://quizlet.com/1161116369/ccrc-exam-2026-update-verified-questions-and-answers-latest-already-graded-a-update-2026-flash-cards/?new 3/16
