CCRC ACTUAL EXAM PAPER 2026
QUESTIONS WITH SOLUTIONS GRADED A+
◉ Blinding. Answer: A procedure in which one or more parties to the
trial are kept unaware of the treatment assignments.
◉ Single Blind. Answer: Refers to the subject being unaware of the
treatment assignment
◉ Double Blind. Answer: Refers to the subject, investigator, monitor,
and sometimes analyst being unaware of the treatment.
◉ Case Report Form (CRF). 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. Answer: An investigational or marketed product, or a
placebo, used as reference in a clinical trial.
◉ Contract Research Organization. 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). 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. 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. Answer: A pharmaceutical form of an active
ingredient or placebo being tested or used as reference in a clinical trial
◉ Investigator's Brochure. 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. Answer: A document that describes the objective(s), design,
methodology, statistical considerations, and organization of a trial.
◉ Serious Adverse Event (SAE). 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. 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. 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). Answer: Detailed, written
instructions to achieve uniformity of the performance of a specific
function.
◉ The purpose of an IRB is to: Answer: Protect the rights and welfare of
human subjects of research.
◉ The investigator must obtain IRB approval of the study and the
consent form: Answer: Before enrolling any patients in the study
QUESTIONS WITH SOLUTIONS GRADED A+
◉ Blinding. Answer: A procedure in which one or more parties to the
trial are kept unaware of the treatment assignments.
◉ Single Blind. Answer: Refers to the subject being unaware of the
treatment assignment
◉ Double Blind. Answer: Refers to the subject, investigator, monitor,
and sometimes analyst being unaware of the treatment.
◉ Case Report Form (CRF). 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. Answer: An investigational or marketed product, or a
placebo, used as reference in a clinical trial.
◉ Contract Research Organization. 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). 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. 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. Answer: A pharmaceutical form of an active
ingredient or placebo being tested or used as reference in a clinical trial
◉ Investigator's Brochure. 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. Answer: A document that describes the objective(s), design,
methodology, statistical considerations, and organization of a trial.
◉ Serious Adverse Event (SAE). 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. 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. 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). Answer: Detailed, written
instructions to achieve uniformity of the performance of a specific
function.
◉ The purpose of an IRB is to: Answer: Protect the rights and welfare of
human subjects of research.
◉ The investigator must obtain IRB approval of the study and the
consent form: Answer: Before enrolling any patients in the study
