CCRP SOCRA Actual preparation test exam with Thorough and Correct Answers Updated 2024/2025
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CCRP SOCRA
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CCRP SOCRA
CCRP SOCRA Actual preparation test exam with Thorough and Correct Answers Updated 2024/2025
What is the purpose of the IRB/IEC? - correct answer Safeguard the rights, safety, and well-being of all trial subjects
Which of the following should the investigator do FIRST if a Serious Adverse Even...
CCRP SOCRA Actual preparation test exam
with Thorough and Correct Answers Updated
2024/2025
What is the purpose of the IRB/IEC? - correct answer Safeguard
the rights, safety, and well-being of all trial subjects
Which of the following should the investigator do FIRST if a
Serious Adverse Event (SAE) occurs? - correct answer Inform
the Sponsor per protocol and regulatory requirements
According to ICH E6 Who must sign the Informed Consent Form
(ICF)? - correct answer 1. The person who conducted the
informed consent interview
2. The subject or the subject's legal representative
A non-English speaking subject has responded to a recruitment
ad to participate in a trial for treatment of her diabetes. She
arrives at the site with her daughter who is fluent in English. The
informed consent forms are only available in English. What
actions are compliant with GCP? - correct answer Call the
sponsor to request a translation of the informed consent
Per ICH GCP E6, the purpose/elements of trial monitoring differ
from trial auditing. Which apply to trial auditing ONLY? - correct
answer -The sponsor should appoint individuals, who are
independent of the clinical trials/systems
-Regulatory authority(ies) should not routinely request this type
of reports, (they may seek access to reports on a case by case
,basis when evidence of serious GCP non-compliance exists, or in
the course of legal proceedings)
As per ICH E6 GCP, which groups of potential subjects could be
defined as "vulnerable subjects?" - correct answer 1. Members
of the armed forces
2. Junior members of the medical profession
3. Employees of the pharmaceutical industry
Which phase determines therapeutic benefit, usually in wider
populations? - correct answer Phase 3
What phase of a clinical trial involves a heavy emphasis on safety
and tolerability, Pharmacokinetics, Pharmacodynamics and early
measurement of drug activity? - correct answer Phase 1
The principles and practices concerning protection of trial
subjects are stated in the ICH Guideline on Good Clinical
Practice (ICH E6). These principles have their origins from: -
correct answer Declaration of Helsinki
The main goal of this phase of drug development is to explore
therapeutic efficacy in patients. It is important during this phase
to determine the dose(s) and regimens that will be used for later
trials. - correct answer 1. Selection of the initial human dose
2. Safe duration of drug exposure
3. Physiological and toxicological effects of a new drug
, T or F: The intention of ICH E8 is to describe internationally
accepted principles and practices in the conduct of both
individual clinical trials and overall development strategy for
new medicinal products. - correct answer True
Dose-tolerance studies, single and multiple dose PK and/or PD
studies, and drug interaction studies are examples of what phase
of clinical research? - correct answer Phase One
Characterization of a drug's absorption, distribution, metabolism,
and excretion that continues throughout the development plan is
defined as: - correct answer Pharmacokinetics
According to ICH E8, "Formulations used in clinical trials should
be well characterized, including information on ___________
whenever feasible." - correct answer Bioavailability
The study subject asks you why the study is called a double blind
study. You will explain double blind as: - correct answer When
the Investigator and sponsor staff who are involved in the
treatment or clinical evaluation of the subjects and analysis of
data are unaware of the treatment assignments
According to ICH E8 what type of study would have the following
elements?Adequate, and well controlled studies to establish
efficacy:
-Randomized parallel dose response studies
-Clinical safety studies
-Studies of mortality/morbidity outcomes
-Large simple trials - correct answer Therapeutic Confirmatory
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