ACRP CP CERTIFICATION EXAM 2025 |
QUESTIONS AND CORRECT ANSWERS
| GRADED A+ | VERIFIED ANSWERS |
LATEST VERSION (STUDY THIS ONE!)
If sponsor's attempts to secure compliance have failed: and the
monitoring/auditing identifies serious and/or persistent noncompliance on
the part of an investigator/institution: the sponsor should ---------CORRECT
ANSWER-----------------1. Promptly notify the regulatory authority(ies)
2. Terminate the investigator's/institution's participation in the trial
Essential documents should be retained at least ______ after the last
approval of a marketing application: or formal discontinuation of clinical
development of the investigational product. ---------CORRECT ANSWER----
-------------2 years
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--
---------------1. The sponsor should appoint individuals: who are independent
of the clinical trials/systems
2. 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
New safety information has become available from the Sponsor about the
IP being used in a clinical trial. The Investigator must ---------CORRECT
, ANSWER-----------------submit a revised ICF to the IRB/IEC noting the new
safety information.
A medical student is approached by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which of the
following increases risk to the subject? ---------CORRECT ANSWER----------
-------Consenting in the presence of figure of authority
What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial? ---------CORRECT ANSWER-------------
----Try to obtain the subject's reason for withdrawal.
A blood sample collection is required to screen for bloodborne pathogens
before subject could be enrolled in a study. Where will subjects find
information of the procedures and any foreseeable risks or
inconveniences? ---------CORRECT ANSWER-----------------ICF
Per ICH: an IRB/IEC must keep correspondence for at least how long after
the completion of a clinical trial? ---------CORRECT ANSWER-----------------3
years
A CRA notices during an onsite visit that the date on IRB/IEC approval
letter for a protocol is prior to the effective date indicated on the cover page
of the protocol and the signatures of the investigator and sponsor. What
should the CRA do FIRST? ---------CORRECT ANSWER-----------------
Confirm dates of initial receipt of the sponsor protocol and the IRB/IEC
submission dates.
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