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ACRP CP FINAL EXAM LATEST VERSION ACTUAL 150 QUESTION AND CORRECT ANSWERS AGRADE.
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ACRP CP FINAL EXAM LATEST VERSION ACTUAL 150 QUESTION AND CORRECT ANSWERS AGRADE.
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ACRP CP FINAL EXAM LATEST VERSION ACTUAL150 QUESTION AND CORRECT ANSWERS|AGRADE.
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? - ansICF
A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject
as the subject was suffering from Adverse Events (AEs) like headaches and vomiting. When is a CRC
allowed to do this task? - ansOnly when the CRC is a qualified physician and has been delegated this
responsibility by the PI
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? - ansConfirm dates of initial receipt of the sponsor protocol
and the IRB/IEC submission dates.
A CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the
established requirements for: - ansvalidation, accuracy, reliability, and completeness.
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? - ansConsenting in the
presence of figure of authority
A new study is investigating a new IND "glue" that can be used to hold skin cuts together and decrease
the chance of scaring. You know children should be included because ICH E8 considers them a special
population. In designing the protocol you should expect to: - ansInclude children in the general plan from
the beginning
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? - ansCall the sponsor to
request a translation of the informed consent
A research study, in which there is no intended clinical benefit to the subject, is being submitted to the
IRB/IEC. What benefit information should be included in the ICF? - ansWording indicating that there is no
expected benefit should be included.
A research subject's responsibilities for study participation should be described in the: - ansICF
A site is in the start-up phase of an industry-sponsored phase 3 trial, and has received IRB/IEC approval.
The site can begin enrolling subjects after: - ansa signed clinical trial agreement between the site and
sponsor is in place.
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion
criteria is a score of 25 or less on a psychometric test, a research-specific tool which measures cognitive
ability. Which of the following individuals can administer the psychometric test to the potential subjects? -
ansA research assistant who is certified to administer the psychometric test
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is
considered to be: - ansPhase II
A subject has a suspected serious adverse drug reaction with the outcome of death. Which are items that
should be submitted to the Sponsor? - ans1. A de-identified autopsy report, if available
2. Cause of death, and a comment on its possible relationship to the suspected drug reaction
,ACRP CP FINAL EXAM LATEST VERSION ACTUAL
150 QUESTION AND CORRECT ANSWERS|AGRADE.
A subject, who has been 100% compliant thus far has forgotten to bring her medication back to the clinic
for her regular visit. She reports that she has not missed any doses and has been fully compliant with the
protocol. What is the most appropriate action for the investigator/clinical research coordinator to take? -
ansDocument that the subject has forgotten to return her medication in the source document and ask her
to bring the medication back to the clinic as soon as possible or during her next visit
A trial where the treatment assignment is not known by the study participant because of the use of
placebo or other methods of masking the intervention, but the study team knows: - ansSingle blind
According to ICH E6 Who must sign the Informed Consent Form (ICF)? - ans1. The person who
conducted the informed consent interview
2. The subject or the subject's legal representative
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 - ansTherapeutic Confirmatory
According to ICH E8, "Formulations used in clinical trials should be well characterized, including
information on ___________ whenever feasible." - ansBioavailability
After a Serious Adverse Event (SAE) has occurred, how should you list the subject identification on the
immediate and follow-up reports? - ansBy their subject identification number
After completion of a study, the final trial close-out monitoring report prepared by the CRA should be filed
in which of the following stakeholder files? - ansThe sponsor's files
All cases judged by either the reporting health care professional or the sponsor as having a reasonable
suspected causal relationship to the medicinal product qualify as: - ansAdverse Drug Reactions
An Adverse Event (AE) that is severe in intensity - ansMay not meet the definition of serious
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and protocol
therapy was initiated. The subject showed significant improvement in his clinical condition, and regained
consciousness. The Investigator should inform the subject about the study and: - ansobtain consent from
the subject for the study.
An Unexpected Adverse drug reaction is: - ansA reaction that is not consistent with the applicable product
information
As per ICH E6 GCP, which groups of potential subjects could be defined as "vulnerable subjects?" - ans1.
Members of the armed forces
2. Junior members of the medical profession
3. Employees of the pharmaceutical industry
Characterization of a drug's absorption, distribution, metabolism, and excretion that continues throughout
the development plan is defined as: - ansPharmacokinetics
Data and Safety Monitoring Boards (DSMBs) have the power to recommend which of the following? -
ans-That the sponsor should continue the trial
-That the sponsor should modify the trial
-That the sponsor should stop the trial
,ACRP CP FINAL EXAM LATEST VERSION ACTUAL
150 QUESTION AND CORRECT ANSWERS|AGRADE.
Dose-tolerance studies, single and multiple dose PK and/or PD studies, and drug interaction studies are
examples of what phase of clinical research? - ansPhase One
Dosing recommendations for most medicinal products used in the pediatric population are usually based
on ________________ due to frequency of calculation errors. - ansMg/kg body weight
During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the
study visit schedule and assessments? - ansElectronic medical record
During a multi-site clinical study, whose responsibility is it to report subject recruitment rate? - ansThe
CRA
During clinical development, the timing of pediatric studies will depend on: - ans-Medicinal product
-Type of disease being treated
-Safety considerations
-Efficacy and safety of alternative treatments
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. - ans2 years
For a randomized trial, the following is true: - ans-The procedure to be followed, the necessary
documentation, and the subsequent treatment and assessment of the subject should all be described in
the protocol
-Helps to avoid possible bias in the selection and allocation of subjects arising from the predictability of
treatment assignments
How can an Adverse Drug Reaction (ADR) be defined? - ansAs a noxious and unintended response to
the investigational drug
ICH safety definitions can be found in - ansICH E2A
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: - ans1.
Promptly notify the regulatory authority(ies)
2. Terminate the investigator's/institution's participation in the trial
In a multi-arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk
of breast cancer in the subjects. Who is responsible for providing a written report to the IRB/IEC? - ansPI
In pre-market approval studies, all noxious and unintended responses to a medicinal product even
possibly related to any dose should be considered: - ansAdverse Drug Reaction
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ansThe
subject's legally acceptable representative
In which scenario would unblinding typically occur? - ansWhen the investigator wants to make sure a
particular subject is not randomized to placebo in the case of a Serious Adverse Event (SAE)
New safety information has become available from the Sponsor about the IP being used in a clinical trial.
The Investigator must: - anssubmit a revised ICF to the IRB/IEC noting the new safety information.
Non-compliance is a special problem in this age group. - ansAdolescents
, ACRP CP FINAL EXAM LATEST VERSION ACTUAL
150 QUESTION AND CORRECT ANSWERS|AGRADE.
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - ansmaintain an audit
trail, data trail, and edit trail.
Per ICH E8, methods used to evaluate patient usage of the test drug should be: - ansSpecified in the
protocol and actual usage documented
Per ICH GCP E6, the purpose/elements of trial monitoring differ from trial auditing. Which apply to trial
auditing ONLY? - ans-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)
Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a clinical
trial? - ans3 years
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of
the: - ansPI and Sponsor.
Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after
participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's Brochure as a
possible side effect. This is considered a/an: - ansSerious Adverse Drug Reaction
T or F: A subject in your diabetes research study developed colon cancer, which the Investigator has
determined to be unrelated to the study. The subject is currently asymptomatic. This will be considered a
serious adverse event because it is life threatening. - ansFalse
T or F: Although initial safety and tolerability data is usually obtained in adult trials, some products may
reasonably be studied only in the pediatric population even in the initial phases (e.g., when studies in
adults would yield little useful information or expose them to inappropriate risk). - ansTRUE
T or F: Information discovered during the course of a clinical investigation that might materially influence
the benefit-risk assessment of the investigation/product may necessitate rapid communication to
regulatory authorities. - ansTrue
T or F: It is common to extrapolate efficacy from studies in adults or even in older pediatric patients to the
preterm newborn infant to decrease the amount of blood taken. - ansFalse
T or F: Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy
pediatric subjects. - ansFalse
T or F: Pharmacokinetic studies in the pediatric population are generally conducted in patients with the
disease. - ansTrue
T or F: The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review
Board (IRB) or an Independent Ethics Committee (IEC)? - ansTrue
T or F: The focus of ICH E9 is on statistical principles, however, it does not address the use of specific
statistical procedures or methods. - ansTrue
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. -
ansTrue
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