ACRP-CP Certification Exam Study Guide Questions and Answers 2024
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ACRP-CP Certification
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ACRP-CP Certification
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.
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements...
ACRP-CP Certification Exam Study
Guide Questions and Answers 2024
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.
CRO recently switched from paper CRF to an EDC system. The EDC system must
conform to the established requirements for -Correct Answer ✔Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to -Correct
Answer ✔maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the -
Correct Answer ✔ICF
What document would an investigator reference to learn more about the previous
clinical and nonclinical results of studies of the IP? -Correct Answer ✔Investigators
brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment
rate? -Correct Answer ✔The CRA
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 -Correct Answer ✔Obtain consent from the subject for the
study
A site is in the start up phase of an industry sponsored phase 3 trial: and has received
IRB approval. The site can begin enrolling subjects after... -Correct Answer ✔A 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? -Correct Answer ✔A
research assistant who is certified to administer the psychometric test
ACRP-CP Certification Exam
,ACRP-CP Certification Exam
A research study: in which there is no intended clinical benefit to the subject: is being
submitted to the IRB. What benefit information should be included in the ICF? -Correct
Answer ✔Wording indicating that there is no expected benefit should be included
A CRA notices during an onsite visit that the date on IRB 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 submission dates.
In a multi arm: randomized clinical trial: one arm of the protocol was terminated due to
an increased risk of cancer in subjects. Who is responsible for providing a written report
to the IRB? -Correct Answer ✔PI
Which of the following required elements should be included in a clinical trial protocol? -
Correct Answer ✔Subject inclusion and exclusion criteria
Prior to archiving a study: documentation of IP destruction at the site should be filed in
the study files of the -Correct Answer ✔PI and Sponsor
During a monitoring visit: what records would a CRA reference to verify a subject's
compliance to the study visit schedule and assessments? -Correct Answer ✔Electronic
medical record
When considering participation in a study: the investigator should determine if he... -
Correct Answer ✔Sees enough patients who would qualify for the study
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 noting the new safety information
Per ICH: an IRB must keep correspondence for at least how long after the completion of
a clinical trial? -Correct Answer ✔3 Years
When would an impartial witness be needed during the consent process for an illiterate
subject? -Correct Answer ✔To observe the consent process
A study which seeks to determine the ideal dose and regimen of a new IP to treat
hypothyroidism is considered to be -Correct Answer ✔Phase II
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? -Correct Answer ✔The
sponsors files
ACRP-CP Certification Exam
, ACRP-CP Certification Exam
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
When should a research study involving human subjects be registered in a publicly
accessible database? -Correct Answer ✔Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed and
dated ICF? -Correct Answer ✔The subjects legally acceptable representative
A medical student is approaches by a faculty member for possible participation in a
cricothyroidotomy simulation research study. Which of the following increases risk to the
study? -Correct Answer ✔Consenting in the presence of figure of authority
The clinical trial phase that focuses on safety and human pharmacology in healthy
volunteers -Correct Answer ✔Phase I
Who is ultimately responsible for all aspects of the research conducted at a site? -
Correct Answer ✔Principal investigator
An international quality standard that is provided by ICH E6(R2) describing safety:
accuracy of trials and credibility of data -Correct Answer ✔GCP
What event resulted in the Nuremburg Cod of 1949 -Correct Answer ✔Nazi Medical
Experiments
Prior to archiving a study: documentation of IP destruction at the site should be filed in
the study files of the -Correct Answer ✔PI and Sponsor
In the case of an incapacitated subject: who should receive a copy of the signed and
dated ICF? -Correct Answer ✔The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol? -
Correct Answer ✔The subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it to report subject recruitment
rate? -Correct Answer ✔The CRA
A study which seeks to determine the ideal dose and regimen of a new IP to treat
hypothyroidism is considered to be -Correct Answer ✔Phase II
What document would an investigator reference to learn more about the previous
clinical and nonclinical results of studies of the IP? -Correct Answer ✔IB
ACRP-CP Certification Exam
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