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  • 28 september 2024
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  • 2024/2025
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ACRP-CP Certification Exam

Study online at https://quizlet.com/_f2sj4h



ACRP-CP CERTIFICATION EXAM TEST BANK. LATEST
2024-2025
1. What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial?: Try to obtain the subject's reason for
withdrawal.
2. CRO recently switched from paper CRF to an EDC system. The EDC system
must conform to the established requirements for: Validation
Accuracy
Reliability
Completeness
3. Part of a sponsor's responsibility pertaining to electronic trial data handling is to:
maintain an audit trail, data trail, and edit trail.
4. A research subject's responsibilities for study participation should be described
in the: ICF
5. What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP?: Investigators
brochure
6. During a multi site clinical study: whose responsibility is it to report subject
recruitment rate?: The CRA
7. 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: Obtain consent from
the subject for the study
8. 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...: A signed
clinical trial agreement between the site and sponsor is in place.
9. 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?: A research assistant who is certified to administer the
psychometric test
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?: Wording indicating that there is no expected benefit should be included
11. 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




, ACRP-CP Certification Exam

Study online at https://quizlet.com/_f2sj4h

the signatures of the investigator and sponsor. What should the CRA do FIRST?:
Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates.
12. 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?: PI
13. Which of the following required elements should be included in a clinical trial
protocol?: Subject inclusion and exclusion criteria
14. Prior to archiving a study: documentation of IP destruction at the site should
be filed in the study files of the: PI and Sponsor
15. During a monitoring visit: what records would a CRA reference to verify a
subject's compliance to the study visit schedule and assessments?: Electronic medical
record
16. When considering participation in a study: the investigator should determine
if he...: Sees enough patients who would qualify for the study
17. New safety information has become available from the Sponsor about the IP
being used in a clinical trial. The investigator must: Submit a revised ICF to the IRB
noting the new safety information
18. Per ICH: an IRB must keep correspondence for at least how long after the
completion of a clinical trial?: 3 Years
19. When would an impartial witness be needed during the consent process for an
illiterate subject?: To observe the consent process
20. A study which seeks to determine the ideal dose and regimen of a new IP to
treat hypothyroidism is considered to be: Phase II
21. 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?:
The sponsors files
22. 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?: ICF
23. When should a research study involving human subjects be registered in a
publicly accessible database?: Before recruiting the first subject
24. In the case of an incapacitated subject: who should receive a copy of the
signed and dated ICF?: The subjects legally acceptable representative
25. 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?: Consenting in the presence of figure of authority
26. The clinical trial phase that focuses on safety and human pharmacology in
healthy volunteers: Phase I






, ACRP-CP Certification Exam

Study online at https://quizlet.com/_f2sj4h

27. Who is ultimately responsible for all aspects of the research conducted at a
site?: Principal investigator
28. An international quality standard that is provided by ICH E6(R2) describing
safety: accuracy of trials and credibility of data: GCP
29. What event resulted in the Nuremburg Cod of 1949: Nazi Medical Experiments
30. In the case of an incapacitated subject: who should receive a copy of the
signed and dated ICF?: The subject's legally acceptable representative
31. Which of the following required elements should be included in a clinical trial
protocol?: The subject inclusion and exclusion criteria
32. During a multi-site clinical study: whose responsibility is it to report subject
recruitment rate?: The CRA
33. What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP?: IB
34. When considering participation in a study: the investigator should determine
if he/she: sees enough patients who would qualify for the study
35. During a monitoring visit: what records would a CRA reference to verify a
subject's compliance to the study visit schedule and assessments?: electronic medical
record
36. 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?: A research assistant who is certified to administer the psychometric test
37. . 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?: Wording indicating that there is no expected benefit should be included.
38. New safety information has become available from the Sponsor about the IP
being used in a clinical trial. The Investigator must: submit a revised ICF to the
IRB/IEC noting the new safety information.
39. 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?: Consenting in the presence of figure of
authority
40. Per ICH: an IRB/IEC must keep correspondence for at least how long after
the completion of a clinical trial?: 3 years
41. 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

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