ACRP-CP CERTIFICATION EXAM
QUESTIONS AND ANSWERS
2024
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
10. 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 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
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