ACRP-CP Certification Exam
1. What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial <Ans> 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 de- scribed
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 <Ans> Investigators
brochure
6. During a multi site clinical study: whose responsibility is it to report subject
recruitment rate <Ans> The CRA
7. An unconscious adult subject was enrolled in a study after obtaining con- sent
from an LAR: and protocol therapy was initiated.The subject showed sig- nificant
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 psycho- metric
test: a research specific tool which measures cognitive ability.Which of the following
individuals can administer the psychometric test to the potential subjects <Ans> 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
<Ans> 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 <Ans>
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 <Ans> PI
13. Which of the following required elements should be included in a clinical trial
protocol <Ans> 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 <Ans> Electronic
medical record
16. When considering participation in a study: the investigator should deter- mine 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 <Ans> 3 Years
19. When would an impartial witness be needed during the consent process for an
illiterate subject <Ans> 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
<Ans> 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 informa- tion of the
procedures and any foreseeable risks or inconveniences <Ans> ICF
23. When should a research study involving human subjects be registered in a
publicly accessible database <Ans> Before recruiting the first subject
24. In the case of an incapacitated subject: who should receive a copy of the signed
and dated ICF <Ans> The subjects legally acceptable representative
25. A medical student is approaches by a faculty member for possible par-
ticipation in a cricothyroidotomy simulation research study. Which of the following
increases risk to the study <Ans> 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
27. Who is ultimately responsible for all aspects of the research conducted at a site
<Ans> Principal investigator
1. What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial <Ans> 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 de- scribed
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 <Ans> Investigators
brochure
6. During a multi site clinical study: whose responsibility is it to report subject
recruitment rate <Ans> The CRA
7. An unconscious adult subject was enrolled in a study after obtaining con- sent
from an LAR: and protocol therapy was initiated.The subject showed sig- nificant
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 psycho- metric
test: a research specific tool which measures cognitive ability.Which of the following
individuals can administer the psychometric test to the potential subjects <Ans> 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
<Ans> 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 <Ans>
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 <Ans> PI
13. Which of the following required elements should be included in a clinical trial
protocol <Ans> 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 <Ans> Electronic
medical record
16. When considering participation in a study: the investigator should deter- mine 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 <Ans> 3 Years
19. When would an impartial witness be needed during the consent process for an
illiterate subject <Ans> 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
<Ans> 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 informa- tion of the
procedures and any foreseeable risks or inconveniences <Ans> ICF
23. When should a research study involving human subjects be registered in a
publicly accessible database <Ans> Before recruiting the first subject
24. In the case of an incapacitated subject: who should receive a copy of the signed
and dated ICF <Ans> The subjects legally acceptable representative
25. A medical student is approaches by a faculty member for possible par-
ticipation in a cricothyroidotomy simulation research study. Which of the following
increases risk to the study <Ans> 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
27. Who is ultimately responsible for all aspects of the research conducted at a site
<Ans> Principal investigator
