ACRP-CP Exam
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1. In any trial, what should be the main concern of the physician?: The welfare
of the subjects
2. The world medical association (WMA) ethical principles for medical re-
search involving human subjects is called:: The Declaration of Helsinki
3. The process by which a subject voluntarily confirms his or her willingness
to participate in a clinical trial is known as:: Informed Consent of Trial Subjects
4. What does the IRB/IEC evaluate?: The scientific tenability of the trial, the
subject-selection procedure, and the rights, safety, and well being of the subjects
participating in the trial
5. Which of the following documents is the investigator obliged to comply
with during the trial?: All applicable laws and regulations, ICH-GCP, and the trial
protocol
6. What is the purpose of the initiation visit?: To review the protocol, to review
the blank case report forms (CRFs), and to review standard procedures
7. Who is ultimately responsible for Source Data Verification (SDV)?: The mon-
itor
8. Every research study involving human subjects must be registered in a
publicly accessible database before recruitment of the first subject (T/F).: True
9. The Declaration of Helsinki was developed by:: the WMA
10. This phase determines therapeutic benefit and is usually done in larger,
specific population:: Phase 3
11. Therapeutic use & begins after drug approval.: Phase 4
12. A sponsor can be defined as...: Phase 1
13. Providing a unified standard for Europe, US, and Japan to facilitate the
acceptance of clinical trials is the..: Mission statement of the ICH
14. A sub-investigator can be defined as..: Any individual member of the clinical
trial team designated and supervised by the investigator of a trial site to perform
clinical trial related procedures and/or to make important trial related decisions
15. According to the principles of ICH GCP...: 1. Clinical trials should be conduct-
ed in accordance with the ethical principles that have their origin in the DoH and that
are consistent with GCP and the applicable regulatory requirement(s)
2. Before a trial is initiated, foreseeable risks and inconveniences should be weighted
against the anticipated benefit for the individual trial subject and society. A trial
should be initiated and continued only if the anticipated benefits justify the risks.
3. The available nonclinical and clinical info on an investigational product should be
adequate to support the proposed clinical trial
4. Clinical trials should be scientifically sound, and described in a clear, detailed
protocol
, ACRP-CP Exam
Study online at https://quizlet.com/_eqj5o2
16. Source data are..: All info in original records and certified copies of original
records of critical findings, observations, or other activities in a clinical trial necessary
for the reconstruction and evaluation of the trial
17. What is the purpose of the IRB/IEC?: To protect subject safety
18. Who is responsible for providing the trial protocol?: The sponsor
19. What does DSMB stand for?: Data and Safety Monitoring Board
20. One of the primary purposes of a Phase 1 study is to:: Determine the
metabolic and pharmacologic action of the drug in humans
21. What is the purpose of the DSMB?: To assess the progress of a clinical trial,
the safety data, and the critical efficacy endpoints
22. An investigator can be defined as...: 1. A person responsible for writing the
trial protocol
2. A person responsible for the conduct of the clinical trial with the sponsor
3. A person responsible for the conduct of the clinical trial at the trial site.
23. A potential investigator usually only receives a protocol IB to review from
a sponsor:: After the signing of a confidentiality agreement
24. Which of the following is NOT one of the required elements of an informed
consent form?: A listing of all site personnel who will be involved in the research
25. Hoe should SAEs be reported?: To the sponsor immediately and to the
IRB/IEC if applicable
26. After a SAE has occurred, how should subject identification occur on the
immediate and f/u reports?: By their subject identification number
27. In the event of a subject's death, what additional info should be supplied
to the sponsor?: 1. An autopsy report, if available
2. Terminal medical reports, if available
28. What documentation should be supplied to the sponsor before the study?-
: 1. The signed contract between sponsor and investigator
2. The CVs of all investigators and other study personnel who are significantly
involved in trial related duties
29. Who must sign the ICF?: 1. The subject with the subject's legal representative
2. The person who conducted the informed consent interview
30. What details need to be documented in the subject notes when an AE
occurs?: 1. The severity of the event
2. When the event occurred
31. Who is responsible for the appropriate monitoring of clinical trials?: The
sponsor
32. During the trial, who is responsible for communicating with the IRB/IEC?-
: The investigator
Study online at https://quizlet.com/_eqj5o2
1. In any trial, what should be the main concern of the physician?: The welfare
of the subjects
2. The world medical association (WMA) ethical principles for medical re-
search involving human subjects is called:: The Declaration of Helsinki
3. The process by which a subject voluntarily confirms his or her willingness
to participate in a clinical trial is known as:: Informed Consent of Trial Subjects
4. What does the IRB/IEC evaluate?: The scientific tenability of the trial, the
subject-selection procedure, and the rights, safety, and well being of the subjects
participating in the trial
5. Which of the following documents is the investigator obliged to comply
with during the trial?: All applicable laws and regulations, ICH-GCP, and the trial
protocol
6. What is the purpose of the initiation visit?: To review the protocol, to review
the blank case report forms (CRFs), and to review standard procedures
7. Who is ultimately responsible for Source Data Verification (SDV)?: The mon-
itor
8. Every research study involving human subjects must be registered in a
publicly accessible database before recruitment of the first subject (T/F).: True
9. The Declaration of Helsinki was developed by:: the WMA
10. This phase determines therapeutic benefit and is usually done in larger,
specific population:: Phase 3
11. Therapeutic use & begins after drug approval.: Phase 4
12. A sponsor can be defined as...: Phase 1
13. Providing a unified standard for Europe, US, and Japan to facilitate the
acceptance of clinical trials is the..: Mission statement of the ICH
14. A sub-investigator can be defined as..: Any individual member of the clinical
trial team designated and supervised by the investigator of a trial site to perform
clinical trial related procedures and/or to make important trial related decisions
15. According to the principles of ICH GCP...: 1. Clinical trials should be conduct-
ed in accordance with the ethical principles that have their origin in the DoH and that
are consistent with GCP and the applicable regulatory requirement(s)
2. Before a trial is initiated, foreseeable risks and inconveniences should be weighted
against the anticipated benefit for the individual trial subject and society. A trial
should be initiated and continued only if the anticipated benefits justify the risks.
3. The available nonclinical and clinical info on an investigational product should be
adequate to support the proposed clinical trial
4. Clinical trials should be scientifically sound, and described in a clear, detailed
protocol
, ACRP-CP Exam
Study online at https://quizlet.com/_eqj5o2
16. Source data are..: All info in original records and certified copies of original
records of critical findings, observations, or other activities in a clinical trial necessary
for the reconstruction and evaluation of the trial
17. What is the purpose of the IRB/IEC?: To protect subject safety
18. Who is responsible for providing the trial protocol?: The sponsor
19. What does DSMB stand for?: Data and Safety Monitoring Board
20. One of the primary purposes of a Phase 1 study is to:: Determine the
metabolic and pharmacologic action of the drug in humans
21. What is the purpose of the DSMB?: To assess the progress of a clinical trial,
the safety data, and the critical efficacy endpoints
22. An investigator can be defined as...: 1. A person responsible for writing the
trial protocol
2. A person responsible for the conduct of the clinical trial with the sponsor
3. A person responsible for the conduct of the clinical trial at the trial site.
23. A potential investigator usually only receives a protocol IB to review from
a sponsor:: After the signing of a confidentiality agreement
24. Which of the following is NOT one of the required elements of an informed
consent form?: A listing of all site personnel who will be involved in the research
25. Hoe should SAEs be reported?: To the sponsor immediately and to the
IRB/IEC if applicable
26. After a SAE has occurred, how should subject identification occur on the
immediate and f/u reports?: By their subject identification number
27. In the event of a subject's death, what additional info should be supplied
to the sponsor?: 1. An autopsy report, if available
2. Terminal medical reports, if available
28. What documentation should be supplied to the sponsor before the study?-
: 1. The signed contract between sponsor and investigator
2. The CVs of all investigators and other study personnel who are significantly
involved in trial related duties
29. Who must sign the ICF?: 1. The subject with the subject's legal representative
2. The person who conducted the informed consent interview
30. What details need to be documented in the subject notes when an AE
occurs?: 1. The severity of the event
2. When the event occurred
31. Who is responsible for the appropriate monitoring of clinical trials?: The
sponsor
32. During the trial, who is responsible for communicating with the IRB/IEC?-
: The investigator
