ACRP-CP CERTIFICATION EXAM |115 COMPLETE QUESTIONS WITH EXPERT
SOLUTIONS | 2026 LATEST UPDATED | GET A+
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
research 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
monitor 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
conducted 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
SOLUTIONS | 2026 LATEST UPDATED | GET A+
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
research 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
monitor 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
conducted 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
