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ACRP Certified Professional Sample Questions:
1. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?
A) Investigator
B) Monitor
C) Coordinator
D) Sponsor
2. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
A) Applicable regulatory authorities
B) Applicable site SOPs
C) Sponsor
D) PI
3. A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?
A) After the protocol amendment is approved by the IRB/IEC
B) When the need for the additional data is discovered
C) As soon as the protocol amendment is submitted to the IRB/IEC
D) After the original planned data collection is completed
4. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?
A) Time to occurrence of symptoms of the disease
B) Occurrence of known side effects of the IP
C) Use of concomitant medications to treat the symptoms
D) Impact of an approved vaccine against the disease
5. Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?
A) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
B) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
C) The CRC is responsible for identifying the relationship of an SAE to the IP.
D) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: A | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: A |
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