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ACRP ACRP-CP Sample Question Answers
Question # 1
While reviewing a new protocol, a PI realizes a specialized laboratory test is required thatthe local hospital does not perform. The PI locates a laboratory that performs thespecialized test and retains their services. Responsibility for ensuring the laboratoryretained is qualified for this trial-related task lies with the:
A. PI B. CRC C. CRO D. Sponsor
Answer: A
Question # 2
The inclusion and exclusion criteria are in place so all subjects are:
A. Healthy and willing to complete the clinical trial. B. Patients with the disease under study and will not have any adverse events. C. Medically appropriate and protected from ethical vulnerability. D. Ethically vulnerable and patients with the disease under study.
Answer: C
Question # 3
Which of the following should be reviewed and evaluated by qualified experts to assessimplications for the safety of the trial subjects?
A. PI roles and responsibilities B. Project feasibility considerations C. Emerging animal toxicological and clinical data D. Sample collection storage, disposal, and shipment requirements
Answer: C
Question # 4
Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?
A. CRO B. IRB/IEC C. Sponsor-Investigator D. Regulatory authority
Answer: C
Question # 5
Which strategy is used to safeguard subject privacy?
A. Store source documentation in the CRC's office. B. Email updated enrollment logs to the CRA. C. Utilize subject initials on correspondence. D. Conduct subject-related conversations in controlled environments.
Answer: D
Question # 6
A protocol requires participants to take IP for 6 months. The protocol allows for anyparticipants who are noncompliant to be replaced by enrolling additional participants,except if it is due to an AE. The investigator has enrolled 12 participants.The status of the enrolled participants is as follows:3 participants were withdrawn due to noncompliance1 participant withdrew consent after experiencing severe nausea1 participant had to discontinue IP for an unscheduled hospitalization1 participant who is not returning for visits2 participants completed the 6 months of treatment4 participants currently on IPHow many participants should be replaced?
A. 3 participants B. 4 participants C. 5 participants D. 6 participants
Answer: A
Question # 7
Source data/documentation should be:
A. Attributable, legible, contemporaneous, original, accurate, and complete. B. Attributable, legible, contemporaneous, original, accurate, and clear. C. Attributable, legible, correct, original, accurate, and complete. D. Attributable, legible, correct, original, accurate, and clear.
Answer: A
Question # 8
The investigator/institution should permit:
A. Monitoring and inspection by the appropriate regulatory authority(ies), and auditing bythe sponsor. B. Monitoring and inspection by the sponsor, and auditing by the appropriate regulatoryauthority(ies). C. Monitoring and auditing by the appropriate regulatory authority(ies), and inspection bythe sponsor. D. Monitoring and auditing by the sponsor, and inspection by the appropriate regulatoryauthority(ies).
Answer: A
Question # 9
A deferred consent can take place in which of the following situations?
A. Only when the PI approves such a consent process, regardless of the emergencysituation described in the protocol. B. In an emergency situation only, when this process is described in the protocol and hasreceived permission from the ethics committee. C. Only when the PI approves such a consent process immediately prior to patientenrollment, regardless of the situation being classed as emergency. D. In an emergency situation only, even when this process is not described in the protocol,but the sponsor approves the consent process.
Answer: B
Question # 10
The PI should ensure that source data is:
A. Kept on site for a minimum of 2 years. B. Accurately reflected in the eCRFs. C. Printed directly from the EMR. D. On worksheets that are provided by the sponsor.
Answer: B
Question # 11
A study drug will be shipped, stored, and mixed at the hospital pharmacy and will betransferred to the study site for infusion. Which document describes how the transfer willoccur?
A. Standard Operating Procedure B. Data & Safety Monitoring Plan C. Clinical Monitoring Plan D. Investigator's Brochure
Answer: A
Question # 12
Who is responsible for the ongoing safety evaluation of the IP?
A. Regulatory agency B. IRB/IEC C. Sponsor D. PI
Answer: C
Question # 13
Which of the following would the sponsor need to do FIRST to set up an effective clinicaltrial quality management system (QMS)?
A. Perform a periodic review to see if the quality methods are effective and relevant. B. Train the research coordinator on the required study assessments schedule. C. Determine the quality tolerance limits for data transcription errors. D. Identify critical processes and data during protocol development.
Answer: D
Question # 14
The sponsor must report a serious unexpected AE to the regulatory authorities within amaximum of:
A. 7 calendar days B. 8 calendar days C. 15 calendar days D. 30 calendar days
Answer: C
Question # 15
An interim analysis is conducted during a clinical trial. To review the results, the sponsorassigns:
A. Executive board members. B. Independent qualified individuals. C. Regulatory authority expert advisors. D. Investigators participating in the trial.
Answer: B
Question # 16
In an investigator-initiated study, who is responsible for implementing appropriatecorrective and preventive actions when significant non-compliance is discovered?
A. PI B. IRB/IEC C. CRA D. CRC
Answer: A
Question # 17
Which one of the following is a primary objective of a Phase III study of a new IP?
A. To establish the safety profile B. To establish dose information C. To demonstrate or confirm therapeutic benefit D. To show superiority over another treatment
Answer: C
Question # 18
An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor.Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?
A. Study sponsor B. Regulatory authority C. Investigator at each site D. Original reporting investigator
Answer: A
Question # 19
A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety,and endpoint evaluation, and make recommendations to continue, modify, or stop the trial.How should they proceed?
A. Draft a CAPA plan B. Establish a DSMB/IDMC C. Develop a monitoring plan D. Conduct routine investigators' meetings
Answer: B
Question # 20
All of the following are examples of what monitors review EXCEPT:
A. Regulatory binder which includes copies of current certifications for all laboratories. B. The signed ICF retained in the participant's study file. C. Potential patient medical records for eligibility prior to the informed consent process. D. Documentation in the participant's medical record of study drug administration.
Answer: C
Question # 21
Which of the following is a conflict of interest for a PI conducting a study?
A. A PI that votes on the IRB/IEC approval of the protocol B. A PI that presents at an investigator meeting C. A PI who is a key opinion leader, writes the protocol D. A PI who receives payment for the study
Answer: A
Question # 22
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of thefollowing documents?
A. Protocol, informed consent, and clinical trial agreement B. IB, site coordinator CVs, and information about payments and compensation available tosubjects C. Protocol, IB, and information about payments and compensation available to subjects D. Protocol, site coordinator CVs, and clinical trial agreement
Answer: C
Question # 23
Which of the following statements accurately describes the responsibilities of stakeholdersinvolved in the conduct of a clinical study?
A. The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study. B. The sponsor is responsible for overseeing any delegated activities to a CRO andensuring that the delegation of these activities is documented. 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 studyprotocol and accompanying CRF prior to implementation.
Answer: B
Question # 24
The objective of a randomized clinical trial is to look at whether an IP is effective inpreventing recurrence of a disease. What would be a possible primary endpoint of the trial?
A. Occurrence of known side effects of the IP B. Time to occurrence of symptoms of the disease C. Impact of an approved vaccine against the disease D. Use of concomitant medications to treat the symptoms
Answer: B
Question # 25
A potential subject is interested in a new clinical trial and would like to learn more about therisks and benefits of participation. Where can they find this information?
A. IB B. ICF C. Protocol D. Package insert
Answer: B
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