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PDF ACRP-CP VCE & ACRP-CP Exam Outline

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ACRP Certified Professional Exam Sample Questions (Q40-Q45):

NEW QUESTION # 40
Which of the following reports should be retained in participant charts?

A. DSMB/IDMC reports
B. Safety reports
C. Lab reports
D. IRB/IEC progress reports

Answer: C

Explanation:
Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP).
Therefore, they must be retained in the participant's medical records.
According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.
"Lab reports must be maintained as part of the participant's chart for safety monitoring and data verification." Objectives:
* Maintain comprehensive medical records for each participant.
* Ensure availability of clinical data for audit and review.

NEW QUESTION # 41
A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A. Sponsor
B. Investigator
C. Health authority
D. DSMB/IDMC

Answer: A

Explanation:
The sponsor is responsible for updating the Investigator's Brochure (IB) with new information obtained from the completed Phase I trial. The IB must reflect the most current data on the drug's safety, efficacy, and dosing to support Phase II planning and execution.
According to GCP guidelines, the sponsor must ensure that the IB is updated regularly with relevant findings from ongoing and completed trials.
"The sponsor is responsible for ensuring that the Investigator's Brochure is updated with the latest safety and efficacy data before advancing to the next phase of the trial." Objectives:
* Keep the IB current and accurate.
* Inform investigators of the latest safety and efficacy data.

NEW QUESTION # 42
The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A. Schedule a site initiation visit
B. Verify subject eligibility
C. Obtain IRB/IEC approval
D. Ship/receive IP

Answer: C

Explanation:
Before proceeding with any trial-related activities, including subject screening, the site must first obtain IRB
/IEC approval. This approval ensures that the study has been reviewed for ethical considerations, risk assessment, and adherence to regulatory requirements. Without IRB/IEC approval, initiating the study would violate ethical guidelines and regulatory standards.
GCP guidelines mandate that no clinical trial procedures, including screening, commence without prior IRB
/IEC approval.
"IRB/IEC approval must be obtained before initiating any study-related activities, including screening and subject recruitment." Objectives:
* Ensure ethical compliance before study initiation.
* Protect participant rights and safety.

NEW QUESTION # 43
The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A. 15 calendar days
B. 30 calendar days
C. 7 calendar days
D. 8 calendar days

Answer: A

Explanation:
The sponsor is required to report serious unexpected adverse events (SAEs) to the regulatory authorities within 15 calendar days from the date of awareness. This reporting period is mandated to ensure that any new safety information that may affect the risk/benefit profile of the investigational product (IP) is promptly communicated, thereby protecting participant safety.
GCP guidelines specify that serious, unexpected, and related AEs must be reported to regulatory authorities within 15 days of being known to the sponsor.
"Serious unexpected adverse reactions that may affect the safety profile of the IP must be reported within 15 calendar days to the regulatory authorities." Objectives:
* Ensure timely reporting of safety information.
* Protect the safety of trial participants.

NEW QUESTION # 44
The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:

A. Confirm subjects receive the appropriate reimbursement.
B. Safeguard the rights, safety, and well-being of all potential subjects.
C. Assure the ads do not impinge on confidentiality agreements.
D. Review the content for ethically or morally sensitive issues.

Answer: B

Explanation:
The IRB/IEC's primary responsibility when reviewing recruitment materials such as posters, fliers, social media posts, and promotional items is to ensure that these materials safeguard the rights, safety, and well- being of potential participants. This includes ensuring that the information is presented ethically, clearly, and without coercion, maintaining compliance with ethical guidelines.
GCP guidelines require that any materials used for recruitment be reviewed to ensure they do not mislead participants and that they respect their rights and well-being.
"IRB/IEC review of recruitment materials ensures that they protect participants' rights and well-being and that the content is ethically appropriate." Objectives:
* Maintain ethical standards in recruitment.
* Protect potential participants from misleading or coercive information.

NEW QUESTION # 45
......

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