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ACRP Certified Professional Exam Sample Questions (Q90-Q95):

NEW QUESTION # 90
IP is dispensed to all subjects who:

A. Consented for the trial.
B. Screened for the trial.
C. Need IP for their medical condition.
D. Are eligible to receive it in the trial.

Answer: D

Explanation:
The investigational product (IP) is only dispensed to subjects who meet the eligibility criteria as defined in the study protocol. Eligibility is confirmed during screening and baseline assessments. Simply consenting to the trial does not guarantee receipt of IP.
According to GCP guidelines, IP dispensing must strictly follow eligibility criteria to maintain protocol compliance and subject safety.
"IP should only be dispensed to subjects who have been deemed eligible according to the protocol's inclusion and exclusion criteria." Objectives:
* Maintain adherence to protocol criteria.
* Protect participant safety by ensuring proper eligibility.

NEW QUESTION # 91
The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

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

Answer: D

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 # 92
The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A. A family member
B. A member of the research team
C. A legally acceptable representative
D. A witness

Answer: C

Explanation:
For cognitively impaired participants who may not fully understand the informed consent process, a legally acceptable representative (LAR) must be involved. This ensures that the participant's rights and interests are protected and that consent is obtained ethically and legally.
GCP guidelines mandate that, in cases where participants are unable to provide informed consent, an LAR must be involved to make decisions on their behalf.
"When a participant is cognitively impaired, informed consent must be obtained from a legally acceptable representative to ensure ethical participation." Objectives:
* Safeguard the rights of vulnerable populations.
* Maintain ethical standards in the consent process.

NEW QUESTION # 93
A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

A. Install an air cooler requiring regular water refills to maintain the room temperature.
B. Return all IP and request the CRO/Sponsor to directly ship IP to participants.
C. Continue reporting temperature excursions per the pharmacy manual guidelines.
D. Invest in a room temperature controlled IP cabinet and transfer IP to this unit.

Answer: D

Explanation:
Investing in a temperature-controlled IP cabinet is the most effective and sustainable solution for maintaining IP stability. This cabinet can consistently regulate temperature without relying on external A/C systems, thereby minimizing the risk of excursions and ensuring compliance with storage requirements.
GCP guidelines state that IP must be stored under controlled conditions as specified by the protocol and product labeling.
"Temperature-controlled storage units should be used when site environmental conditions are not reliable to maintain IP stability." Objectives:
* Ensure IP stability and compliance.
* Mitigate temperature excursion risks effectively.

NEW QUESTION # 94
A serious unexpected ADR is one:

A. That does not need to be reported to the IRB/IEC.
B. Where the severity of the reaction is not consistent with IB.
C. That results in the death of the subject.
D. Severity and nature of the reaction is consistent with protocol.

Answer: B

Explanation:
A serious unexpected adverse drug reaction (ADR) is characterized by an event that is not consistent with the information provided in the Investigator's Brochure (IB). Such reactions may indicate new risks associated with the investigational product and warrant immediate reporting to the sponsor and regulatory authorities.
This answer follows the ICH E6(R2) GCP guidelines, which specify the criteria for reporting serious and unexpected adverse events.
"An unexpected adverse drug reaction is one whose nature or severity is not consistent with the applicable product information (e.g., IB)." Objectives:
* Understanding classification of ADRs
* Ensuring timely and accurate reporting of unexpected events

NEW QUESTION # 95
......

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