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ACRP Certified Professional Exam Sample Questions (Q88-Q93):

NEW QUESTION # 88
A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

A. This qualifies for prompt reporting to the IRB/IEC within 15 business days.
B. This needs to be reported to the patient's primary care physician.
C. This qualifies for expedited reporting to the sponsor.
D. This needs to be reported to the regulatory authorities within 10 business days.

Answer: C

Explanation:
Any serious adverse event (SAE) that is unexpected, especially those involving congenital anomalies or birth defects, must be reported to the sponsor as an expedited safety report. The reporting should occur immediately to ensure prompt assessment and necessary action.
The answer aligns with ICH E6(R2) GCP guidelines, which require immediate reporting of SAEs related to IP use.
"Expedited reporting to the sponsor is required for unexpected serious adverse drug reactions, particularly those involving congenital anomalies." Objectives:
* Immediate safety reporting.
* Protecting the health of trial participants and their offspring.

NEW QUESTION # 89
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. As soon as the protocol amendment is submitted to the IRB/IEC
C. When the need for the additional data is discovered
D. After the original planned data collection is completed

Answer: A

Explanation:
The research team must wait until the protocol amendment is reviewed and approved by the IRB/IEC before collecting any additional data. This ensures that any changes to the data collection process have undergone ethical review and comply with regulatory requirements. Collecting data without IRB/IEC approval would be a violation of Good Clinical Practice (GCP).
GCP guidelines clearly state that any changes to the protocol, including additional data collection, must be approved by the IRB/IEC before implementation.
"Any amendment that affects participant data collection must receive IRB/IEC approval before the change is implemented." Objectives:
* Maintain compliance with ethical standards.
* Protect participants' rights and data integrity.

NEW QUESTION # 90
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. Obtain IRB/IEC approval
B. Verify subject eligibility
C. Ship/receive IP
D. Schedule a site initiation visit

Answer: A

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 # 91
IP is dispensed to all subjects who:

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

Answer: A

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 # 92
The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A. 15 calendar days
B. 7 calendar days
C. 30 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 # 93
......

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