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ACRP Certified Professional Exam Sample Questions (Q118-Q123):

NEW QUESTION # 118
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 needs to be reported to the regulatory authorities within 10 business days.
D. This qualifies for expedited reporting to the sponsor.

Answer: D

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 # 119
A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A. QA Department
B. Monitor
C. Data Manager
D. Sponsor

Answer: B

Explanation:
After data entry into the Electronic Data Capture (EDC) system, the monitor (typically a Clinical Research Associate - CRA) conducts Source Data Verification (SDV). The monitor compares the data entered in the EDC system with the source documents to ensure accuracy, completeness, and consistency. This step is essential for maintaining data integrity and compliance with GCP standards.
GCP guidelines require that monitors verify data accuracy through SDV as part of routine monitoring responsibilities.
"The monitor is responsible for performing Source Data Verification (SDV) to ensure that the data recorded in the EDC system matches the source documents." Objectives:
* Verify data accuracy in clinical trials.
* Ensure compliance with data management protocols.

NEW QUESTION # 120
A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A. Information to be included in the advertising flyer
B. Location of stored trial records
C. Length of time to receive the approved trial device
D. Availability of qualified staff to conduct the trial

Answer: D

Explanation:
The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial's integrity and data quality are compromised.
This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.
"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements." Objectives:
* Assessing resource availability
* Ensuring readiness to initiate a clinical trial

NEW QUESTION # 121
One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

A. Recording the date and time each data element is entered onto the source document.
B. Comparing source document data to other data recorded in the same study time period.
C. Recording data on source documents at the time the data are collected during the conduct of the study.
D. Allowing real-time access for data review in the eCRF.

Answer: C

Explanation:
Contemporaneous data means that data entries are made at the time of the event or as soon as possible after the event occurs. This practice ensures that the recorded data accurately reflect the participant's condition and study procedures, minimizing recall bias and errors. Maintaining contemporaneous records is a fundamental requirement for ensuring the accuracy and reliability of clinical trial data.
GCP guidelines specify that data should be recorded as close to the time of the event as possible to ensure accuracy and reliability.
"Data must be contemporaneously recorded, meaning they are documented at the time of the occurrence to accurately reflect the study conduct." Objectives:
* Ensure accurate and real-time data capture.
* Maintain data integrity by minimizing recall bias.

NEW QUESTION # 122
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A. Regulatory Agency
B. Sponsor
C. PI
D. CRC

Answer: C

Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.

NEW QUESTION # 123
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