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ACRP Certified Professional Exam Sample Questions (Q62-Q67):

NEW QUESTION # 62
Who on the local site research study team is accountable for the unblinding documentation of IP?

A. Pharmacist
B. PI
C. CRC
D. Regulatory manager

Answer: B

Explanation:
The Principal Investigator (PI) is ultimately responsible for maintaining and documenting any unblinding events related to the investigational product (IP). This accountability ensures that any instance where the blind is broken is properly justified, documented, and reported to maintain trial integrity.
GCP guidelines state that the PI must oversee the unblinding process and ensure proper documentation to protect the validity of the trial data.
"The PI is responsible for ensuring that any unblinding of the investigational product is adequately documented and reported according to protocol." Objectives:
* Maintain the integrity of blinded studies.
* Properly document unblinding incidents.

NEW QUESTION # 63
One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

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

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 # 64
A serious unexpected ADR is one:

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

Answer: D

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 # 65
A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A. Protocol
B. IB
C. ICF
D. Package insert

Answer: C

Explanation:
The Informed Consent Form (ICF) contains comprehensive information about the potential risks and benefits of participation in a clinical trial. It is a legally required document that ensures that subjects make an informed decision before enrollment.
The answer is consistent with GCP guidelines which mandate that the ICF clearly outlines the risks and benefits of participation to protect participant rights.
"The ICF should include a clear explanation of potential risks and benefits to ensure informed decision- making by the participant." Objectives:
* Ensure informed decision-making by potential subjects.
* Provide transparent risk-benefit information.

NEW QUESTION # 66
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

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

Answer: B

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 # 67
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