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ACRP Certified Professional Exam Sample Questions (Q54-Q59):

NEW QUESTION # 54
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A. Consult with the IRB/IEC first.
B. Allow access to the entire records.
C. Redact subject identification for privacy protection.
D. Deny the request until the sponsor approves.

Answer: B

Explanation:
Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.
According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.
"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights." Objectives:
* Ensure compliance with inspection requirements.
* Maintain transparency with regulatory authorities.

NEW QUESTION # 55
Who on the local site research study team is accountable for the unblinding documentation of IP?

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

Answer: C

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 # 56
After the completion or termination of a clinical trial, who should store the enrollment log?

A. Sponsor
B. Regulatory authority
C. PI
D. CRO

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for maintaining and securely storing essential documents, including the enrollment log, after the completion or termination of a clinical trial. This ensures that all participant-related records are retained for audit or inspection as per regulatory requirements.
This answer is consistent with GCP guidelines, which specify that the PI is accountable for retaining essential trial documents at the study site.
"The investigator should maintain records of trial participants, including the enrollment log, as part of the essential documents for trial conduct." Objectives:
* Maintain data integrity and compliance with record-keeping requirements.
* Ensure secure and accessible storage of participant information.

NEW QUESTION # 57
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A. Medical monitor.
B. Regulatory authority.
C. Sponsor.
D. IRB/IEC.

Answer: C

Explanation:
The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.
GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.
"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability." Objectives:
* Maintain accurate IP accountability.
* Comply with sponsor requirements for IP management.

NEW QUESTION # 58
A study protocol must contain which of the following elements?

A. Data management plan
B. Chemical structure of the IP
C. Participant reimbursement details
D. Description of statistical methods

Answer: D

Explanation:
A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.
GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.
"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results." Objectives:
* Maintain transparency in data analysis.
* Ensure scientific rigor in evaluating study outcomes.

NEW QUESTION # 59
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