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Exam ACRP-CP Vce Format | ACRP-CP Guide Torrent

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ACRP Certified Professional Exam Sample Questions (Q40-Q45):

NEW QUESTION # 40
The coding system for a double-blind clinical trial is accessible by the:

A. Sponsor
B. IRB/IEC
C. Regulatory authority
D. PI

Answer: A

Explanation:
The sponsor is typically responsible for maintaining the code that links the treatment assignment to participants in a double-blind clinical trial. The code is securely maintained and is only accessible in cases where unblinding is necessary for safety reasons. This process helps to preserve the integrity of the study while allowing for emergency unblinding if needed.
GCP guidelines state that the sponsor should maintain the blind unless unblinding is necessary due to safety concerns or regulatory requirements.
"The sponsor maintains the randomization code and ensures that unblinding occurs only when necessary, to protect the study's integrity." Objectives:
* Maintain the integrity of double-blind trials.
* Allow controlled access to randomization codes.

NEW QUESTION # 41
When assessing the monitoring needs for a study, sponsors should:

A. Permit PIs to select a monitor for their site as long as they are independent of the PI.
B. Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
C. Use central monitoring instead of conducting physical monitoring visits at sites.
D. Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.

Answer: D

Explanation:
Sponsors must ensure that monitors are adequately qualified, possessing the necessary scientific and clinical knowledge to effectively oversee the trial. This ensures that monitors can accurately assess protocol compliance, data integrity, and participant safety. The quality of monitoring directly impacts the credibility of the trial outcomes.
GCP guidelines specify that monitors must be adequately trained and knowledgeable about the trial protocol, investigational product (IP), and clinical research standards.
"The sponsor must ensure that monitors have appropriate qualifications and training to conduct effective trial monitoring." Objectives:
* Maintain data integrity through skilled monitoring.
* Ensure patient safety and protocol compliance.

NEW QUESTION # 42
After the site qualification visit report has been finalized, it must be:

A. Kept in the CRO/sponsor's trial master file.
B. Sent to the IRB/IEC for review and approval.
C. Included in the PI's regulatory file.
D. Stored in the sponsor's budgets and contracts file.

Answer: A

Explanation:
The finalized site qualification visit report must be maintained in the sponsor's trial master file (TMF) as part of the essential documents. The TMF serves as the repository for all documents that demonstrate compliance with the protocol and regulatory requirements. Storing the report in the TMF ensures traceability and documentation of the site's suitability for conducting the trial.
GCP guidelines require that site qualification visit reports be included in the trial master file to maintain comprehensive documentation of site assessments.
"Finalized site qualification visit reports must be stored in the sponsor's trial master file to ensure proper documentation and compliance." Objectives:
* Maintain documentation of site qualifications.
* Ensure compliance through comprehensive record-keeping.

NEW QUESTION # 43
A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A. Complete
B. Attributable
C. Original
D. Contemporaneous

Answer: A

Explanation:
The missing data indicates a lack of completeness in the study documentation. Completeness is a fundamental requirement in clinical trials, as all necessary information must be recorded accurately and in full. Missing vital signs such as heart rate and temperature can compromise the validity of the data and affect the study's outcomes.
GCP guidelines state that all data collected during the study must be complete, accurate, and consistent with source documents.
"Clinical trial documentation must be complete, containing all data as required by the protocol toensure data integrity." Objectives:
* Ensure comprehensive data recording.
* Maintain accuracy and completeness in study records.

NEW QUESTION # 44
SAEs must be reported immediately by the site to the:

A. Sponsor.
B. IRB/IEC.
C. Regulatory agency.
D. DSMB/IDMC.

Answer: A

Explanation:
Serious Adverse Events (SAEs) must be reported immediately to the sponsor. The sponsor then assesses the severity, causality, and potential impact on the study and decides whether further reporting to regulatory authorities and IRB/IEC is required. Immediate reporting ensures that appropriate actions are taken to safeguard participant safety.
GCP guidelines specify that the site must notify the sponsor immediately about any SAE to ensure timely safety assessment and reporting.
"Sites must report all serious adverse events immediately to the sponsor, who will then determine the appropriate regulatory and ethical reporting requirements." Objectives:
* Ensure rapid reporting of serious adverse events.
* Maintain safety monitoring during the trial.

NEW QUESTION # 45
......

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