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Varieties of ACRP ACRP-CP Exam Practice Test Questions
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ACRP Certified Professional Exam Sample Questions (Q63-Q68):
NEW QUESTION # 63
After the completion or termination of a clinical trial, who should store the enrollment log?
- A. Regulatory authority
- B. CRO
- C. Sponsor
- D. PI
Answer: D
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.
ย
NEW QUESTION # 64
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
- A. Randomization
- B. Placebo-controlled
- C. Blinding
- D. Privacy controls
Answer: A
Explanation:
Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.
GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.
"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups." Objectives:
* Maintain scientific rigor through randomization.
* Minimize selection bias in clinical studies.
ย
NEW QUESTION # 65
Which of the following reports should be retained in participant charts?
- A. Lab reports
- B. IRB/IEC progress reports
- C. DSMB/IDMC reports
- D. Safety reports
Answer: A
Explanation:
Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP).
Therefore, they must be retained in the participant's medical records.
According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.
"Lab reports must be maintained as part of the participant's chart for safety monitoring and data verification." Objectives:
* Maintain comprehensive medical records for each participant.
* Ensure availability of clinical data for audit and review.
ย
NEW QUESTION # 66
The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?
- A. The CRC should amend the medical chart.
- B. The PI should notify the monitor.
- C. The PI should amend the medical chart.
- D. The CRC should write a note to file.
Answer: C
Explanation:
The PI is responsible for ensuring accurate documentation of adverse events (AEs) in the medical chart, including their relationship to the investigational product (IP). If an omission is identified, the PI must correct it by making a dated and signed amendment to maintain data accuracy and completeness.
GCP guidelines state that the PI must maintain accurate and complete records, including the assessment of the relationship between AEs and the IP.
"The investigator must document the assessment of the relationship between the AE and the investigational product to ensure accurate clinical records." Objectives:
* Maintain accuracy in adverse event documentation.
* Ensure data integrity through appropriate corrections.
ย
NEW QUESTION # 67
At a close-out visit, which document should be retained only at the site?
- A. Treatment allocation
- B. IP accountability
- C. Subject identification code list
- D. Final trial close-out monitoring report
Answer: C
Explanation:
The subject identification code list, which links the participant's unique code to their personal information, must be retained only at the site. This list ensures confidentiality and is necessary for identifying participants during follow-up. It is not shared with the sponsor to protect participant privacy.
GCP guidelines mandate that the subject identification code list remains at the site to ensure confidentiality and compliance with data protection regulations.
"The subject identification code list must be securely stored at the site to maintain participant confidentiality." Objectives:
* Safeguard participant confidentiality.
* Maintain compliance with data protection policies.
ย
NEW QUESTION # 68
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