Quiz Accurate ACRP - ACRP-CP - Test ACRP Certified Professional Exam Questions Fee
Quiz Accurate ACRP - ACRP-CP - Test ACRP Certified Professional Exam Questions Fee
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ACRP Certified Professional Exam Sample Questions (Q116-Q121):
NEW QUESTION # 116
After the site qualification visit report has been finalized, it must be:
- A. Stored in the sponsor's budgets and contracts file.
- B. Kept in the CRO/sponsor's trial master file.
- C. Included in the PI's regulatory file.
- D. Sent to the IRB/IEC for review and approval.
Answer: B
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 # 117
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. Recording data on source documents at the time the data are collected during the conduct of the study.
- C. Recording the date and time each data element is entered onto the source document.
- D. Allowing real-time access for data review in the eCRF.
Answer: B
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 # 118
Who should vote during the IRB/IEC review and discussion process?
- A. All members who were involved in the review and discussion and non-member experts
- B. All IRB/IEC members and non-member experts
- C. All members who were involved in the review and discussion
- D. All IRB/IEC members
Answer: C
Explanation:
During the IRB/IEC review process, only members who actively participated in the review and discussion are eligible to vote. This ensures that votes are cast by those who are adequately informed about the study and can make an educated decision. Non-member experts may participate in discussions but do not have voting rights.
GCP guidelines state that voting rights in IRB/IEC meetings are limited to members who have thoroughly reviewed and discussed the study, maintaining unbiased and informed decision-making.
"Only IRB/IEC members who were involved in the review and discussion should participate in the voting process." Objectives:
* Ensure informed voting in ethical review processes.
* Maintain integrity and objectivity in IRB/IEC decisions.
NEW QUESTION # 119
The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?
- A. Time to occurrence of symptoms of the disease
- B. Occurrence of known side effects of the IP
- C. Impact of an approved vaccine against the disease
- D. Use of concomitant medications to treat the symptoms
Answer: A
Explanation:
In a clinical trial aimed at assessing whether an IP prevents disease recurrence, the primary endpoint would typically be the "time to occurrence of symptoms" indicating a relapse or recurrence. This endpoint directly measures the IP's effectiveness in prolonging the symptom-free period.
This answer follows the GCP guideline, which states that primary endpoints should directly reflect the trial's objectives, particularly when evaluating recurrence prevention.
"In trials evaluating recurrence prevention, the primary endpoint should measure the time until recurrence of the target symptoms or condition." Objectives:
* Assess the efficacy of IP in preventing disease recurrence.
* Accurately measure the time to recurrence as a primary endpoint.
NEW QUESTION # 120
Source data/documentation should be:
- A. Attributable, legible, correct, original, accurate, and complete.
- B. Attributable, legible, contemporaneous, original, accurate, and clear.
- C. Attributable, legible, correct, original, accurate, and clear.
- D. Attributable, legible, contemporaneous, original, accurate, and complete.
Answer: D
Explanation:
Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high- quality, reliable, and verifiable clinical trial records.
GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.
"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards." Objectives:
* Maintain data integrity and reliability.
* Adhere to best practices in clinical documentation.
NEW QUESTION # 121
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