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ACRP Certified Professional Exam Sample Questions (Q104-Q109):

NEW QUESTION # 104
A root cause analysis should be:

A. Focused on issues of non-compliance.
B. Written by the investigator.
C. Validated before use in a CAPA.
D. Specific to a clinical trial.

Answer: A

Explanation:
Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non- compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non- compliance ensures that the study adheres to GCP and regulatory requirements.
GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.
"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively." Objectives:
* Address non-compliance systematically.
* Develop effective CAPA plans.

NEW QUESTION # 105
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A. Protocol, informed consent, and clinical trial agreement
B. Protocol, site coordinator CVs, and clinical trial agreement
C. IB, site coordinator CVs, and information about payments and compensation available to subjects
D. Protocol, IB, and information about payments and compensation available to subjects

Answer: D

Explanation:
Before a clinical trial can begin, the IRB/IEC must review the protocol, Investigator's Brochure (IB), and any information related to payments and compensation. This review ensures that the study is ethically sound, scientifically valid, and that participants are informed about any financial considerations.
GCP guidelines specify that essential documents, including the protocol, IB, and compensation details, must be reviewed by the IRB/IEC to maintain ethical oversight.
"The IRB/IEC must evaluate the protocol, IB, and any financial disclosures to ensure ethical compliance and participant protection." Objectives:
* Guarantee ethical oversight in clinical trial conduct.
* Protect participants through informed consent and transparency.

NEW QUESTION # 106
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

A. Interview participants who have dropped out.
B. Require participants to provide documented reason for withdrawal.
C. Submit revised ICFs to the IRB/IEC with increased compensation for participants.
D. Meet with the site staff to understand their workflows and to review retention strategies.

Answer: D

Explanation:
Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.
GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.
"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions." Objectives:
* Improve participant retention through collaboration.
* Identify and address site-specific challenges.

NEW QUESTION # 107
A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A. 80%
B. 71%
C. 66%
D. 77%

Answer: D

Explanation:
Step 1:Calculate the total number of tablets dispensed:
* Month 1: 35 tablets
* Month 2: 35 tablets
* Total: 70 tablets
Step 2:Calculate the number of tablets returned:
* Month 1: 10 tablets
* Month 2: 12 tablets
* Total: 22 tablets
Step 3:Calculate the number of tablets taken:
* 70 - 22 = 48 tablets
Step 4:Calculate compliance:
* Compliance = (Tablets Taken / Total Tablets) × 100
* Compliance = (48 / 62) × 100 # 77%
GCP guidelines require accurate calculation of compliance based on returned IP counts, ensuring proper dose administration monitoring.
"Compliance rates are calculated by comparing the number of tablets taken to the total number of tablets dispensed, considering the returned count." Objectives:
* Monitor compliance with IP administration.
* Ensure accurate calculation of adherence rates.

NEW QUESTION # 108
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A. PI
B. CRA
C. IRB/IEC
D. CRC

Answer: A

Explanation:
In investigator-initiated studies, the PI holds primary responsibility for addressing non-compliance, including root cause analysis and implementation of CAPA plans. This ensures that any issues affecting the study's integrity are adequately addressed and prevented in the future.
The answer is verified based on ICH E6(R2) guidelines which emphasize the PI's responsibility for maintaining compliance at the study site.
"The PI must develop and implement corrective and preventive actions when non-compliance is identified during the study." Objectives:
* Maintain compliance in investigator-initiated studies.
* Address non-compliance through CAPA.

NEW QUESTION # 109
......

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