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ACRP Certified Professional Exam Sample Questions (Q32-Q37):
NEW QUESTION # 32
Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?
- A. 3.6 mg/dL
- B. 2.6 mg/dL
- C. 3.0 mg/dL
- D. 1.8 mg/dL
Answer: C
Explanation:
To calculate the maximum allowable creatinine level, multiply the upper limit of normal (1.2 mg/dL) by 2.5.
1.2 x 2.5 = 3.0 mg/dL
Therefore, the maximum creatinine level that a participant can have to remain eligible for the trial is 3.0 mg
/dL.
GCP guidelines specify that eligibility criteria, including lab values, must be strictly followed to maintain protocol compliance.
"The protocol specifies that laboratory values must not exceed the defined limits to ensure participant safety and data integrity." Objectives:
* Maintain accurate interpretation of laboratory criteria.
* Ensure compliance with protocol-defined inclusion/exclusion criteria.
NEW QUESTION # 33
IP is dispensed to all subjects who:
- A. Screened for the trial.
- B. Are eligible to receive it in the trial.
- C. Consented for the trial.
- D. Need IP for their medical condition.
Answer: B
Explanation:
The investigational product (IP) is only dispensed to subjects who meet the eligibility criteria as defined in the study protocol. Eligibility is confirmed during screening and baseline assessments. Simply consenting to the trial does not guarantee receipt of IP.
According to GCP guidelines, IP dispensing must strictly follow eligibility criteria to maintain protocol compliance and subject safety.
"IP should only be dispensed to subjects who have been deemed eligible according to the protocol's inclusion and exclusion criteria." Objectives:
* Maintain adherence to protocol criteria.
* Protect participant safety by ensuring proper eligibility.
NEW QUESTION # 34
The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:
- A. Assure the ads do not impinge on confidentiality agreements.
- B. Safeguard the rights, safety, and well-being of all potential subjects.
- C. Confirm subjects receive the appropriate reimbursement.
- D. Review the content for ethically or morally sensitive issues.
Answer: B
Explanation:
The IRB/IEC's primary responsibility when reviewing recruitment materials such as posters, fliers, social media posts, and promotional items is to ensure that these materials safeguard the rights, safety, and well- being of potential participants. This includes ensuring that the information is presented ethically, clearly, and without coercion, maintaining compliance with ethical guidelines.
GCP guidelines require that any materials used for recruitment be reviewed to ensure they do not mislead participants and that they respect their rights and well-being.
"IRB/IEC review of recruitment materials ensures that they protect participants' rights and well-being and that the content is ethically appropriate." Objectives:
* Maintain ethical standards in recruitment.
* Protect potential participants from misleading or coercive information.
NEW QUESTION # 35
While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:
- A. PI
- B. CRO
- C. Sponsor
- D. CRC
Answer: A
Explanation:
The Principal Investigator (PI) is responsible for ensuring that any laboratory used for trial-related testing is appropriately qualified and certified. This includes verifying the laboratory's accreditation, quality control procedures, and ability to perform the required tests accurately. The PI must document the qualification process to ensure compliance with GCP and protocol requirements.
GCP guidelines state that the investigator is responsible for selecting and verifying the qualification of laboratories used in the study.
"The PI must ensure that any laboratory involved in the trial is properly qualified and capable of performing the specified tests according to protocol requirements." Objectives:
* Maintain quality control in laboratory testing.
* Ensure the accuracy and reliability of test results.
NEW QUESTION # 36
A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?
- A. Availability of qualified staff to conduct the trial
- B. Information to be included in the advertising flyer
- C. Location of stored trial records
- D. Length of time to receive the approved trial device
Answer: A
Explanation:
The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial's integrity and data quality are compromised.
This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.
"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements." Objectives:
* Assessing resource availability
* Ensuring readiness to initiate a clinical trial
NEW QUESTION # 37
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