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ACRP Certified Professional Exam Sample Questions (Q90-Q95):

NEW QUESTION # 90
Source data/documentation should be:

A. Attributable, legible, contemporaneous, original, accurate, and clear.
B. Attributable, legible, contemporaneous, original, accurate, and complete.
C. Attributable, legible, correct, original, accurate, and clear.
D. Attributable, legible, correct, original, accurate, and complete.

Answer: B

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 # 91
IP is dispensed to all subjects who:

A. Are eligible to receive it in the trial.
B. Consented for the trial.
C. Need IP for their medical condition.
D. Screened for the trial.

Answer: A

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 # 92
A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A. No, the PI does not have the resources to perform all protocol-required procedures.
B. No, the PI is taking part in too many ongoing studies to participate in this study.
C. Yes, the PI can perform other imaging scans instead of the PET scans.
D. Yes, the PI has a sufficient patient population to take part in this study.

Answer: A

Explanation:
The PI lacks access to a PET scanner, a required element for conducting the study according to the protocol.
Without this essential equipment, the PI cannot fully meet the study requirements, making it unsuitable for the sponsor to select this site. Compliance with the protocol's technical requirements is crucial for the trial's success.
GCP guidelines state that investigators must have access to all necessary facilities and equipment to conduct the trial as outlined in the protocol.
"The investigator must have adequate resources, including access to required equipment, to perform the study as specified." Objectives:
Ensure site readiness for protocol requirements.
Prevent protocol deviations due to inadequate resources.

NEW QUESTION # 93
Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A. How effective is the drug at treating patients that have been previously diagnosed with cancer?
B. How likely are patients at high risk of cancer going to develop cancer during the study?
C. How does the risk of developing cancer compare to the anticipated side effects from the drug?
D. How willing are current patients to participate in a trial with potentially serious side effects?

Answer: C

Explanation:
Before initiating a clinical trial with a drug that has potentially serious side effects, it is essential to evaluate the risk-benefit ratio. The primary consideration is whether the potential benefits (reduced cancer risk) outweigh the risks (serious side effects). This assessment is fundamental to ethical clinical trial design.
The answer is verified as per GCP and ethical guidelines, which require a thorough assessment of risk versus benefit before conducting human trials.
"An assessment of potential benefits versus risks is a fundamental principle in the ethical design of clinical trials, especially when potential adverse effects are severe." Objectives:
* Ensure ethical considerations in trial design.
* Assess the potential harm versus benefit to participants.

NEW QUESTION # 94
Which of the following elements of the Informed Consent are NOT required?

A. Subject legal rights can be waived
B. Statement that study involves research
C. A description of any reasonably foreseeable risks or discomforts
D. A description of potential benefits

Answer: A

Explanation:
Informed consent must not include any language that implies a waiver of the participant's legal rights or releases the investigator, sponsor, or institution from liability for negligence. Such language violates ethical standards and the principles of voluntary participation.
According to GCP guidelines and ethical principles, the informed consent document must not include any clause that waives a participant's legal rights.
"An informed consent form must not include language that waives the participant's legal rights or releases the sponsor or investigator from liability." Objectives:
* Protect participant rights in clinical trials.
* Ensure that consent is given voluntarily and ethically.

NEW QUESTION # 95
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Valid ACRP New ACRP-CP Exam Duration Are Leading Materials & Free Download Exam ACRP-CP Preparation

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ACRP Certified Professional Exam Sample Questions (Q90-Q95):

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