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The ACRP Certified Professional Exam (ACRP-CP) certification is a valuable credential that every ACRP professional should earn it. The ACRP ACRP-CP certification exam offers a great opportunity for beginners and experienced professionals to demonstrate their expertise. With the ACRP Certified Professional Exam (ACRP-CP) certification exam everyone can upgrade their skills and knowledge. There are other several benefits that the ACRP-CP Exam holders can achieve after the success of the ACRP Certified Professional Exam (ACRP-CP) certification exam. However, you should keep in mind to pass the ACRP ACRP-CP certification exam is not an easy task. It is a challenging job.
ACRP Certified Professional Exam Sample Questions (Q24-Q29):
NEW QUESTION # 24
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?
Answer: C
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 # 25
When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:
Answer: A
Explanation:
The primary factor in determining whether a protocol deviation should be reported to the IRB/IEC is whether the deviation impacts participant safety or the integrity of the study data. Any deviation that could pose a risk to participants must be reported promptly to ensure ongoing ethical oversight.
GCP guidelines mandate reporting of any protocol deviations that affect safety or data integrity to the IRB
/IEC.
"Protocol deviations that impact the safety of participants or the integrity of the study must be reported to the IRB/IEC." Objectives:
* Maintain participant safety.
* Ensure regulatory compliance through prompt reporting.
NEW QUESTION # 26
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?
Answer: D
Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.
NEW QUESTION # 27
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:
Answer: C
Explanation:
The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.
GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.
"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability." Objectives:
* Maintain accurate IP accountability.
* Comply with sponsor requirements for IP management.
NEW QUESTION # 28
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?
Answer: D
Explanation:
The frequency of data backup is a critical element of an Electronic Data Capture (EDC) system's Standard Operating Procedure (SOP). Ensuring regular and systematic data backup is essential for protecting trial data against loss or corruption. Failure to specify backup frequency indicates a gap in data security management.
GCP guidelines stress that data protection, including regular backups, is essential to maintaining data integrity in clinical trials.
"EDC system SOPs must include clear guidelines on data backup frequency to safeguard the integrity and availability of study data." Objectives:
* Ensure data security through regular backups.
* Maintain data integrity in clinical research.
NEW QUESTION # 29
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