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ACRP Certified Professional Exam Sample Questions (Q108-Q113):
NEW QUESTION # 108
When designing a clinical trial, why is it important to define the study population?
- A. To support subject recruitment to the study
- B. To support the study objectives
- C. To determine where to conduct the study
- D. To determine the study objectives
Answer: B
Explanation:
Defining the study population is crucial because it ensures that the trial targets the appropriate group for evaluating the investigational product (IP). A well-defined population supports the study objectives by providing reliable and interpretable data that can address the research questions.
GCP guidelines emphasize the need for a clearly defined study population to ensure the generalizability and accuracy of trial results.
"The study population must be clearly defined to ensure that the trial data are relevant and applicable to the intended patient group." Objectives:
* Enhance the scientific validity of clinical trial outcomes.
* Support the accurate interpretation of efficacy and safety data.
NEW QUESTION # 109
Which of the following should be considered when implementing a risk-based monitoring plan?
- A. 100% source document review is mandatory.
- B. Monitoring schedule must be pre-defined in the monitoring plan.
- C. Centralized monitoring must be incorporated in any trials.
- D. On-site monitoring frequency may change depending on the quality of the data.
Answer: D
Explanation:
Risk-based monitoring focuses on adapting the frequency and intensity of on-site visits based on data quality and site performance. If the data is consistently accurate and reliable, the monitoring frequency may be reduced. Conversely, if issues are identified, more frequent monitoring may be necessary.
GCP guidelines emphasize a flexible approach to monitoring, allowing adjustments based on the risk profile and quality of data collected.
"Risk-based monitoring involves adapting the frequency of on-site visits according to the quality of the data and the site's compliance level." Objectives:
* Implement a dynamic monitoring strategy.
* Enhance efficiency while maintaining data integrity.
NEW QUESTION # 110
The composition of an IDMC/DSMB should include which one of the following?
- A. A lead PI for the study
- B. A clinical scientist who is knowledgeable in the appropriate discipline
- C. A member from the IRB/IEC
- D. A sponsor representative who is knowledgeable about the study's unblinded information
Answer: B
Explanation:
An Independent Data Monitoring Committee (IDMC) or Data and Safety Monitoring Board (DSMB) should include clinical scientists who are knowledgeable in the relevant medical and scientific areas. Their role is to objectively assess the ongoing safety data and efficacy of the investigational product, ensuring that participants' safety is not compromised.
GCP guidelines emphasize the need for experienced clinical scientists on IDMC/DSMBs to ensure that safety data is interpreted accurately and professionally.
"IDMC/DSMB should comprise independent experts, including clinical scientists, who have the expertise to evaluate safety and efficacy data objectively." Objectives:
* Ensure impartial evaluation of safety data.
* Maintain scientific integrity in monitoring clinical trials.
NEW QUESTION # 111
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:
- A. IRB/IEC.
- B. Sponsor.
- C. Regulatory authority.
- D. Medical monitor.
Answer: B
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 # 112
While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?
- A. There are no circumstances under which this person can be enrolled.
- B. Locate a translator and have them work with the person.
- C. Have the Principal Investigator consent the person.
- D. Get an impartial witness involved in consenting this person.
Answer: D
Explanation:
When a participant cannot read, an impartial witness must be present during the consent process. The witness ensures that the information is accurately presented and that the subject's consent is truly informed. The witness must sign the consent form to attest that the subject understands the information.
GCP guidelines require the use of an impartial witness during the informed consent process for individuals who are illiterate or visually impaired.
"Informed consent must involve an impartial witness when the subject cannot read, ensuring the consent process is conducted ethically." Objectives:
* Maintain ethical standards during consent.
* Protect the rights of participants with literacy challenges.
NEW QUESTION # 113
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