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ACRP Certified Professional Exam Sample Questions (Q68-Q73):
NEW QUESTION # 68
A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?
- A. Use a central IRB/IEC.
- B. Rely on the sponsor to notify the IRB/IEC.
- C. Decline the study.
- D. Recruit for the study without use of social media.
Answer: C
Explanation:
If the IRB/IEC has a policy that does not permit social media recruiting, the site must adhere to these regulations. Proceeding with a method not approved by the IRB/IEC would violate compliance requirements, so declining the study is the correct course of action.
The answer aligns with IRB/IEC regulations that prioritize ethical and compliant recruitment methods.
"Sites must follow the recruitment methods approved by their IRB/IEC to maintain compliance and ethical standards." Objectives:
* Adhering to ethical recruitment practices.
* Maintaining compliance with IRB/IEC policies.
NEW QUESTION # 69
Who is responsible for submitting a protocol amendment to the IRB/IEC?
- A. CRC
- B. CRA
- C. Investigator
- D. Sponsor
Answer: C
Explanation:
The investigator holds the responsibility for submitting any protocol amendments to the IRB/IEC for review and approval. This step ensures that all changes are ethically evaluated before being implemented, maintaining compliance with regulatory requirements.
According to GCP guidelines, the investigator must submit protocol changes to the IRB/IEC to secure approval before making any modifications to the study.
"The investigator must inform the IRB/IEC of any proposed protocol changes and secure approval prior to implementation." Objectives:
* Maintain ethical oversight in study modifications.
* Adhere to regulatory submission requirements.
NEW QUESTION # 70
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?
- A. Allow access to the entire records.
- B. Consult with the IRB/IEC first.
- C. Redact subject identification for privacy protection.
- D. Deny the request until the sponsor approves.
Answer: A
Explanation:
Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.
According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.
"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights." Objectives:
* Ensure compliance with inspection requirements.
* Maintain transparency with regulatory authorities.
NEW QUESTION # 71
Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?
- A. Dispose of IP and request replacement from sponsor.
- B. Quarantine IP without registering in IWRS and request replacement from sponsor.
- C. Register IP in IWRS and continue with subject allocation.
- D. Register IP in IWRS, quarantine and notify sponsor of the excursion.
Answer: D
Explanation:
If a temperature-controlled IP has experienced a temperature excursion during transport, the appropriate action is to register the IP in the Interactive Web Response System (IWRS), quarantine it to prevent use, and immediately notify the sponsor. This procedure ensures that the IP is not used until the sponsor evaluates its stability and suitability.
GCP guidelines state that any IP affected by a temperature excursion should be quarantined and reported to the sponsor for evaluation.
"Upon identification of a temperature excursion, the IP must be quarantined and reported to the sponsor to determine its usability." Objectives:
* Maintain IP integrity and compliance with storage conditions.
* Follow protocol for managing temperature excursions.
NEW QUESTION # 72
Which one of the following is a primary objective of a Phase III study of a new IP?
- A. To demonstrate or confirm therapeutic benefit
- B. To establish the safety profile
- C. To establish dose information
- D. To show superiority over another treatment
Answer: A
Explanation:
Phase III clinical trials primarily aim to demonstrate or confirm the therapeutic benefit of a new investigational product (IP) compared to standard treatments or placebo. These trials are typically larger and are designed to provide robust evidence of efficacy and further evaluate safety.
According to GCP guidelines, Phase III trials focus on confirming the therapeutic efficacy of the IP in a larger population.
"Phase III trials aim to confirm the therapeutic benefit and safety of the investigational product compared to existing treatments." Objectives:
* Confirm therapeutic efficacy.
* Provide comprehensive safety data.
NEW QUESTION # 73
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