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弊社のACRP-CP問題集は大勢の専門家たちの努力で開発される成果です。初心者といい、数年IT仕事を従事した人といい、我々TopexamのACRP ACRP-CP問題集は最良の選択であると考えられます。なぜならば、弊社は高品質かつ改革によってすぐに更新できるACRP-CP問題集を提供できるからです。
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弊社のIT業で経験豊富な専門家たちが正確で、合理的なACRP ACRP-CP認証問題集を作り上げました。 弊社の勉強の商品を選んで、多くの時間とエネルギーを節約こともできます。
ACRP Certified Professional Exam 認定 ACRP-CP 試験問題 (Q75-Q80):
質問 # 75
The PI should ensure that source data is:
正解:C
解説:
The PI is responsible for ensuring that the source data is accurately recorded in the electronic Case Report Forms (eCRFs). This accurate transposition of data is critical to maintaining data integrity and ensuring that the data collected at the site is consistent with the reported clinical outcomes.
GCP guidelines specify that source data should be accurate, legible, and directly reflected in the CRFs to maintain consistency and reliability.
"The PI must ensure that the source data are accurately and completely recorded in the eCRFs to maintain data integrity." Objectives:
* Ensure accurate data transposition from source to CRF.
* Maintain high standards of data quality and reliability.
質問 # 76
A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?
正解:B
解説:
Since the Wi-Fi connectivity is inconsistent, the CRA must assess the risk and report it to the trial sponsor for a decision. Accepting the site without proper risk evaluation may compromise the monitoring of the investigational product (IP) storage conditions, affecting trial integrity.
The answer follows GCP guidelines that emphasize assessing potential risks during site selection and involving the sponsor when critical issues arise.
"When faced with site-specific issues that may affect data integrity or product safety, the CRA should consult with the sponsor before making a final decision." Objectives:
* Ensuring proper site selection
* Managing potential risks proactively
質問 # 77
A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?
正解:D
解説:
Before destroying any essential documents, the site must obtain written confirmation from the sponsor that these documents are no longer needed. This ensures compliance with regulatory requirements, as some countries may require document retention for longer periods, even after study closure and marketing approval.
GCP guidelines state that the sponsor must confirm in writing that essential documents can be destroyed after ensuring compliance with local regulations.
"Before destroying essential documents, written confirmation from the sponsor is required to ensure compliance with regulatory retention policies." Objectives:
* Maintain compliance with document retention regulations.
* Prevent premature destruction of essential trial records.
質問 # 78
Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?
正解:B
解説:
The sponsor is responsible for ensuring that agreements are in place with all involved parties (including investigators and institutions) to grant direct access to trial-related source documents. This is crucial for monitoring, auditing, and inspection purposes, ensuring transparency and compliance with regulatory requirements.
According to GCP guidelines, the sponsor must establish agreements to secure direct access to trial data for verification and compliance checks.
"The sponsor should ensure that agreements are in place to permit direct access to source data and documents for monitoring and inspection." Objectives:
* Maintain compliance with regulatory requirements.
* Facilitate data verification and quality assurance.
質問 # 79
Who must be blinded in a double-blind study in order to prevent bias?
正解:D
解説:
In a double-blind study, both the participant (subject) and the investigator (or clinical staff administering the treatment) are blinded. This approach minimizes bias in treatment administration and outcome assessment.
Blinding the subject ensures that their responses are not influenced by their knowledge of the treatment they are receiving.
According to GCP guidelines, double-blinding is essential to eliminate both participant and investigator bias, ensuring objective trial results.
"Double-blind studies ensure that neither the participant nor the investigator knows which intervention is being administered, thereby minimizing bias." Objectives:
* Maintain the integrity of the study by preventing bias.
* Enhance the validity of trial outcomes.
質問 # 80
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Head office:
Farmview Supermarket, (Level -5), Farmgate, Dhaka-1215
Corporate office:
18, Indira Road, Farmgate, Dhaka-1215
Branch Office:
109, Orchid Plaza-2, Green Road, Dhaka-1215