問題1
An unconscious patient experiencing life-threatening cardiac arrhythmias has been admitted to an emergency room. No FDA-approved treatment is available, and no legal representative is present. The clinical investigator determined that the use of an investigational antiarrhythmic drug is required. In accordance with the CFR, who must certify the investigator's determination?
An unconscious patient experiencing life-threatening cardiac arrhythmias has been admitted to an emergency room. No FDA-approved treatment is available, and no legal representative is present. The clinical investigator determined that the use of an investigational antiarrhythmic drug is required. In accordance with the CFR, who must certify the investigator's determination?
正確答案: A
說明：（僅 NewDumps 成員可見）
問題2
During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?
During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?
正確答案: A
說明：（僅 NewDumps 成員可見）
問題3
The study coordinator for a new Phase III vaccine study is preparing documents for IRB/IEC submission.
According to the ICH GCP Guidelines, which of the following documents should be included in the submission?
The study coordinator for a new Phase III vaccine study is preparing documents for IRB/IEC submission.
According to the ICH GCP Guidelines, which of the following documents should be included in the submission?
正確答案: D
說明：（僅 NewDumps 成員可見）
問題4
A physician wants to conduct research using an approved/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. In this case, the physician must obtain which of the following?
A physician wants to conduct research using an approved/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. In this case, the physician must obtain which of the following?
正確答案: B
說明：（僅 NewDumps 成員可見）
問題5
A clinical investigator wants to publish a subject's unique results. The consent form did not mention publication. What is required?
A clinical investigator wants to publish a subject's unique results. The consent form did not mention publication. What is required?
正確答案: A
說明：（僅 NewDumps 成員可見）
問題6
Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?
Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?
正確答案: B
說明：（僅 NewDumps 成員可見）
問題7
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
正確答案: A
說明：（僅 NewDumps 成員可見）
問題8
A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?
A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?
正確答案: B
說明：（僅 NewDumps 成員可見）
問題9
For a Significant Risk device study, an investigator must report within 5 working days which event?
For a Significant Risk device study, an investigator must report within 5 working days which event?
正確答案: D
說明：（僅 NewDumps 成員可見）
問題10
A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?
A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?
正確答案: B
說明：（僅 NewDumps 成員可見）