最新的SOCRA CCRP免費考試真題

問題1

After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?

A. The regulatory authority

B. The sponsor

C. The IRB/IEC

D. The Data Safety Monitoring Board

正確答案: B

說明：（僅 Fast2test 成員可見）

問題2

If a subject experiences a serious adverse event related to the study drug and only minimal information is available, the investigator must submit the information to the:

A. Sponsor and IRB/IEC within five days

B. Sponsor and IRB/IEC within seven days

C. IRB/IEC immediately, then sponsor when full details are available

D. Sponsor and IRB/IEC immediately, then update later

正確答案: D

說明：（僅 Fast2test 成員可見）

問題3

According to the CFR and ICH GCP, an IRB/IEC must retain all relevant records for how many years after project completion?

A. Two years

B. Four years

C. One year

D. Three years

正確答案: D

說明：（僅 Fast2test 成員可見）

問題4

While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?

A. A subject's signature is missing on the copy of the summary of the short form consent

B. Only the signatures of the person obtaining consent and the witness appear on the copy of the summary of the short form consent

C. The sponsor-generated informed consent template is missing required elements

D. A copy of the consent document was not provided to a subject

正確答案: D

說明：（僅 Fast2test 成員可見）

問題5

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?

A. A sub-investigator

B. The sponsor's study monitor

C. The sponsor's medical monitor

D. An independent physician

正確答案: D

說明：（僅 Fast2test 成員可見）

問題6

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. Printouts of electronic source documents and the remaining investigational product

B. A copy of the final report for the IRB and investigational product shipment records

C. Informed consent documents and printouts of electronic source documents

D. Informed consent documents and investigational product documentation

正確答案: D

說明：（僅 Fast2test 成員可見）

問題7

A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:

A. Completed other relevant research projects

B. Obtained malpractice insurance

C. Confirmed that the site's SOPs are in place

D. Read and understood the investigator's brochure

正確答案: D

說明：（僅 Fast2test 成員可見）

問題8

Which of the following would be considered an addendum to an investigator's brochure for an unapproved Investigational Product?

A. A Suspected Unexpected Serious Adverse Reaction (SUSAR) report

B. Revisions to the risk section of the informed consent form

C. A site-specific SAE report

D. Product monograph updates

正確答案: A

說明：（僅 Fast2test 成員可見）

最新的SOCRA Certified Clinical Research Professional (CCRP) - CCRP免費考試真題

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