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1. An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A) Investigator at each site
B) Regulatory authority
C) Study sponsor
D) Original reporting investigator

2. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Train the research coordinator on the required study assessments schedule.
B) Identify critical processes and data during protocol development.
C) Perform a periodic review to see if the quality methods are effective and relevant.
D) Determine the quality tolerance limits for data transcription errors.

3. 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) Rely on the sponsor to notify the IRB/IEC.
B) Decline the study.
C) Use a central IRB/IEC.
D) Recruit for the study without use of social media.

4. During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

A) Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
B) Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
C) Immediately unblind the entire trial to ensure patient safety.
D) Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.

5. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Investigator
B) Monitor
C) Coordinator
D) Sponsor

問題與答案：