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1. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) Investigator
B) DSMB/IDMC
C) Health authority
D) Sponsor

2. 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.

3. The coding system for a double-blind clinical trial is accessible by the:

A) IRB/IEC
B) Regulatory authority
C) PI
D) Sponsor

4. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

A) Locate a translator and have them work with the person.
B) Get an impartial witness involved in consenting this person.
C) There are no circumstances under which this person can be enrolled.
D) Have the Principal Investigator consent the person.

5. Who should vote during the IRB/IEC review and discussion process?

A) All members who were involved in the review and discussion
B) All IRB/IEC members
C) All IRB/IEC members and non-member experts
D) All members who were involved in the review and discussion and non-member experts

問題與答案：