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ACRP Certified Professional Sample Questions:
1. Who is responsible for submitting a protocol amendment to the IRB/IEC?
A) CRA
B) Investigator
C) CRC
D) Sponsor
2. All site financial matters pertaining to a trial are listed in what document?
A) Financial disclosure
B) Protocol
C) Signed contract
D) Informed consent form
3. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?
A) CRO
B) IRB/IEC
C) Investigator
D) Sponsor
4. A study protocol must contain which of the following elements?
A) Description of statistical methods
B) Participant reimbursement details
C) Data management plan
D) Chemical structure of the IP
5. 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) Immediately unblind the entire trial to ensure patient safety.
C) Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
D) Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: C | Question # 3 Answer: D | Question # 4 Answer: A | Question # 5 Answer: C |





