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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. The IB contains which of the following sections?

A) Known pharmacokinetic effects
B) IP preparation instructions
C) Participant eligibility criteria
D) Participant dosing schedule

2. The inclusion and exclusion criteria are in place so all subjects are:

A) Healthy and willing to complete the clinical trial.
B) Patients with the disease under study and will not have any adverse events.
C) Medically appropriate and protected from ethical vulnerability.
D) Ethically vulnerable and patients with the disease under study.

3. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A) 80%
B) 77%
C) 71%
D) 66%

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

5. A study protocol must contain which of the following elements?

A) Chemical structure of the IP
B) Data management plan
C) Participant reimbursement details
D) Description of statistical methods

Solutions: