ACRP Certified Professional 認定 ACRP-CP 試験問題:

1. The IB contains which of the following sections?

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

2. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) Sponsor
B) PI
C) Regulatory Agency
D) CRC

3. A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

A) Re-train investigators on recruitment obligations.
B) Evaluate the screen failures to determine if the protocol needs revision.
C) Allocate additional monitoring resources to the trial.
D) Reduce the target sample size based on feedback from the sites.

4. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Investigator's Brochure
B) Data & Safety Monitoring Plan
C) Standard Operating Procedure
D) Clinical Monitoring Plan

5. A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

A) Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
B) Continue reporting temperature excursions per the pharmacy manual guidelines.
C) Return all IP and request the CRO/Sponsor to directly ship IP to participants.
D) Install an air cooler requiring regular water refills to maintain the room temperature.

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