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ACRP Certified Professional Sample Questions:
1. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?
A) Verify subject eligibility
B) Ship/receive IP
C) Obtain IRB/IEC approval
D) Schedule a site initiation visit
2. The sponsor should supply a PI with the IP after:
A) Approval of protocol by the PI.
B) Submission of documents to IRB/IEC and regulatory authority for review.
C) Approval/favorable opinion from IRB/IEC and regulatory authority.
D) Approval of protocol by the sponsor.
3. Who must be blinded in a double-blind study in order to prevent bias?
A) Pharmacist
B) Data entry staff
C) IRB/IEC
D) Subject
4. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?
A) Sample collection storage, disposal, and shipment requirements
B) PI roles and responsibilities
C) Project feasibility considerations
D) Emerging animal toxicological and clinical data
5. When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:
A) Sponsor approved the PD.
B) Participant verbally agreed to the PD.
C) PD affected participant recruitment.
D) PD affected participant safety.
Solutions:
Question # 1 Answer: C | Question # 2 Answer: C | Question # 3 Answer: D | Question # 4 Answer: D | Question # 5 Answer: D |