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ACRP Certified Professional Sample Questions:

1. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, IB, and information about payments and compensation available to subjects
B) Protocol, site coordinator CVs, and clinical trial agreement
C) Protocol, informed consent, and clinical trial agreement
D) IB, site coordinator CVs, and information about payments and compensation available to subjects

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

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

3. While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

A) Sponsor
B) CRC
C) PI
D) CRO

4. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A) Sponsor
B) Applicable site SOPs
C) Applicable regulatory authorities
D) PI

5. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) Monitor
B) Sponsor
C) Data Manager
D) QA Department

Solutions: