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ACRP Certified Professional Sample Questions:

1. The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:

A) Safeguard the rights, safety, and well-being of all potential subjects.
B) Review the content for ethically or morally sensitive issues.
C) Confirm subjects receive the appropriate reimbursement.
D) Assure the ads do not impinge on confidentiality agreements.

2. An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A) Study sponsor
B) Regulatory authority
C) Investigator at each site
D) Original reporting investigator

3. 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) PD affected participant recruitment.
C) Participant verbally agreed to the PD.
D) PD affected participant safety.

4. In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

A) A total of five members.
B) One member who is independent of the institution/trial site.
C) One member whose primary area of interest is in the same scientific area.
D) One member of the site's QA group.

5. A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A) After the original planned data collection is completed
B) When the need for the additional data is discovered
C) After the protocol amendment is approved by the IRB/IEC
D) As soon as the protocol amendment is submitted to the IRB/IEC

Solutions: