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ACRP Certified Professional Sample Questions:

1. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A) Investigator
B) Sponsor
C) CRO
D) IRB/IEC

2. Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

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

3. A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A) The site receives approval from the medical monitor to begin enrolling.
B) A signed clinical trial agreement between the site and sponsor is in place.
C) The DSMB meets and the first DSMB meeting report has been issued.
D) The CRA has performed source document review and verification at the site.

4. SAEs must be reported immediately by the site to the:

A) IRB/IEC.
B) Sponsor.
C) DSMB/IDMC.
D) Regulatory agency.

5. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Withdraw the subject.
B) Notify the subject.
C) Notify the sponsor.
D) Notify the regulatory authority.

Solutions: