ACRP Certified Professional : ACRP-CP Exam

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. 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.

2. The sponsor should supply a PI with the IP after:

A) Approval of protocol by the sponsor.
B) Approval of protocol by the PI.
C) Approval/favorable opinion from IRB/IEC and regulatory authority.
D) Submission of documents to IRB/IEC and regulatory authority for review.

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

4. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A) Draft a CAPA plan
B) Establish a DSMB/IDMC
C) Conduct routine investigators' meetings
D) Develop a monitoring plan

5. The investigator/institution should permit:

A) Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
B) Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
C) Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
D) Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.

Solutions: