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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) DSMB/IDMC
B) Sponsor
C) Health authority
D) Investigator

2. Who on the local site research study team is accountable for the unblinding documentation of IP?

A) Pharmacist
B) PI
C) CRC
D) Regulatory manager

3. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Coordinator
B) Sponsor
C) Monitor
D) Investigator

4. After the site qualification visit report has been finalized, it must be:

A) Stored in the sponsor's budgets and contracts file.
B) Included in the PI's regulatory file.
C) Sent to the IRB/IEC for review and approval.
D) Kept in the CRO/sponsor's trial master file.

5. The inclusion and exclusion criteria are in place so all subjects are:

A) Healthy and willing to complete the clinical trial.
B) Medically appropriate and protected from ethical vulnerability.
C) Ethically vulnerable and patients with the disease under study.
D) Patients with the disease under study and will not have any adverse events.

Solutions: