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ACRP Certified Professional Sample Questions:

1. Who determines the age of assent for pediatric studies?

A) Parent
B) PI
C) Sponsor
D) IRB/IEC

2. After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

A) Submit the diary to the sponsor for approval.
B) Submit the diary to the IRB/IEC for approval.
C) No approval is necessary: give the diary to each subject.
D) Submit the diary to the regulatory authority for approval.

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

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

4. A root cause analysis should be:

A) Written by the investigator.
B) Specific to a clinical trial.
C) Validated before use in a CAPA.
D) Focused on issues of non-compliance.

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

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

Solutions: