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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Placebo-controlled
B) Blinding
C) Privacy controls
D) Randomization

2. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A) 71%
B) 66%
C) 80%
D) 77%

3. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A) 8 calendar days
B) 7 calendar days
C) 15 calendar days
D) 30 calendar days

4. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The list of comparable technology solutions was not included.
B) The number of unique eCRF templates was not specified.
C) The number of users with access was not defined.
D) The frequency of data backup was not defined.

5. The investigator/institution should permit:

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

Solutions: