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ACRP Certified Professional Sample Questions:

1. A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

A) Active control
B) No treatment
C) Placebo
D) Alternate dose

2. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B) A monitoring report that identifies deviation from the approved protocol.
C) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D) Training records of site personnel on study protocol, and their study-related duties and functions.

3. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A member of the research team
B) A family member
C) A legally acceptable representative
D) A witness

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

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

5. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) Sponsor
B) CRC
C) Regulatory Agency
D) PI

Solutions: