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ACRP Certified Professional Sample Questions:

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

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

2. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Consult the IB.
B) Call the medical monitor.
C) Administer rescue medication.
D) Report the AE to the sponsor.

3. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

A) Get an impartial witness involved in consenting this person.
B) Locate a translator and have them work with the person.
C) Have the Principal Investigator consent the person.
D) There are no circumstances under which this person can be enrolled.

4. 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) No treatment
B) Placebo
C) Alternate dose
D) Active control

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

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

Solutions: