ACRP ACRP-CP : ACRP Certified Professional Exam

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ACRP Certified Professional Sample Questions:

1. 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

2. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A) Investigators participating in the trial.
B) Executive board members.
C) Regulatory authority expert advisors.
D) Independent qualified individuals.

3. What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

A) Inspection
B) Routine monitoring
C) Audit
D) Site qualification

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

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

5. Who is responsible for submitting a protocol amendment to the IRB/IEC?

A) Sponsor
B) CRA
C) Investigator
D) CRC

Solutions: