ACRP ACRP-CP Actual Free Exam Questions & Community Discussion

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 monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

Who determines the age of assent for pediatric studies?

A root cause analysis should be:

The inclusion and exclusion criteria are in place so all subjects are:

SAEs must be reported immediately by the site to the:

Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?