Free ACRP ACRP-CP Exam Dumps Questions & Answers

Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

• A.  Perform a periodic review to see if the quality methods are effective and relevant.
• B.  Identify critical processes and data during protocol development.
• C.  Determine the quality tolerance limits for data transcription errors.
• D.  Train the research coordinator on the required study assessments schedule.

Who determines the age of assent for pediatric studies?

• A.  PI
• B.  Sponsor
• C.  IRB/IEC
• D.  Parent

The sponsor should supply a PI with the IP after:

• A.  Approval/favorable opinion from IRB/IEC and regulatory authority.
• B.  Submission of documents to IRB/IEC and regulatory authority for review.
• C.  Approval of protocol by the PI.
• D.  Approval of protocol by the sponsor.

Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

• A.  Project feasibility considerations
• B.  PI roles and responsibilities
• C.  Emerging animal toxicological and clinical data
• D.  Sample collection storage, disposal, and shipment requirements

A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

• A.  Phase III
• B.  Phase II
• C.  Phase I
• D.  Phase IV