Free ACRP ACRP-CP Exam Dumps Questions & Answers

Who is responsible for the ongoing safety evaluation of the IP?

• A.IRB/IEC
• B.Regulatory agency
• C.PI
• D.Sponsor

When assessing the monitoring needs for a study, sponsors should:

• A.Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
• B.Use central monitoring instead of conducting physical monitoring visits at sites.
• C.Permit PIs to select a monitor for their site as long as they are independent of the PI.
• D.Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.

Who must be blinded in a double-blind study in order to prevent bias?

• A.IRB/IEC
• B.Subject
• C.Data entry staff
• D.Pharmacist

All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

• A.Identifying potential study risks.
• B.Documenting all possible risk scenarios.
• C.Assessing risk based on study impact.
• D.Controlling risk by setting thresholds of risk acceptability.

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.Report the AE to the sponsor.
• C.Administer rescue medication.
• D.Call the medical monitor.