Free ACRP ACRP-CP Exam Dumps Questions & Answers

The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

• A.  Schedule participant for early termination visit.
• B.  Inform the monitor of the termination of the study.
• C.  Inform participant and assure proper care is provided.
• D.  Inform the IRB/IEC of the study closure.

A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

• A.  Yes, the PI can perform other imaging scans instead of the PET scans.
• B.  No, the PI does not have the resources to perform all protocol-required procedures.
• C.  No, the PI is taking part in too many ongoing studies to participate in this study.
• D.  Yes, the PI has a sufficient patient population to take part in this study.

Which of the following statements is TRUE about an EDC system?

• A.  A separate workstation should be made available for the monitor.
• B.  IRB/IEC approval is required before the use of the computerized system.
• C.  There should be an audit trail to track data entries, deletions, and changes.
• D.  The eCRF should be an exact page-by-page replica of the paper CRF.

All of the following are examples of what monitors review EXCEPT:

• A.  Documentation in the participant's medical record of study drug administration.
• B.  Potential patient medical records for eligibility prior to the informed consent process.
• C.  Regulatory binder which includes copies of current certifications for all laboratories.
• D.  The signed ICF retained in the participant's study file.

In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

• A.  Investigator
• B.  CRC
• C.  CRA
• D.  Sponsor