Free ACRP ACRP-CP Exam Dumps Questions & Answers

After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

• A.  No approval is necessary: give the diary to each subject.
• B.  Submit the diary to the sponsor for approval.
• C.  Submit the diary to the IRB/IEC for approval.
• D.  Submit the diary to the regulatory authority for approval.

A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

• A.  The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
• B.  The site may proceed with the destruction of the essential documents.
• C.  The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
• D.  The site should retain the essential documents longer to meet the regulatory requirements.

Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

• A.  Coordinator
• B.  Monitor
• C.  Sponsor
• D.  Investigator

When designing a clinical trial, why is it important to define the study population?

• A.  To determine the study objectives
• B.  To support the study objectives
• C.  To determine where to conduct the study
• D.  To support subject recruitment to the study

The PI should ensure that source data is:

• A.  Accurately reflected in the eCRFs.
• B.  On worksheets that are provided by the sponsor.
• C.  Kept on site for a minimum of 2 years.
• D.  Printed directly from the EMR.