Online Access Free ACRP-CP Exam Questions

What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

• A.Site qualification
• B.Routine monitoring
• C.Audit
• D.Inspection

An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

• A.Study sponsor
• B.Investigator at each site
• C.Original reporting investigator
• D.Regulatory authority

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

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

A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

• A.This needs to be reported to the patient's primary care physician.
• B.This needs to be reported to the regulatory authorities within 10 business days.
• C.This qualifies for expedited reporting to the sponsor.
• D.This qualifies for prompt reporting to the IRB/IEC within 15 business days.

AEs that occur between study visits of a clinical trial should be evaluated by the:

• A.Principal Investigator
• B.Subject's primary care physician
• C.Medical monitor
• D.Study pharmacovigilance physician