- | P a g e
ACRP CP EXAM NEWEST 2024-2025 ACTUAL
EXAM COMPLETE 100 QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |ALREADY GRADED A+
A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - CORRECT ANSWER-Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates.
In a multi arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk of cancer in subjects.Who is responsible for providing a written report to the IRB? -
CORRECT ANSWER -PI
Which of the following required elements should be included in a clinical trial protocol? - CORRECT ANSWER -Subject inclusion and exclusion criteria
- / 3
- | P a g e
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the - CORRECT ANSWER-PI and Sponsor
During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? - CORRECT ANSWER -Electronic medical record
When considering participation in a study, the investigator should determine if he... - CORRECT ANSWER -Sees enough patients who would qualify for the study
New safety information has become available from the Sponsor
about the IP being used in a clinical trial. The investigator must:
- CORRECT ANSWER -Submit a revised ICF to the IRB noting
the new safety information
Per ICH, an IRB must keep correspondence for at least how long after the completion of a clinical trial? - CORRECT ANSWER -
- Years
When would an impartial witness be needed during the consent process for an illiterate subject? - CORRECT ANSWER -To observe the consent process
- / 3
- | P a g e
A study which seeks to determine the ideal dose and regimen of
a new IP to treat hypothyroidism is considered to be: -
CORRECT ANSWER -Phase II
After completion of a study, the final trial close out monitoring report prepared by the CRA should be filed in which of the following stakeholder files? - CORRECT ANSWER -The sponsors files
A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences? - CORRECT ANSWER - ICF
When should a research study involving human subjects be registered in a publicly accessible database? - CORRECT ANSWER-Before recruiting the first subject
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - CORRECT ANSWER -The subjects legally acceptable representative
A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy simulation
- / 3