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
,2|Page
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-
3 Years
When would an impartial witness be needed during the consent
process for an illiterate subject? - CORRECT ANSWER-To
observe the consent process
, 3|Page
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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller johnkabiru. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $29.99. You're not tied to anything after your purchase.
