ACRP-CP Certification Exam Latest Update 2025- 2026 Exam 215 Questions with 100% Verified Correct Answers Guaranteed A+
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
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
A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject as the subject was suffering from Adverse Events (AEs) like headaches and vomiting. When is a CRC allowed to do this task? - CORRECT
ANSWER: Only when the CRC is a qualified physician and has been delegated this
responsibility by the PI
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.
A CRA notices during an onsite visit that the date on IRB/IEC 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/IEC submission dates.
A CRO recently switched from paper CRF to an EDC system. The EDC system must
conform to the established requirements for - CORRECT ANSWER: validation,
accuracy, reliability, and completeness.
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A medical student is approached by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the
subject? - CORRECT ANSWER: Consenting in the presence of figure of authority
A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the
study? - CORRECT ANSWER: Consenting in the presence of figure of authority
A new study is investigating a new IND "glue" that can be used to hold skin cuts together and decrease the chance of scaring. You know children should be included because ICH E8 considers them a special population. In designing the protocol you should expect to - CORRECT ANSWER: Include children in the general plan from the beginning
A non-English speaking subject has responded to a recruitment ad to participate in a trial for treatment of her diabetes. She arrives at the site with her daughter who is fluent in English. The informed consent forms are only available in English. What actions are
compliant with GCP? - CORRECT ANSWER: Call the sponsor to request a translation
of the informed consent
A randomised controlled trial ( RCT ) that lets you carry out 2 or more treatment comparisons at the same time. while multiple factors are manipulated - CORRECT
ANSWER: Factorial Study
A research study: in which there is no intended clinical benefit to the subject: is being submitted to the IRB. What benefit information should be included in the ICF? -
CORRECT ANSWER: Wording indicating that there is no expected benefit should be
included
A research study: in which there is no intended clinical benefit to the subject: is being submitted to the IRB/IEC. What benefit information should be included in the ICF? -
CORRECT ANSWER: Wording indicating that there is no expected benefit should be
included.
A research subject's responsibilities for study participation should be described in the -
CORRECT ANSWER: ICF 2 / 3
A research subject's responsibilities for study participation should be described in the -
CORRECT ANSWER: ICF
A site is in the start up phase of an industry sponsored phase 3 trial: and has received IRB approval. The site can begin enrolling subjects after... - CORRECT ANSWER: A signed clinical trial agreement between the site and sponsor is in place.
A site is in the start-up phase of an industry-sponsored phase 3 trial: and has received IRB/IEC approval. The site can begin enrolling subjects after - CORRECT ANSWER: a signed clinical trial agreement between the site and sponsor is in place.
A site is in the start-up phase of an industry-sponsored phase 3 trial: and has received
IRB/IEC approval. When can the site begin enrolling subjects? - CORRECT ANSWER:
after a signed clinical trial agreement between the site and sponsor is in place
A site is screening potential subjects for a study looking at mild cognitive impairment.One of the inclusion criteria is a score of 25 or less on a psychometric test: a research specific tool which measures cognitive ability. Which of the following individuals can
administer the psychometric test to the potential subjects? - CORRECT ANSWER: A
research assistant who is certified to administer the psychometric test
A site is screening potential subjects for a study looking at mild cognitive impairment.One of the inclusion criteria is a score of 25 or less on a psychometric test: a research- specific tool which measures cognitive ability. Which of the following individuals can
administer the psychometric test to the potential subjects? - CORRECT ANSWER: A
research assistant who is certified to administer the psychometric test
A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study design they will use to test the efficacy of the IP? -
CORRECT ANSWER: Non-Inferiority
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