1|Page
ACRP CP CERTIFICATION EXAM NEWEST 2025/2026
COMPLETE ALL 250 QUESTIONS AND
100%CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |UPDATED & GRADED 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?
- ANSWER-ICF
Per ICH: an IRB/IEC must keep correspondence for at
least how long after the completion of a clinical trial? -
ANSWER-3 years
,2|Page
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? - 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 - ANSWER-validation, accuracy,
reliability, and completeness.
,3|Page
When should a research study involving human subjects
be registered in a publicly accessible database? -
ANSWER-Before recruiting the first subject
An unconscious adult subject was enrolled in a study after
obtaining consent from an LAR: and protocol therapy was
initiated. The subject showed significant improvement in
his clinical condition: and regained consciousness. The
Investigator should inform the subject about the study and
- ANSWER-obtain consent from the subject for the study.
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? - ANSWER-The
sponsor's files
, 4|Page
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 - ANSWER-a signed
clinical trial agreement between the site and sponsor is in
place.
In a multi-arm: randomized clinical trial: one arm of the
protocol was terminated due to an increased risk of breast
cancer in the subjects. Who is responsible for providing a
written report to the IRB/IEC? - ANSWER-PI
Part of a sponsor's responsibility pertaining to electronic
trial data handling is to maintain an audit trail: data trail:
and edit trail. Which entity is primarily charged with
ACRP CP CERTIFICATION EXAM NEWEST 2025/2026
COMPLETE ALL 250 QUESTIONS AND
100%CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |UPDATED & GRADED 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?
- ANSWER-ICF
Per ICH: an IRB/IEC must keep correspondence for at
least how long after the completion of a clinical trial? -
ANSWER-3 years
,2|Page
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? - 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 - ANSWER-validation, accuracy,
reliability, and completeness.
,3|Page
When should a research study involving human subjects
be registered in a publicly accessible database? -
ANSWER-Before recruiting the first subject
An unconscious adult subject was enrolled in a study after
obtaining consent from an LAR: and protocol therapy was
initiated. The subject showed significant improvement in
his clinical condition: and regained consciousness. The
Investigator should inform the subject about the study and
- ANSWER-obtain consent from the subject for the study.
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? - ANSWER-The
sponsor's files
, 4|Page
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 - ANSWER-a signed
clinical trial agreement between the site and sponsor is in
place.
In a multi-arm: randomized clinical trial: one arm of the
protocol was terminated due to an increased risk of breast
cancer in the subjects. Who is responsible for providing a
written report to the IRB/IEC? - ANSWER-PI
Part of a sponsor's responsibility pertaining to electronic
trial data handling is to maintain an audit trail: data trail:
and edit trail. Which entity is primarily charged with
