ACRP-PM Exam Questions and Answers
with Verified Solutions | Latest Updated
2026
What is vendor oversight in Vendor oversight involves ensuring
clinical research project external partners (e.g., CROs, labs,
management? technology providers) meet
contractual, regulatory, and quality
obligations. It includes ongoing
communication, performance
tracking, and documentation of
compliance.
Scenario: A central lab vendor Begin with direct communication to
consistently misses data identify root causes. Document the
upload deadlines. What is the issue, escalate if needed per
first action you should take as escalation plan, and initiate a
PM? Corrective and Preventive Action
(CAPA) process if quality or
compliance are affected.
What should be included in a Scope of work, deliverables,
vendor management plan? timelines, communication plan,
performance metrics, escalation
paths, and documentation
requirements to ensure
accountability and oversight.
What is CAPA? Corrective and Preventive Action
(CAPA) is a systematic approach to
identify, correct, and prevent
, recurrence of issues or
noncompliance within a study or
operational process.
Scenario: You discover Investigate the source of error,
repeated data entry errors document findings, issue a CAPA,
from a site. How should you retrain personnel if needed, and
respond? verify effectiveness of the corrective
measures before closure.
What is the purpose of an An escalation plan defines
escalation plan? thresholds for issue severity and the
appropriate reporting route to
ensure timely resolution and
sponsor/stakeholder awareness.
What is a delegation of duties A log that documents study-related
log? tasks assigned to qualified
personnel, confirming roles and
responsibilities are defined and
traceable per GCP requirements.
Scenario: A site coordinator Review whether the task was within
performs a task not listed in scope and training. Update the
the delegation log. What delegation log as needed and
should you do? document retraining or corrective
action to maintain compliance.
What factors should a PM Screening rates, enrollment pace,
monitor in recruitment site activation timelines, screen
progress? failures, and subject retention.
Trends should be compared to the
recruitment plan to identify delays.
with Verified Solutions | Latest Updated
2026
What is vendor oversight in Vendor oversight involves ensuring
clinical research project external partners (e.g., CROs, labs,
management? technology providers) meet
contractual, regulatory, and quality
obligations. It includes ongoing
communication, performance
tracking, and documentation of
compliance.
Scenario: A central lab vendor Begin with direct communication to
consistently misses data identify root causes. Document the
upload deadlines. What is the issue, escalate if needed per
first action you should take as escalation plan, and initiate a
PM? Corrective and Preventive Action
(CAPA) process if quality or
compliance are affected.
What should be included in a Scope of work, deliverables,
vendor management plan? timelines, communication plan,
performance metrics, escalation
paths, and documentation
requirements to ensure
accountability and oversight.
What is CAPA? Corrective and Preventive Action
(CAPA) is a systematic approach to
identify, correct, and prevent
, recurrence of issues or
noncompliance within a study or
operational process.
Scenario: You discover Investigate the source of error,
repeated data entry errors document findings, issue a CAPA,
from a site. How should you retrain personnel if needed, and
respond? verify effectiveness of the corrective
measures before closure.
What is the purpose of an An escalation plan defines
escalation plan? thresholds for issue severity and the
appropriate reporting route to
ensure timely resolution and
sponsor/stakeholder awareness.
What is a delegation of duties A log that documents study-related
log? tasks assigned to qualified
personnel, confirming roles and
responsibilities are defined and
traceable per GCP requirements.
Scenario: A site coordinator Review whether the task was within
performs a task not listed in scope and training. Update the
the delegation log. What delegation log as needed and
should you do? document retraining or corrective
action to maintain compliance.
What factors should a PM Screening rates, enrollment pace,
monitor in recruitment site activation timelines, screen
progress? failures, and subject retention.
Trends should be compared to the
recruitment plan to identify delays.
