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ACRP-PM (ACRP Project Manager Subspecialty)
Exam ACTUAL QUESTIONS AND ANSWERS LATEST
UPDATE THIS YEAR
✅ ACRP-PM EXAM COVERAGE (SUMMARIZED POINT FORM)
1. Ethical and Participant Safety Considerations (25%)
o Informed consent form (ICF) development/review
o Human subject protections and privacy (national/international regulations)
o Recruitment and retention strategies
o Safety monitoring (SAEs, SUSARs, DSMB)
o Conflict-of-interest (COI) identification and management
o Vulnerable populations
2. Regulatory Affairs (10%)
o Applicable regulatory requirements for investigational product/device
o Budgetary and logistical aspects of product accountability
o Regulatory reporting (pre-/post-approval, safety, grant)
o Audit/inspection preparation, participation, documentation, follow-up
o Clinical trial registries
o Fraud/misconduct identification and management
o Key milestones (interim analysis, DSMB review)
3. Clinical Trial Operations (25%)
o Evaluation of trial conduct against protocol, monitoring plan, data management plan
o Participation in audits/inspections (prepare, support, respond)
o Coordination/oversight of protocol, amendments, approvals (IRB/IEC, sponsor,
regulatory authority)
o Protocol and study training (site initiation visit, investigator meeting)
o Issue identification and management (deviation, CAPA)
4. Study Management (weighted most heavily in some outlines)
o Site selection, feasibility, activation
o Performance management (metrics, KPIs)
o Resource allocation and budget management
o Vendor management
o Contract and agreement negotiation
5. Scientific Concepts & Research Design
o Protocol development and interpretation
o Biostatistics fundamentals (sample size, endpoints)
o Study methodology (randomization, blinding, controls)
6. Business Management, Leadership & Professionalism (15%)
o Conflict resolution and team leadership
o Vendor/contractor management
o Negotiation skills
o Budgeting and financial oversight
o Professionalism and ethical decision-making
7. Data Management (5%)
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o CRF design and EDC systems
o Data quality assurance and query resolution
8. Integrative Case Scenarios
o Cross-domain application of knowledge
Key Reference: ICH E6(R3) Good Clinical Practice (effective July 15, 2026).
250 RANDOM SCENARIO-BASED MCQs (with Answers & Rationales)
QUESTION 1:
A clinical research project manager (PM) is developing a risk management plan for a Phase III trial. What
is the FIRST step in the risk management process?
A) Implement a corrective action plan
B) Identify potential risks to the project
C) Transfer risk to a third-party vendor
D) Calculate the risk priority number for each risk
Answer: B – The risk management process begins with identification; you cannot manage risks you have
not identified.
QUESTION 2:
During an internal audit, the PM discovers that multiple sites have enrolled participants without
obtaining proper informed consent. Which action is the highest priority?
A) Terminate the sites immediately
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B) Report the findings to the IRB and regulatory authorities as required
C) Retrain all site staff on the informed consent process
D) Revise the protocol to remove the consent requirement
Answer: B – Failure to obtain informed consent is a serious violation of human subject protections and
must be reported promptly to the IRB and, if applicable, regulatory authorities.
QUESTION 3:
A new clinical trial has been approved to begin. What is the primary purpose of a Site Initiation Visit
(SIV)?
A) To sign the contract with the site
B) To train site staff on the protocol and study procedures
C) To collect the first participant‘s data
D) To submit the study to the FDA
Answer: B – The SIV is conducted to ensure site staff understand the protocol, study procedures, and
Good Clinical Practice (GCP) requirements before enrollment begins.
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QUESTION 4:
A PM is reviewing a Clinical Study Report (CSR). Which section should be reviewed FIRST to understand
the overall conclusions of the trial?
A) Methodology
B) Results
C) Discussion
D) Synopsis/Executive Summary
Answer: D – The synopsis or executive summary provides a high-level overview of the trial, including its
objectives, methods, key results, and conclusions.
QUESTION 5:
A study monitor reports that a site has consistently failed to report serious adverse events (SAEs) within
the required timeframe. What is the PM‘s most appropriate initial action?
A) Terminate the site immediately
B) Issue a corrective action plan (CAPA) with specific deadlines
C) Ignore the issue until the next monitoring visit
D) Report the site to the FDA without prior notice
ACRP-PM (ACRP Project Manager Subspecialty)
Exam ACTUAL QUESTIONS AND ANSWERS LATEST
UPDATE THIS YEAR
✅ ACRP-PM EXAM COVERAGE (SUMMARIZED POINT FORM)
1. Ethical and Participant Safety Considerations (25%)
o Informed consent form (ICF) development/review
o Human subject protections and privacy (national/international regulations)
o Recruitment and retention strategies
o Safety monitoring (SAEs, SUSARs, DSMB)
o Conflict-of-interest (COI) identification and management
o Vulnerable populations
2. Regulatory Affairs (10%)
o Applicable regulatory requirements for investigational product/device
o Budgetary and logistical aspects of product accountability
o Regulatory reporting (pre-/post-approval, safety, grant)
o Audit/inspection preparation, participation, documentation, follow-up
o Clinical trial registries
o Fraud/misconduct identification and management
o Key milestones (interim analysis, DSMB review)
3. Clinical Trial Operations (25%)
o Evaluation of trial conduct against protocol, monitoring plan, data management plan
o Participation in audits/inspections (prepare, support, respond)
o Coordination/oversight of protocol, amendments, approvals (IRB/IEC, sponsor,
regulatory authority)
o Protocol and study training (site initiation visit, investigator meeting)
o Issue identification and management (deviation, CAPA)
4. Study Management (weighted most heavily in some outlines)
o Site selection, feasibility, activation
o Performance management (metrics, KPIs)
o Resource allocation and budget management
o Vendor management
o Contract and agreement negotiation
5. Scientific Concepts & Research Design
o Protocol development and interpretation
o Biostatistics fundamentals (sample size, endpoints)
o Study methodology (randomization, blinding, controls)
6. Business Management, Leadership & Professionalism (15%)
o Conflict resolution and team leadership
o Vendor/contractor management
o Negotiation skills
o Budgeting and financial oversight
o Professionalism and ethical decision-making
7. Data Management (5%)
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o CRF design and EDC systems
o Data quality assurance and query resolution
8. Integrative Case Scenarios
o Cross-domain application of knowledge
Key Reference: ICH E6(R3) Good Clinical Practice (effective July 15, 2026).
250 RANDOM SCENARIO-BASED MCQs (with Answers & Rationales)
QUESTION 1:
A clinical research project manager (PM) is developing a risk management plan for a Phase III trial. What
is the FIRST step in the risk management process?
A) Implement a corrective action plan
B) Identify potential risks to the project
C) Transfer risk to a third-party vendor
D) Calculate the risk priority number for each risk
Answer: B – The risk management process begins with identification; you cannot manage risks you have
not identified.
QUESTION 2:
During an internal audit, the PM discovers that multiple sites have enrolled participants without
obtaining proper informed consent. Which action is the highest priority?
A) Terminate the sites immediately
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B) Report the findings to the IRB and regulatory authorities as required
C) Retrain all site staff on the informed consent process
D) Revise the protocol to remove the consent requirement
Answer: B – Failure to obtain informed consent is a serious violation of human subject protections and
must be reported promptly to the IRB and, if applicable, regulatory authorities.
QUESTION 3:
A new clinical trial has been approved to begin. What is the primary purpose of a Site Initiation Visit
(SIV)?
A) To sign the contract with the site
B) To train site staff on the protocol and study procedures
C) To collect the first participant‘s data
D) To submit the study to the FDA
Answer: B – The SIV is conducted to ensure site staff understand the protocol, study procedures, and
Good Clinical Practice (GCP) requirements before enrollment begins.
, Page 4 of 136
QUESTION 4:
A PM is reviewing a Clinical Study Report (CSR). Which section should be reviewed FIRST to understand
the overall conclusions of the trial?
A) Methodology
B) Results
C) Discussion
D) Synopsis/Executive Summary
Answer: D – The synopsis or executive summary provides a high-level overview of the trial, including its
objectives, methods, key results, and conclusions.
QUESTION 5:
A study monitor reports that a site has consistently failed to report serious adverse events (SAEs) within
the required timeframe. What is the PM‘s most appropriate initial action?
A) Terminate the site immediately
B) Issue a corrective action plan (CAPA) with specific deadlines
C) Ignore the issue until the next monitoring visit
D) Report the site to the FDA without prior notice
