ACRP ACRP-CP - ACRP Certified Professional Exam

ACRP ACRP-CP Actual PDF
  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 16, 2026
  • Q & A: 127 Questions and Answers
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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Clinical Study Operations15%- Project management
  • 1. Vendor and stakeholder management
  • 2. Timeline and budget management
- Site management
  • 1. Site personnel training and delegation
  • 2. Study documentation and record keeping
Topic 2: Professionalism and Ethical Practice15%- Professional standards
  • 1. Confidentiality and conflict of interest
  • 2. Role responsibilities and boundaries
- Continuous improvement
  • 1. Professional development and education
  • 2. Quality assurance and process improvement
Topic 3: Data Management and Informatics17%- Data reporting
  • 1. Database lock and data transfer
  • 2. Data integrity and security
- Data collection
  • 1. Electronic data capture systems
  • 2. Case report form design and completion
- Data quality control
  • 1. Query management and resolution
  • 2. Data validation and cleaning
Topic 4: Ethical and Participant Safety Considerations19%- Ethical principles
  • 1. Human subject protections and privacy
  • 2. Clinical equipoise and therapeutic misconception
- Clinical care and management of research participants
  • 1. Standard of care vs protocol requirements
  • 2. Informed consent development and review
  • 3. Continuity of medical care
- Safety monitoring and reporting
  • 1. Safety information evaluation and communication
  • 2. Adverse event identification and classification
Topic 5: Study Design and Conduct17%- Study implementation
  • 1. Study monitoring and oversight
  • 2. Investigational product management
  • 3. Site selection and activation
- Study planning
  • 1. Protocol development and amendments
  • 2. Study population and eligibility criteria
  • 3. Sample size and statistical considerations
Topic 6: Regulatory and Compliance Requirements17%- ICH Guidelines
  • 1. E11 Pediatric Trials
  • 2. E2A Expedited Reporting
  • 3. E9 Statistical Principles
  • 4. E6(R2)/E6(R3) Good Clinical Practice
  • 5. E8 General Considerations for Clinical Trials
- International standards
  • 1. Declaration of Helsinki
- Compliance procedures
  • 1. Audits and inspections
  • 2. Regulatory submissions and approvals

ACRP Certified Professional Sample Questions:

1. Who must be blinded in a double-blind study in order to prevent bias?

A) Pharmacist
B) IRB/IEC
C) Subject
D) Data entry staff


2. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A) 5 participants
B) 3 participants
C) 4 participants
D) 6 participants


3. The sponsor should supply a PI with the IP after:

A) Approval/favorable opinion from IRB/IEC and regulatory authority.
B) Submission of documents to IRB/IEC and regulatory authority for review.
C) Approval of protocol by the sponsor.
D) Approval of protocol by the PI.


4. The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:

A) Review the content for ethically or morally sensitive issues.
B) Safeguard the rights, safety, and well-being of all potential subjects.
C) Assure the ads do not impinge on confidentiality agreements.
D) Confirm subjects receive the appropriate reimbursement.


5. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Administer rescue medication.
B) Call the medical monitor.
C) Consult the IB.
D) Report the AE to the sponsor.


Solutions:

Question # 1
Answer: C
Question # 2
Answer: B
Question # 3
Answer: A
Question # 4
Answer: B
Question # 5
Answer: A

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