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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

1. IP is dispensed to all subjects who:

A) Need IP for their medical condition.
B) Consented for the trial.
C) Are eligible to receive it in the trial.
D) Screened for the trial.


2. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

A) Locate a translator and have them work with the person.
B) Get an impartial witness involved in consenting this person.
C) There are no circumstances under which this person can be enrolled.
D) Have the Principal Investigator consent the person.


3. After the site qualification visit report has been finalized, it must be:

A) Included in the PI's regulatory file.
B) Kept in the CRO/sponsor's trial master file.
C) Stored in the sponsor's budgets and contracts file.
D) Sent to the IRB/IEC for review and approval.


4. An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A) Original reporting investigator
B) Regulatory authority
C) Study sponsor
D) Investigator at each site


5. Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

A) Develop a plan that describes the monitoring approach for a clinical study.
B) Conduct annual reviews of the protocol and accompanying study documents.
C) Ensure there is an accompanying written record that describes the consent process.
D) Ensure submission of a data management plan to the regulatory authorities.


Solutions:

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

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