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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Professionalism and Ethical Practice	15%	- Professional standards 1. Confidentiality and conflict of interest 2. Role responsibilities and boundaries - Continuous improvement 1. Quality assurance and process improvement 2. Professional development and education
Study Design and Conduct	17%	- Study planning 1. Protocol development and amendments 2. Study population and eligibility criteria 3. Sample size and statistical considerations - Study implementation 1. Investigational product management 2. Study monitoring and oversight 3. Site selection and activation
Data Management and Informatics	17%	- Data collection 1. Electronic data capture systems 2. Case report form design and completion - Data quality control 1. Data validation and cleaning 2. Query management and resolution - Data reporting 1. Database lock and data transfer 2. Data integrity and security
Regulatory and Compliance Requirements	17%	- Compliance procedures 1. Audits and inspections 2. Regulatory submissions and approvals - International standards 1. Declaration of Helsinki - 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
Clinical Study Operations	15%	- 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
Ethical and Participant Safety Considerations	19%	- Safety monitoring and reporting 1. Adverse event identification and classification 2. Safety information evaluation and communication - Ethical principles 1. Clinical equipoise and therapeutic misconception 2. Human subject protections and privacy - 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

ACRP Certified Professional Sample Questions:

1. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Privacy controls
B) Placebo-controlled
C) Randomization
D) Blinding

2. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The PI should amend the medical chart.
B) The CRC should amend the medical chart.
C) The CRC should write a note to file.
D) The PI should notify the monitor.

3. Who on the local site research study team is accountable for the unblinding documentation of IP?

A) Pharmacist
B) PI
C) CRC
D) Regulatory manager

4. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) Source document.
B) CRF.
C) Worksheet.
D) PRO.

5. When designing a clinical trial, why is it important to define the study population?

A) To support the study objectives
B) To support subject recruitment to the study
C) To determine where to conduct the study
D) To determine the study objectives

Solutions:

Question # 1
Answer: C

Question # 2
Answer: A

Question # 3
Answer: B

Question # 4
Answer: B

Question # 5
Answer: A