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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Data Management and Informatics	17%	- 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
Clinical Study Operations	15%	- Project management 1. Vendor and stakeholder management 2. Timeline and budget management - Site management 1. Study documentation and record keeping 2. Site personnel training and delegation
Regulatory and Compliance Requirements	17%	- Compliance procedures 1. Regulatory submissions and approvals 2. Audits and inspections - ICH Guidelines 1. E8 General Considerations for Clinical Trials 2. E2A Expedited Reporting 3. E11 Pediatric Trials 4. E6(R2)/E6(R3) Good Clinical Practice 5. E9 Statistical Principles - International standards 1. Declaration of Helsinki
Professionalism and Ethical Practice	15%	- Continuous improvement 1. Professional development and education 2. Quality assurance and process improvement - Professional standards 1. Role responsibilities and boundaries 2. Confidentiality and conflict of interest
Ethical and Participant Safety Considerations	19%	- Clinical care and management of research participants 1. Informed consent development and review 2. Continuity of medical care 3. Standard of care vs protocol requirements - Ethical principles 1. Human subject protections and privacy 2. Clinical equipoise and therapeutic misconception - Safety monitoring and reporting 1. Adverse event identification and classification 2. Safety information evaluation and communication
Study Design and Conduct	17%	- Study planning 1. Study population and eligibility criteria 2. Sample size and statistical considerations 3. Protocol development and amendments - Study implementation 1. Study monitoring and oversight 2. Investigational product management 3. Site selection and activation

ACRP Certified Professional Sample Questions:

Question 1

An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
B. Add the risk of infection to the ICF and submit to the IRB/IEC for review.
C. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
D. Update the IB to add the risk of infection and submit to the sponsor for approval.

Question 2

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

Question 3

A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

A. A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
B. A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
C. A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
D. A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population

Question 4

In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A. PI
B. IRB/IEC
C. CRA
D. CRC

Question 5

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. Blinding
C. Randomization
D. Placebo-controlled

Solutions:

Question 1
Answer: C

Question 2
Answer: D

Question 3
Answer: B

Question 4
Answer: A

Question 5
Answer: C