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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Topic 1: Data Management and Informatics	17%	- Data reporting 1. Data integrity and security 2. Database lock and data transfer - 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 2: Professionalism and Ethical Practice	15%	- Continuous improvement 1. Quality assurance and process improvement 2. Professional development and education - Professional standards 1. Role responsibilities and boundaries 2. Confidentiality and conflict of interest
Topic 3: Regulatory and Compliance Requirements	17%	- ICH Guidelines 1. E6(R2)/E6(R3) Good Clinical Practice 2. E8 General Considerations for Clinical Trials 3. E9 Statistical Principles 4. E11 Pediatric Trials 5. E2A Expedited Reporting - International standards 1. Declaration of Helsinki - Compliance procedures 1. Regulatory submissions and approvals 2. Audits and inspections
Topic 4: Clinical Study Operations	15%	- Project management 1. Timeline and budget management 2. Vendor and stakeholder management - Site management 1. Site personnel training and delegation 2. Study documentation and record keeping
Topic 5: Study Design and Conduct	17%	- Study implementation 1. Investigational product management 2. Study monitoring and oversight 3. Site selection and activation - Study planning 1. Study population and eligibility criteria 2. Sample size and statistical considerations 3. Protocol development and amendments
Topic 6: 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 - 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

ACRP Certified Professional Sample Questions:

1. During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

A) CRC
B) CRA
C) Sponsor
D) PI

2. Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

A) CRC
B) CRA
C) Sponsor
D) PI

3. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A) 77%
B) 80%
C) 71%
D) 66%

4. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A) No, the PI does not have the resources to perform all protocol-required procedures.
B) Yes, the PI has a sufficient patient population to take part in this study.
C) No, the PI is taking part in too many ongoing studies to participate in this study.
D) Yes, the PI can perform other imaging scans instead of the PET scans.

5. 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

Solutions:

Question # 1
Answer: D

Question # 2
Answer: D

Question # 3
Answer: A

Question # 4
Answer: A

Question # 5
Answer: B