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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Quality Management | - Risk management
|
| Topic 2: Professional Responsibilities | - Communication and collaboration
|
| Topic 3: Data Management and Documentation | - Clinical trial documentation
|
| Topic 4: Ethical and Participant Safety Considerations | - Human subject protection
|
| Topic 5: Clinical Trial Operations | - Study start-up activities
|
ACRP Certified Professional Sample Questions:
1. While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?
A) Submit revised ICFs to the IRB/IEC with increased compensation for participants.
B) Require participants to provide documented reason for withdrawal.
C) Meet with the site staff to understand their workflows and to review retention strategies.
D) Interview participants who have dropped out.
2. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:
A) Identifying potential study risks.
B) Controlling risk by setting thresholds of risk acceptability.
C) Documenting all possible risk scenarios.
D) Assessing risk based on study impact.
3. At a close-out visit, which document should be retained only at the site?
A) Treatment allocation
B) Subject identification code list
C) IP accountability
D) Final trial close-out monitoring report
4. Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:
A) CRA
B) Sponsor
C) CRC
D) PI
5. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?
A) All duties transferred to a CRO should be specified in writing.
B) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
C) Any trial-related duties can be documented as transferred by verbal agreement.
D) The IRB/IEC must approve the transfer of duties to a CRO.
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: C | Question # 3 Answer: B | Question # 4 Answer: D | Question # 5 Answer: A |



