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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Study Operations | - Study conduct and oversight - Study planning and initiation |
| Topic 2: Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Topic 3: Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
| Topic 4: Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Topic 5: Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
ACRP Certified Professional Sample Questions:
1. In a quality management system, in which category do risk reduction activities belong?
A) Risk Control
B) Risk Communication
C) Risk Evaluation
D) Risk Review
2. Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?
A) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
B) The CRC is responsible for identifying the relationship of an SAE to the IP.
C) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
D) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
3. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:
A) Documenting all possible risk scenarios.
B) Assessing risk based on study impact.
C) Identifying potential study risks.
D) Controlling risk by setting thresholds of risk acceptability.
4. The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:
A) Safeguard the rights, safety, and well-being of all potential subjects.
B) Assure the ads do not impinge on confidentiality agreements.
C) Confirm subjects receive the appropriate reimbursement.
D) Review the content for ethically or morally sensitive issues.
5. Source data/documentation should be:
A) Attributable, legible, correct, original, accurate, and complete.
B) Attributable, legible, correct, original, accurate, and clear.
C) Attributable, legible, contemporaneous, original, accurate, and clear.
D) Attributable, legible, contemporaneous, original, accurate, and complete.
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: C | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: D |




