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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Study Operations | - Study conduct and oversight - Study planning and initiation |
| Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
| Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
| Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
ACRP Certified Professional Sample Questions:
1. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?
A) Report a protocol deviation to the IRB/IEC.
B) Notify the sponsor.
C) Call the participant to return for an unscheduled visit.
D) Notify the PI.
2. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?
A) Protocol, informed consent, and clinical trial agreement
B) IB, site coordinator CVs, and information about payments and compensation available to subjects
C) Protocol, site coordinator CVs, and clinical trial agreement
D) Protocol, IB, and information about payments and compensation available to subjects
3. What would a sponsor use to implement and maintain quality in a study?
A) Standard operating procedures
B) Statistical analysis plan
C) Protocol signature pages
D) Clinical trial agreement
4. The investigator/institution should permit:
A) Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
B) Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
C) Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
D) Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
5. Who determines the age of assent for pediatric studies?
A) Sponsor
B) PI
C) IRB/IEC
D) Parent
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: D | Question # 3 Answer: A | Question # 4 Answer: C | Question # 5 Answer: C |
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