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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
| Study Operations | - Study planning and initiation - Study conduct and oversight |
| Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
| Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
ACRP Certified Professional Sample Questions:
1. What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?
A) Site qualification
B) Routine monitoring
C) Audit
D) Inspection
2. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?
A) Length of time to receive the approved trial device
B) Location of stored trial records
C) Information to be included in the advertising flyer
D) Availability of qualified staff to conduct the trial
3. Centralized monitoring can:
A) Identify IP accountability and storage issues.
B) Indicate the need to send monitors to perform onsite visits.
C) Confirm why sites are deviating from the protocol.
D) Enable appropriate stratification of subject enrollment.
4. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:
A) 8 calendar days
B) 30 calendar days
C) 15 calendar days
D) 7 calendar days
5. A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?
A) As soon as the protocol amendment is submitted to the IRB/IEC
B) After the original planned data collection is completed
C) When the need for the additional data is discovered
D) After the protocol amendment is approved by the IRB/IEC
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: D | Question # 3 Answer: B | Question # 4 Answer: C | Question # 5 Answer: D |



