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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| 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 |
| Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
| Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Study Operations | - Study conduct and oversight - Study planning and initiation |
ACRP Certified Professional Sample Questions:
1. A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?
A) Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
B) Report this incident immediately to the sponsor and leave the treatment decision to them.
C) Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
D) Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
2. A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?
A) Active control
B) No treatment
C) Alternate dose
D) Placebo
3. 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) Inspection
B) Site qualification
C) Routine monitoring
D) Audit
4. The composition of an IDMC/DSMB should include which one of the following?
A) A lead PI for the study
B) A member from the IRB/IEC
C) A clinical scientist who is knowledgeable in the appropriate discipline
D) A sponsor representative who is knowledgeable about the study's unblinded information
5. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?
A) Sponsor
B) Monitor
C) QA Department
D) Data Manager
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: D | Question # 3 Answer: D | Question # 4 Answer: C | Question # 5 Answer: B |
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