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ACRP ACRP-CP Actual Tests : ACRP Certified Professional Exam
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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Topic 2: Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
| Topic 3: Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Topic 4: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 5: Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
ACRP Certified Professional Sample Questions:
When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:
- A. PD affected participant recruitment.
- B. PD affected participant safety.
- C. Sponsor approved the PD.
- D. Participant verbally agreed to the PD.
Correct Answer: B 🗳️
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A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?
- A. Establish a DSMB/IDMC
- B. Draft a CAPA plan
- C. Develop a monitoring plan
- D. Conduct routine investigators' meetings
Correct Answer: A 🗳️
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A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?
- A. Protocol
- B. IB
- C. ICF
- D. Package insert
Correct Answer: C 🗳️
Explanation: Only visible for Actual4test members. You can sign-up / login (it's free).
Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?
- A. CRA
- B. Data Manager
- C. CRO
- D. Sponsor
Correct Answer: D 🗳️
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The inclusion and exclusion criteria are in place so all subjects are:
- A. Medically appropriate and protected from ethical vulnerability.
- B. Ethically vulnerable and patients with the disease under study.
- C. Patients with the disease under study and will not have any adverse events.
- D. Healthy and willing to complete the clinical trial.
Correct Answer: A 🗳️
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