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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
| Topic 2: Study Operations | - Study conduct and oversight - Study planning and initiation |
| Topic 3: Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Topic 4: Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
| Topic 5: Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
ACRP Certified Professional Sample Questions:
1. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?
A) Crossover
B) Parallel Group
C) Group sequential
D) Factorial
2. 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
3. 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) Location of stored trial records
B) Information to be included in the advertising flyer
C) Availability of qualified staff to conduct the trial
D) Length of time to receive the approved trial device
4. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?
A) Yes, the PI can perform other imaging scans instead of the PET scans.
B) No, the PI does not have the resources to perform all protocol-required procedures.
C) Yes, the PI has a sufficient patient population to take part in this study.
D) No, the PI is taking part in too many ongoing studies to participate in this study.
5. A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:
A) Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.
B) Reject the alternative hypothesis that the drug has no effect on cholesterol levels.
C) Reject the null hypothesis that the drug has no effect on cholesterol levels.
D) Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: B | Question # 5 Answer: C |
