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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Study Operations | - Study planning and initiation - Study conduct and oversight |
| Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
| Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
ACRP Certified Professional Sample Questions:
1. 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) Information to be included in the advertising flyer
B) Availability of qualified staff to conduct the trial
C) Location of stored trial records
D) Length of time to receive the approved trial device
2. The inclusion and exclusion criteria are in place so all subjects are:
A) Healthy and willing to complete the clinical trial.
B) Ethically vulnerable and patients with the disease under study.
C) Medically appropriate and protected from ethical vulnerability.
D) Patients with the disease under study and will not have any adverse events.
3. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
A) Randomization
B) Placebo-controlled
C) Blinding
D) Privacy controls
4. The composition of an IDMC/DSMB should include which one of the following?
A) A clinical scientist who is knowledgeable in the appropriate discipline
B) A lead PI for the study
C) A sponsor representative who is knowledgeable about the study's unblinded information
D) A member from the IRB/IEC
5. Who should vote during the IRB/IEC review and discussion process?
A) All members who were involved in the review and discussion
B) All members who were involved in the review and discussion and non-member experts
C) All IRB/IEC members and non-member experts
D) All IRB/IEC members
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: C | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: A |




