Exam Name: ACRP Certified Professional Exam
Certification Provider: ACRP
Corresponding Certification: ACRP Certified Professional
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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Topic 2: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 3: Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
| Topic 4: Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Topic 5: Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
ACRP Certified Professional Sample Questions:
Question 1
Who is responsible for the ongoing safety evaluation of the IP?
A. Sponsor
B. PI
C. Regulatory agency
D. IRB/IEC
Question 2
The composition of an IDMC/DSMB should include which one of the following?
A. A lead PI for the study
B. A sponsor representative who is knowledgeable about the study's unblinded information
C. A clinical scientist who is knowledgeable in the appropriate discipline
D. A member from the IRB/IEC
Question 3
Source data/documentation should be:
A. Attributable, legible, correct, original, accurate, and clear.
B. Attributable, legible, correct, original, accurate, and complete.
C. Attributable, legible, contemporaneous, original, accurate, and clear.
D. Attributable, legible, contemporaneous, original, accurate, and complete.
Question 4
A study protocol must contain which of the following elements?
A. Chemical structure of the IP
B. Data management plan
C. Description of statistical methods
D. Participant reimbursement details
Question 5
An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?
A. Sponsor
B. PI
C. DSMB/IDMC
D. IRB/IEC
Solutions:
| Question 1 Answer: A | Question 2 Answer: C | Question 3 Answer: D | Question 4 Answer: C | Question 5 Answer: B |
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