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ACRP ACRP-CP Exam Syllabus Topics:

SectionObjectives
Topic 1: Data and Quality Management- Quality assurance and quality control
- Clinical data management principles
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: Clinical Research Foundations- Good Clinical Practice (GCP) principles
- Ethical conduct in clinical trials

ACRP Certified Professional Sample Questions:

Question 1

Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

A. 3.0 mg/dL
B. 2.6 mg/dL
C. 1.8 mg/dL
D. 3.6 mg/dL


Question 2

The coding system for a double-blind clinical trial is accessible by the:

A. Sponsor
B. PI
C. IRB/IEC
D. Regulatory authority


Question 3

A root cause analysis should be:

A. Validated before use in a CAPA.
B. Specific to a clinical trial.
C. Focused on issues of non-compliance.
D. Written by the investigator.


Question 4

IP is dispensed to all subjects who:

A. Need IP for their medical condition.
B. Consented for the trial.
C. Are eligible to receive it in the trial.
D. Screened for the trial.


Question 5

Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A. Protocol, site coordinator CVs, and clinical trial agreement
B. IB, site coordinator CVs, and information about payments and compensation available to subjects
C. Protocol, informed consent, and clinical trial agreement
D. Protocol, IB, and information about payments and compensation available to subjects


Solutions:

Question 1
Answer: A
Question 2
Answer: A
Question 3
Answer: C
Question 4
Answer: C
Question 5
Answer: D

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