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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
| Topic 2: Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Topic 3: Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Topic 4: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 5: Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
ACRP Certified Professional Sample Questions:
1. 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) CRO
B) Sponsor
C) Data Manager
D) CRA
2. In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?
A) PI
B) CRC
C) CRA
D) IRB/IEC
3. An impartial witness should be present during the entire informed consent discussion when:
A) A legally acceptable representative is unable to read.
B) An interpreter is translating the consent form for a subject.
C) A parent/guardian is consenting for a minor subject.
D) A subject has been determined to be vulnerable.
4. While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:
A) PI
B) CRO
C) CRC
D) Sponsor
5. A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:
A) The site receives approval from the medical monitor to begin enrolling.
B) A signed clinical trial agreement between the site and sponsor is in place.
C) The CRA has performed source document review and verification at the site.
D) The DSMB meets and the first DSMB meeting report has been issued.
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: A | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: B |
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