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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Clinical Trial Operations | - Study conduct
|
| Topic 2: Quality Management | - Audit and inspection readiness
|
| Topic 3: Professional Responsibilities | - Leadership and professionalism
|
| Topic 4: Ethical and Participant Safety Considerations | - Human subject protection
|
| Topic 5: Data Management and Documentation | - Clinical trial documentation
|
ACRP Certified Professional Sample Questions:
During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?
- A. PI
- B. CRC
- C. Sponsor
- D. CRA
Correct Answer: A 🗳️
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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. Data Manager
- B. CRO
- C. Sponsor
- D. CRA
Correct Answer: C 🗳️
Explanation: Only visible for Actual4Exams members. You can sign-up / login (it's free).
When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:
- A. Participant verbally agreed to the PD.
- B. PD affected participant safety.
- C. Sponsor approved the PD.
- D. PD affected participant recruitment.
Correct Answer: B 🗳️
Explanation: Only visible for Actual4Exams members. You can sign-up / login (it's free).
Who is responsible for submitting a protocol amendment to the IRB/IEC?
- A. Investigator
- B. CRC
- C. Sponsor
- D. CRA
Correct Answer: A 🗳️
Explanation: Only visible for Actual4Exams members. You can sign-up / login (it's free).
A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:
- A. Investigator Brochure
- B. Clinical Study Protocol
- C. Clinical Study Report
- D. IDMC/DSMB Report
Correct Answer: C 🗳️
Explanation: Only visible for Actual4Exams members. You can sign-up / login (it's free).
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