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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Quality Management | - Audit and inspection readiness
|
| Topic 2: Data Management and Documentation | - Clinical trial documentation
|
| Topic 3: Professional Responsibilities | - Communication and collaboration
|
| Topic 4: Ethical and Participant Safety Considerations | - Regulatory compliance
|
| Topic 5: Clinical Trial Operations | - Study conduct
|
ACRP Certified Professional Sample Questions:
1. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?
A) A witness
B) A family member
C) A member of the research team
D) A legally acceptable representative
2. The composition of an IDMC/DSMB should include which one of the following?
A) A sponsor representative who is knowledgeable about the study's unblinded information
B) A lead PI for the study
C) A member from the IRB/IEC
D) A clinical scientist who is knowledgeable in the appropriate discipline
3. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?
A) Quarantine IP without registering in IWRS and request replacement from sponsor.
B) Dispose of IP and request replacement from sponsor.
C) Register IP in IWRS, quarantine and notify sponsor of the excursion.
D) Register IP in IWRS and continue with subject allocation.
4. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?
A) Locate a translator and have them work with the person.
B) Have the Principal Investigator consent the person.
C) There are no circumstances under which this person can be enrolled.
D) Get an impartial witness involved in consenting this person.
5. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:
A) Source document.
B) CRF.
C) Worksheet.
D) PRO.
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: D | Question # 5 Answer: B |
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