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| Section | Objectives |
|---|---|
| Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
| Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
| Study Operations | - Study planning and initiation - Study conduct and oversight |
| Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
1. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?
A) Any trial-related duties can be documented as transferred by verbal agreement.
B) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
C) All duties transferred to a CRO should be specified in writing.
D) The IRB/IEC must approve the transfer of duties to a CRO.
2. 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) CRF.
B) Worksheet.
C) PRO.
D) Source document.
3. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?
A) Sponsor
B) Investigator
C) CRA
D) CRC
4. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:
A) 8 calendar days
B) 7 calendar days
C) 30 calendar days
D) 15 calendar days
5. What would a sponsor use to implement and maintain quality in a study?
A) Clinical trial agreement
B) Standard operating procedures
C) Protocol signature pages
D) Statistical analysis plan
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: A | Question # 3 Answer: B | Question # 4 Answer: D | Question # 5 Answer: B |
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