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| Section | Objectives |
|---|---|
| Topic 1: Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
| Topic 2: Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Topic 3: Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
| Topic 4: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 5: Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
1. 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) Register IP in IWRS, quarantine and notify sponsor of the excursion.
B) Quarantine IP without registering in IWRS and request replacement from sponsor.
C) Register IP in IWRS and continue with subject allocation.
D) Dispose of IP and request replacement from sponsor.
2. 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
3. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?
A) Standard Operating Procedure
B) Clinical Monitoring Plan
C) Data & Safety Monitoring Plan
D) Investigator's Brochure
4. Who is responsible for the ongoing safety evaluation of the IP?
A) IRB/IEC
B) PI
C) Regulatory agency
D) Sponsor
5. A root cause analysis should be:
A) Validated before use in a CAPA.
B) Written by the investigator.
C) Specific to a clinical trial.
D) Focused on issues of non-compliance.
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: A | Question # 3 Answer: A | Question # 4 Answer: D | Question # 5 Answer: D |
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