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| Section | Objectives |
|---|---|
| Topic 1: Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
| Topic 2: Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
| Topic 3: Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Topic 4: Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Topic 5: Study Operations | - Study conduct and oversight - Study planning and initiation |
1. The composition of an IDMC/DSMB should include which one of the following?
A) A clinical scientist who is knowledgeable in the appropriate discipline
B) A member from the IRB/IEC
C) A lead PI for the study
D) A sponsor representative who is knowledgeable about the study's unblinded information
2. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
A) Placebo-controlled
B) Privacy controls
C) Blinding
D) Randomization
3. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?
A) Notify the sponsor.
B) Notify the PI.
C) Call the participant to return for an unscheduled visit.
D) Report a protocol deviation to the IRB/IEC.
4. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?
A) 80%
B) 71%
C) 77%
D) 66%
5. The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:
A) Quality Assurance
B) Validation
C) Programming
D) Quality Control
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: D | Question # 3 Answer: B | Question # 4 Answer: C | Question # 5 Answer: B |
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