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| Section | Objectives |
|---|---|
| Topic 1: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 2: Data and Quality Management | - Clinical data management principles - Quality assurance and quality control |
| Topic 3: Participant Safety and Protection | - Informed consent process - Safety reporting and adverse events |
| Topic 4: Regulatory Compliance | - Audit and inspection readiness - Regulatory documentation and submissions |
| Topic 5: Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
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 legally acceptable representative
B) A family member
C) A member of the research team
D) A witness
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) Source document.
B) PRO.
C) CRF.
D) Worksheet.
3. When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:
A) PD affected participant safety.
B) PD affected participant recruitment.
C) Participant verbally agreed to the PD.
D) Sponsor approved the PD.
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. A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?
A) Alternate dose
B) Active control
C) Placebo
D) No treatment
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: C | Question # 3 Answer: A | Question # 4 Answer: C | Question # 5 Answer: C |
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