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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: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 5: Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
1. Who ensures information regarding payments to subjects is documented in a written consent form?
A) Sponsor
B) PI
C) Coordinator
D) IRB/IEC
2. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?
A) There are no circumstances under which this person can be enrolled.
B) Locate a translator and have them work with the person.
C) Have the Principal Investigator consent the person.
D) Get an impartial witness involved in consenting this person.
3. A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?
A) The site should retain the essential documents longer to meet the regulatory requirements.
B) The site may proceed with the destruction of the essential documents.
C) The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
D) The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
4. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
A) Co-monitoring of CRO site visits
B) Risk-based audits of CRO activities as delegated
C) Central monitoring of data fields by sponsor
D) Pre-qualification assessment of CRO
5. Centralized monitoring can:
A) Confirm why sites are deviating from the protocol.
B) Identify IP accountability and storage issues.
C) Enable appropriate stratification of subject enrollment.
D) Indicate the need to send monitors to perform onsite visits.
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: D | Question # 3 Answer: D | Question # 4 Answer: B | Question # 5 Answer: D |
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