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- 1. Multiple Choice
According to GCP the investigator "should be qualified by..."
Expertise, training and experience
Education, training and experience
Training and experience
Education and training
- 2. Multiple Choice
Sponsor responsibilities include
Design study
Finance study
Audit study
All of the above
- 3. Multiple Choice
The person responsible for the conduct of the clinical trial at a trial site.
Clinical research coordinator
Monitor
Investigator
Sponsor
- 4. Multiple Choice
How does GCP define who should handle and verify the data from a clinical trial?
Qualified data managers
Appropriately qualified individuals
Adequately trained individuals
GCP does state any requirement
- 5. Multiple Choice
According to the principles of GCP, what is the most important consideration when conducting a clinical trial?
Data accuracy
Protection of trial subjects
Process adherence
Statistical quality checks
- 6. Multiple Choice
Which of the following is NOT a requirement for Ethics Committees under GCP?
They should have SOPs
They should have one member who is independent of the trial site
Their members should not be paid
They should make decisions about approvals only at meetings
- 7. Multiple Choice
Which of the following words does not appear in GCP?
Placebo
Medicine
Medical
Treatment
- 8. Multiple Choice
According to ICH GCP what action should the sponsor take in the event of non-compliance by investigational site staff?
Prompt action to secure compliance
Immediate report to the regulatory authority
Legal action against the site
For cause audit
- 9. Multiple Choice
According to ICH GCP what does the C in CRO stand for?
Commercial
Clinical
Contact
Contract
- 10. Multiple Choice
According to GCP who is responsible for the content of the Patient Information Sheet?
The sponsor
The investigator
The Ethics Committee
The auditor
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