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Scientific Investigations
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Knowledge Check

Which of the following is not a main objective of bioresearch monitoring?
- Ensure that FDA-regulated research is being conducted in compliance with regulations
- Verify the eligibility of human subjects enrolled in clinical trials
- Ensure the safety and welfare of human subjects enrolled in clinical trials
- Verify the quality and integrity of submitted data
About which of the following are participants in clinical trials required to be informed?
- Potential risks or discomforts
- Available compensation or medical treatments
- The voluntary nature of their participation
- All of the above
Which of the following is a sponsor of a clinical trial obliged to do?
- Submit an Investigational New Drug Application to FDA before conducting a clinical investigation
- Require that compensation of the human participants complies with IRB regulations
- Disclose the origin of all drugs to be used in the trial
- All of the above
Which of the following is not a responsibility of a clinical investigator?
- Provide transportation for subjects located in rural communities
- Obtain informed consent of subjects in the drug trials
- Protect the rights, safety and welfare of subjects
- Ensure research is conducted according to protocol
The two types of FDA inspections are routine ones in support of NDAs and directed ones responding to reports of serious problems. True or false?
- True
- False

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