What’s so Special About FDA Trials – Post Quiz – ECHO IDeA States Pediatric Clinical Trials Network

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Question 1 of 3

1. Question
“The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal government. Title 31 of the CFR is reserved for rules of the Food and Drug Administration.”
- True
- False
Question 2 of 3

2. Question
Which Form is to be completed by a site investigator at each medical school, hospital, or other research facility where the IND clinical investigation will be conducted?
- Form 2172
- Form 1572
- Form 1250
- Form 1752
Question 3 of 3

3. Question
Per 21 CFR 312, Investigators are responsible for all except the following for Investigational New Drugs (INDs):
- Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator’s care; and for the control of drugs under the investigator.
- Control of the investigational administering the drug only subjects under the investigator’s personal supervision or under the supervision of a sub-investigator responsible to the investigator.
- Ensuring that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND.
- Recordkeeping and record retention such as maintaining adequate records of drugs; adequate and accurate case histories; and record retention 2 years after the investigation is discontinued and FDA is notified.

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