Identify Funding Opportunities Proposal Development Award Management Compliance Review and Oversight Education and Training Technology Transfer
Office of Research and Technology Management
Identify Funding Proposals Proposal Development Award Management Compliance Review and Oversight Education and Training Technology Transfer

IND Quiz for CREC

Successful completion of this quiz is valid for four (4) continuing credits.

Fill in the appropriate information below (Case Network ID is NOT required) and click on your choice to answer each of the quiz questions.

 

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Please answer the following questions:


1. The responsibilities of a Sponsor-Investigator fall upon which of the following:
      a.   The agency providing the funding for the IND or IDE
      b.   The individual who both initiates and conducts an investigation, and under whose      immediate direction the investigational drug is administered or dispensed
      c.   The institution by which the person responsible for submitting the IND or IDE is employed
      d.   The organization providing the drug or the device

2. As a Sponsor Investigator for an Investigator Initiated IDE, which of the following are required elements to consider including in the management of the trial?
      a.   Monitoring
      b.   21 CFR Part 11 compliant database
      c.   Responsibility for direct reporting to the FDA for reportable unanticipated adverse device effects
      d.   All of the above

3. Which of the following should always be included in the initial IND application;
      a.   Informed consent
      b.   CRF
      c.   Monitoring plan
      d.   None of the above

4. Which of the following would indicate that an IDE is required?
      a.   Significant risk device used in supporting or sustaining human life substantially important in diagnosing, curing, mitigating, or treating diseases, or in preventing impairment of human health
      b.   A device intended solely for veterinary use
      c.   A device shipped solely for research on or with laboratory animals
      d.   All of the above

5. The FDA will not inspect Investigator Initiated INDs or IDEs.
      a.   True
      b.   False

6. For INDs, an FDA Form 1571 should be included in all correspondence to the FDA.
      a.   True
      b.   False

7. Which of the following must be reported to the FDA as amendments?
      a.   Conducting a new clinical study under an existing IND.
      b.   Changes to an existing clinical protocol if the change impacts safety, the scope of the investigation, or the quality of the study
      c.   Addition of a new investigator
      d.   All of the above

8. The Sponsor Investigator is expected to have SOPs for sponsor responsibilities.
      a.   True
      b.   False

9. Transfer of Obligations for an IND trial are documented in which of the following
      a.   Contract
      b.   Protocol
      c.   1571
      d.   A and C

10. An IND goes into effect (study may proceed) 30 days after the FDA receives the IND, unless the sponsor is notified otherwise by the FDA.
      a.   True
      b.   False