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Submit IND/IDE reports

Information:

  • The FDA requires that you submit a final report for your IND/IDE upon closure of your clinical research project. The final report for an IND is included in the Annual Report for the project.
  • At minimum, this report should include:
      • Brief summary of study progress in relation to investigational plan
      • Number and demographics of subjects enrolled, number of subjects who have been lost to follow-up, and number of subjects who have withdrawn from the study
      • Amount/number of drug/devices received and used, and the final disposition of unused devices/drug
      • Brief summary of results and conclusions
      • Summary of anticipated and unanticipated adverse events/device effects
      • Description of any deviations from the investigational plan
      • Reprints of any articles published by the investigator in relation to the study

Resources:

Partners QI Program FDA Corner
US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) Reports
US Food and Drug Administration (FDA) Investigational New Drug Application (IND) Federal Regulations for Clinical Investigators: Investigator Reports

Courses:
Good Clinical Practice in Research at an Academic Research Institution
IND/IDEs: Beyond the Basics of Investigational Product Applications
Medical Device Development (Harvard Catalyst)

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