Getting Started Set Up Conduct Close Next Steps

The United States Food and Drug Administration (FDA) requires that clinical investigators submit a final report for an investigational new drug (IND) or investigational device exemption (IDE) upon closure of a clinical research project.

The final report for an IND is included in the annual report for the project.

At minimum, this report should include:

  • A brief summary of study progress in relation to the 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demographics of subjects enrolled, number of subjects who have been lost to follow-up and number of subjects who have withdrawn from the study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 drugs/devices received and used, and the final disposition of unused devices/drugs
  • 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

Learn More

The Division of Clinical Research (DCR) at Massachusetts General Hospital helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.

Resources

Courses

Additional Support

Back to Top