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Sponsor Investigator (SI) Support

About Sponsor Investigator (SI) Support

The Human Research Protection Program's Sponsor Investigator Support was established to provide assistance to investigators with submission and maintenance of investigator-sponsored Investigational New Drug (IND) and Investigational Device Exemptions (IDE) with the U.S. Food and Drug Administration (FDA). It is the responsibility of sponsor-investigators to maintain compliance with FDA regulations. The SI Support Team will provide support campus-wide to principal investigators (PIs) and sponsor-investigators (SIs) in regulatory matters that involve the Federal and Drug Administration (FDA). PIs/SIs planning to conduct new clinical research studies or those performing studies under an FDA approved IND (investigational new drug) or IDE (investigational device) by the FDA are required to meet regulatory compliance both at the institutional level (UTSW HRPP/IRB) and at the federal level (FDA) before using the drugs and devices in their studies.  

UT Southwestern requires oversight of sponsor-investigators. To provide necessary support and oversight, the HRPP requires that all IND/IDE submissions to the FDA also be reported to the HRPP Regulatory Support Office's SI Support Team. The SI Support Team will maintain a shadow file of all IND and IDE investigations held UTSW faculty, students, or staff. This shadow file will include all applications, reports, and communication between the study team and the FDA. PIs and SIs are encouraged to contact the SI Support Team or review this website to obtain specific guidance materials or templates prior to submitting IND/IDE applications to the FDA.

Help with Submissions and Reporting

The SI Support Team will provide support with initial applications to the FDA as well as reporting. The support provided includes any/all of the following as needed:

  • Consultation
    • The SI Support staff will meet with study teams to discuss the process, responsibilities, and timeline.
    • When comments/questions are received from the FDA, the SIS staff will review and provide assistance with drafting an appropriate and professional response. 
  • Material Review
    • The SI Support staff will review applications, reports, etc. to ensure they are complete and that the appropriate formatting was used.
    • Before submission, the SIS staff will ensure the files are the appropriate type to ensure FDA acceptance of the materials.
  • Submission
    • The SI Support staff will submit the materials on behalf of the investigator. This will ensure timely processing and timely responses to any concerns raised by the FDA. 
    • The SI Support staff have an account with CDER NextGen Portal and can assist with the preferred electronic submissions. 

What is an IND or IDE?

Investigational New Drug (IND)

Small molecular or biological drug used for clinical investigation outside of the use the of a marketed drug used on-label in clinical practice. The term also includes a biological product that is used in-vitro for diagnostic purposes. An IND Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

Investigational Device Exemptions (IDE)

Device that is used for a clinical investigation to collect new safety and effectiveness data. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.  

Do I Need an IND or IDE?

Does your research involve:

  • A drug/biological product or investigational device?
  • Is the drug/product/device used in a clinical research investigation with human subjects?
  • Did you/your collaborators (non-industry) design the study? 

If yes to all, you probably need an investigator-sponsored IND or IDE! 

 

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