About Sponsor Investigator (SI) Support

The Human Research Protection Program's Sponsor Investigator Support provides assistance to investigator-sponsors in preparing, submitting, and maintaining applications to the Food and Drug Administration (FDA) in the conduct of FDA-regulated research. Our goal is to provide the UTSW community with oversight, tools, training and support needed to navigate the complex regulatory pathways that accompany FDA regulated clinical investigation.

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 by all UTSW faculty, students, or staff. This shadow file will include all applications, reports, and communication between the study team and the FDA. 

Service Types

Consultation Schedule a one-on-one consultation today!

The SI Support staff assist with:

• Determination of regulatory pathway
• Drug/biologic/device development
• Pre-IND meeting requests to FDA

Material Review

The SI Support staff review IND/IDE/EAP applications including:

• FDA required forms
• Original IND/IDE/EAP applications
• Cover Letters
• Protocol 
• Informed Consent
• Manufacturing information
• Animal Pharmacology/toxicology data

Submission

The SI Support staff provide assistance with submission to the FDA. The staff:

• can submit materials on behalf of the investigator to the FDA, if requested. This will ensure timely processing and responses to any concerns raised by the FDA.
• can assist with the preferred electronic submissions to the CDER NextGen Portal for INDs.

Maintenance

The SI Support staff assist with preparation of (and responses to FDA comments) for:

• Annual reports
• Amendments
• Safety and Adverse Event reports
• Request for Withdrawal or Inactivation
• All FDA forms and correspondence

Education Schedule a training today!

Upcoming Workshops

• “FDA Regulated Mini Series: Drugs & Device” presented at Research Matter (March, 2023).

Past Events

• “Introduction to Sponsor Investigator Support” presented at Research Matters (January 18, 2022)