Skip Navigation and Go To Content

Clinical Trials Resource Center

IND / IDE SUBMISSIONS

Sponsor-Investigators at UTHealth must be aware of their specific responsibilities as both the investigator and sponsor of their study and must also ensure compliance with all applicable regulations in maintaining and conducting their research under an IND or IDE.

IND holder responsibilities and IDE holder responsibilities include:

For a list of investigator responsibilitiess per UTHealth policy, see CPHS Policy VII.1

FDA Forms: (Expired forms are acceptable if new ones have not yet been issued by FDA)

Guidance:

Regulations:

ADDITIONAL RESOURCES

CLINICAL RESEARCH UNITS (CRU) | BERD | REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS | ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH 

Center for Clinical and Translational Sciences

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795

Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu