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Clinical Trials Resource Center

IND / IDE SUBMISSIONS

The IND and IDE criteria for determining if a drug or device study qualifies for an exemption can be found here:

CPHS Policy IV.1
CPHS Policy IV.2

Sponsor-Investigators at UTHealth must be aware of their specific obligations 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 INDs/ IDEs.

IND holder obligations:

For a complete list of investigator obligations, see CPHS Policy VII.1

FDA Forms, and instructions: (Please note that expired forms are okay to use if new ones have not yet been issued by the Agency.

Investigators

Investigators

Guidance:

Related Links:

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

last modified October, 2013
Copyright © 2012
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