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:

• Submitting annual FDA reports
• Controlling drugs and devices under investigation
• Ensuring that informed consent is obtained and that the study does not
  commence until FDA and IRB approvals have been obtained
• Maintaining records
• Reporting unanticipated adverse problems / device effects
• Providing adequate training and supervision of the study team
• Ensuring that the investigation is conducted according to the signed agreement, the investigational plan, and applicable FDA regulations
• Protecting the rights, safety, and welfare of subjects under the investigator's care

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)

• 1571 - Investigational New Drug (IND) Application Cover Sheet (for drug or biological product submissions)
• 3514 - CDRH Premarket Review Submission Cover Sheet (for device submissions)
• 1572 - Statement of the Investigator (for drug or biological product submissions)
• 3674 - Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank (for drug, biological product, or device submissions)
• 3454 - Certification: Financial Interest and Arrangements of Clinical Investigators (for drug, biological product, or device submissions)

• 3455 - Disclosure: Financial Interest and Arrangements of Clinical Investigators (for drug, biological product, or device submissions)

• 3500A - Medwatch Mandatory Reporting for Drugs and Devices

Guidance:

• Investigational New Drug (IND) Applications
• Investigational Device Exemption (IDE) Applications
• Expanded Access IND Applications (aka compassionate use)

Regulations:

• 21 CFR 312 - Investigational New Drug (IND) Applications
• 21 CFR 812 - Investigational Device Exemption (IDE) Applications
• 21 CFR 312 Subpart I - Expanded Access IND applications

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 

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