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:

• 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 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.

• 1571 - Investigational New Drug Application
• 1572 - Statement of the Investigator
• 3454 - Certification: Financial Interest and Arrangements of Clinical

Investigators

• 3455 - Disclosure: Financial Interest and Arrangements of Clinical

Investigators

• 3500A - Medwatch Mandatory Reporting for Drugs and Devices
• 3674 - Certification of Compliance with Requirements of
            ClinicalTrials.gov Data Bank

Guidance:

• Content and format of IND applications
• Investigational New Drug applications
• Emergency IND (single patient, anti-viral)
• Treatment IND (serious or life-threatening)
• Individual Patient IND
• Exploratory INDs (aka Phase 0)
• Biological IND submissions
• IDE policy
• IDE required elements
• IDE cover letter
• Sponsor’s Responsibilities for Significant Risk Device Investigations
• Device Classification

Related Links:

• Computerized Systems

Regulations:

• 21 CFR 312 summary of responsibilities