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

ORSC Policy IV.1
ORSC Policy IV.2

Sponsor-Investigators at UTHSC-H 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.

Please contact us for more information regarding these obligations, which include, but are not limited to:

• 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, see ORSC Policy VII.1, and also refer to the Investigator’s Handbook.

The FDA website also offers many guidance documents and essential forms for IND/IDE applications:

FDA Forms, and instructions: (Please note that expired forms are okay to use if new ones have not yet been issued by the Agency. *FDA has OMB approval to use these forms until 8/31/2011)

• 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
  
• 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:

• Guide for Monitoring Clinical Investigations
  
• Computerized Systems

Regulations:

• 21 CFR 312 summary of responsibilities