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STEPS TO STUDY ACTIVATION

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Consultation with CTSI for IND/IDE Submission

The Indiana CTSI Regulatory Knowledge and Support program (RKS) offers consultations on drugs, biologics, and devices in research and supports investigators interacting with the U.S. Food and Drug Administration (FDA). RKS helps investigators with:

  • Identifying the appropriate regulatory pathway for drugs and devices, including determining whether an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application is required
  • Requesting IND and IDE exemptions and submitting Pre-INDs and Q-Submissions (Pre-IDEs) 
  • Consulting on IND and IDE applications
  • Advising on Expanded Access requests
  • Providing education and tools to investigators who hold an IND or IDE (sponsor-investigators). 

For more information and templates, visit the RKS website. 

For cellular therapy trials, visit Cellular Therapy & Immune Effector Cell Trials.

Budget Planning

There is no cost for RKS consultation or assistance. However, holding an IND or IDE can impact the cost of oversight for the trial. If an IND or IDE is necessary, the FDA requires the sponsor-investigator to ensure proper monitoring throughout the trial. Monitors must be qualified by training and experience. RKS offers a clinical research monitoring service to sponsor-investigators to meet these responsibilities. For more information, visit RKS website or contact ctsireg@iu.edu to request an estimate.

Investigational drugs must be managed by Investigational Drug Services (IDS). For information about the IDS process and to request an estimate for IDS services, visit the Investigational Drug Services page.

For questions contact RKS at ctsireg@iu.edu. 

IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information

For Cancer Center Trials (studies involving cancer patients):

For IND or IDE studies involving cancer center patients, please reach out to the Cancer Center’s Protocol Development Team for more information on submitting an IND or IDE for oncology research.

Resources

FDA

NIH Regulatory Toolbox

 

If necessary, consultation with the CTSI for IND or IDE Submissions is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.