The Regulatory Knowledge and Support (RKS) Program’s Investigational New Drug and Investigational Device Consultation Service supports investigators in their interactions with the U.S. Food and Drug Administration (FDA).
RKS offers assistance 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. We also assist investigators in preparing IND and IDE applications. The RKS Program partners with the Quality Improvement Office to provide tools and education to investigators who hold an IND or IDE.
Toolkit:
Application Templates:
Indiana CTSI Initial IND Application
Indiana CTSI Initial IDE Application
FDA Forms:
FDA Form 1571: Investigational New Drug (IND) Application
Form | Instructions
FDA Form 1572: Statement of Investigator
Form | Instructions | FAQS
FDA Form 3674: Certification of Compliance
Form | Guidance
Annual Reports:
Indiana CTSI Annual IND Report Template
Indiana CTSI Annual IDE Report Template
Expanded Access (Compassionate Use):
Form | Information for Physicians
Guidance on Expanded Access Applications for IND
FAQ on Expanded Access to Investigational Drugs for Treatment Use
Guidance on Charging for Investigational Drugs under IND
Expanded Access for Medical Devices
FDA General Guidance
IND Applications Prepared and Submitted by Sponsor-Investigators