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 | Instructions | Guidance

Annual Reports:

Guidance for 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 

Center for Drug Evaluation and Research Guidance Documents

Device Advice