The RKS 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:

  • FDA Forms:

FDA Form 1571: Investigational New Drug (IND) Application
Form | Instructions

FDA Form 1572: Statement of Investigator
Form | Instructions

Guidance for Statement of Investigator

FAQS for Form 1572

FDA Form 3674: Certification of Compliance
Form | Instructions

Guidance for Certification Compliance

  • Applications:

Indiana CTSI Initial IND Application (PDF)

Indiana CTSI Initial IDE Application (PDF)

  • Sponsor-Investigator Responsibilities:

Sponsor-Investigator Responsibilities for INDs (PDF)

Sponsor-Investigator Responsibilities for IDEs (PDF)

Annual Reports:

Guidance for Annual Reports

Templates:

Indiana CTSI Annual IND Report Template (PDF)

Indiana CTSI Annual IDE Report Template (PDF)

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

  • Drugs

Center for Drug Evaluation and Research Guidance Documents

IND Applications Prepared and Submitted by Sponsor-Investigators

  • Biologics 

Center for Biologics Evaluation and Research (CBER)

  • Devices

 Center for Devices and Radiological Health

Device Advice

The Pre-Submission Program and Meetings with Food and Drug Administration Staff (formerly Pre-IDE process)

Request for Feedback on Medical Device Submissions