Resources related to Regulatory Support (MIAP)

• Abbreviated IDE Requirements

  This document describes the FDA regulations specific for conducting a clinical trial with a non-significant risk (NSR) device.

• Template for Investigator-Initiated Clinical Drug Trials (Non-Oncology)

  This is a protocol template for investigator-initiated clinical drug trials. It is not intended for use with medical device trials or hematology-oncology trials.

• IND/IDE Decision Worksheets

  This page includes decision worksheets for investigators who may need to submit an Investigational New Drug or Investigational Device Exemption Application.

• Resources for Compliance with FDA Regulations

  This pages includes decision worksheets and FDA guidance documents for investigators who may need to submit an Investigational New Drug or Investigational Device Exemption Application.

• Online Course: Investigational New Drug and Investigational Device Exemption Training Course

  This self-guided course is designed to introduce you to regulatory responsibilities of sponsors and investigators of drug and device studies.