Training Program Title

IND/IDE Sponsor Investigator Training

CTSA Hub Administered

yes

Contact Information

UM-MICHR@umich.edu

Training Program Description

This is a training module for investigators who will hold an IND or an IDE and are thus considered a sponsor-investigator under the FDA regulations. It provides information regarding the sponsor-investigator requirements of an IND or IDE and resources in order to be in compliance with FDA regulations. This module will allow you to indicate if you are using a drug or a device so that the information presented is relevant to your study. The training module is also available to anyone else who is interested in learning about the roles and responsibilities of IND or IDE sponsor investigators.

Competency Keywords

IDE (Investigational Device Exemption), IND (Investigational New Drug or Device), Sponsor

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Medicines Development and Regulation

Learning Objectives

1. Understand the purpose of an IND or IDE and the applicable Code of Federal Regulations

2. Understand the Responsibilities of IND or IDE Sponsors and Investigators under the FDA regulations

3. Understand the IND or IDE Maintenance Requirements for a sponsor-investigator

Delivery Method

Online

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level

Fundamental

Onboarding

yes

Frequency

On demand

Associated Assessment

yes

Assessment Methods

Learning outcomes

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