Training Program Title

IND and IDE Sponsor and Investigator Training

Contributor

Duke University

CTSA Hub Administered

yes

Contact Information

Duke University

Office of Regulatory Affairs and Quality

ORAQ@duke.edu

Training Program Description

This training provides information regarding the sponsor and investigator requirements for an IND or IDE as well as resources to ensure compliance with FDA regulations.

There are two separate training modules that each focus on the requirements for the specific regulatory application that the sponsor or sponsor-investigator holds. Sponsors who hold an IND (for drugs and biologics) can complete the training module entitled “IND Sponsor and Investigator Responsibilities." Sponsors who hold an IDE (for medical devices) can complete the training module entitled “IDE Sponsor and Investigator Responsibilities.”

Duke University's Office of Regulatory Affairs and Quality created versions of the training modules that are available to academic institutions outside of Duke at no cost. They are available in a format that is compatible with most Learning Management Systems (LMS) to give you the ability to track registration and completion of training. They are also available in an HTML format for web viewing and as PDFs. Please visit our website to learn more and to request the modules.

Competency Keywords

Biologic, Device, Drug, Investigational device, FDA (Food and Drug Administration), IDE (Investigational Device Exemption), IND (Investigational New Drug or Device), Sponsor, Adverse event, PI oversight, Regulatory guidelines, Reporting requirements, Safety reporting

Digital Commons Disciplines

Medical Education

Public

no

Cost to Access

no

Competency Domains

Medicines Development and Regulation

Learning Objectives

The learning objective is to understand IND and IDE regulatory responsibilities for sponsors and investigators.

Delivery Method

Online

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level

Fundamental

Onboarding

yes

Frequency

On demand

Time Needed

1 hour

Associated Assessment

yes

Assessment Methods

Learning outcomes

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