Training Program Title

Investigational Device Exemption (IDE) Sponsor-Investigator Studies

CTSA Hub Administered

no

Training Program Description

7/13/17 (live session recorded) Presenter: Angela Emerson, MPH; Carson Reider, PhD Objectives: 21 CFR 812 review and definitions; Does the device require and IDE? IDE Application process; Device research process - physician sponsored IDE

Competency Keywords

IDE (Investigational Device Exemption), Device, Clinical trial, Sponsor

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Scientific Concepts and Research Design; Ethical and Participant Safety Considerations; Medicines Development and Regulation

Learning Objectives

  1. 21 CFR 812 review and definitions
  2. Does the device require and IND?
  3. IDE (Investigational Device Exemption) application process
  4. Device research process
  5. Physician sponsored IDE (Investigational Device Exemption)

Delivery Method

Online

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level

Skilled

Onboarding

no

Frequency

Monthly

Time Needed

61:01 minutes

Associated Assessment

no

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