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U.S. Department of Health and Human Services

Training and Continuing Education

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CDERLearn

Field Investigators: Adverse Drug Effects (ADE) Detectives (2000)

Man in hallway, walking out the door

 

Field Investigators are frontline protectors of public health and safety. To effectively carry out their jobs, they are required to know the relevant regulations that bind the firms they investigate.

The audio-visual self-learning modules developed in 2000 and available on this web site offer a comprehensive review of these FDA regulations.  The content of this course continues to be correct.  However, organizational changes have occurred and are reflected in the CDER organization chart.

With this knowledge, the Field Investigator will be able to facilitate the critical responsibility of collecting and documenting information associated with the adverse effects of drugs. No credit is offered for this course. (This video will be updated when new ADE regulations go into effect).
Streaming Video (September 2000)

RealPlayer:
-
28kbps (dial-up modem)
- 150kbps (network speed)

WindowsMedia:
- 28kbps (dial-up modem)
- 150kbps (network speed)

Watching the video may require installation of RealPlayer or WindowsMedia Player software.

Download the RealPlayer, Free

Download the Windows Media Player, Free

Video Slides  [PPT]

Video Transcript [PDF] (updated 12/2004)

Handbook to the Audio-visual Self-learning Modules [PDF] (updated 12/2004)

The FDA's Post-marketing Adverse Drug Experience Inspectional Program (Slides) [PPT]

Current CDER Organization Chart