GCP Information

Reinforce your understanding of GCP with real-world examples
 

Coast IRB: A Cautionary Tale

A Government Sting Operation Brings Down Coast IRB

In a move that sent ripples of concern through the entire medical device and drug industry, Coast IRB in Colorado Springs, Colorado, permanently closed its doors after it was revealed in a congressional sting operation that Coast had approved a phony protocol. The shutdown affected approximately 300 clinical trials and involved more than 3000 researchers around the country.

This 8-page white paper provides:

  • A thorough description of this amazing story
  • A timeline of events
  • Pros and cons of central IRBs
  • A bonus of 17 hyperlinks to relevant publications and regulations
 

Learn more.

FDA Warning Letters


In the Clinical Research community, we dread the certified letter that arrives from the FDA simply titled, in all caps, WARNING LETTER. Whether it is directed to a major pharmaceutical company or an IRB, these letters are a not-so-gentle reminder of how we need to be vigilant in our jobs. Learn more.

Patty Kasper
 
 
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