![The Difference Between Practice and Research – What the FDA Expects You to Understand Harvey M. Arbit, PharmD, MBA, RAC, CCRP University of Minnesota Director, IND/IDE Assistance Program, Academic Health Center Adjunct Associate Professor, College of Pharmacy Phone 612-625-0930 Fax 612-625-3956 E-mail [email_address] www.ahc.umn.edu/research/ind-ide/](https://image.slidesharecdn.com/thedifferencebetweenpracticeandresearch111607-110505014014-phpapp01/85/the-difference-between-practice-and-research-111607-1-320.jpg)
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The difference between practice and research 111607
- 1. The Difference Between Practice and Research – What the FDA Expects You to Understand Harvey M. Arbit, PharmD, MBA, RAC, CCRP University of Minnesota Director, IND/IDE Assistance Program, Academic Health Center Adjunct Associate Professor, College of Pharmacy Phone 612-625-0930 Fax 612-625-3956 E-mail [email_address] www.ahc.umn.edu/research/ind-ide/
- 27. Good Clinical Practice (GCP)
- 32. Protocol Compliance It doesn’t matter who wrote the protocol – or whether the trial is funded by the DHHS or regulated by FDA – NO change can be implemented without prior IRB approval (except to mitigate immediate hazard). The plan submitted to (and approved by) the IRB cannot be changed without approval. Some changes must also be submitted to the FDA.
- 39. Data & Safety Monitoring Board (DSMB)
- 43. What FDA Looks For