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Site, Sponsor, & IRB: Who Should Know What, When

Apr 27, 2009 11:30am ‐ Apr 27, 2009 12:30pm

Credits: None available.

Non Member: $25.00


Industry Newcomers & seasoned practitioners find the regulations governing human subject protections, particularly documents requiring approval prior to use, vague & confusing. This confusion can lead to: 1) information given to subjects without review & approval 2) sites non-compliant with regulations 3) sponsors providing incorrect information on approvals 4) IRBs unaware of site issues regarding subject information


  • Dr. Felix Gyi, PharmD, MBA, CIP, RAC, CEO, Chesapeake Research Review, Inc
  • Yvonne McCracken, MPH, Vice President Clinical Operations & Compliance, RxTrials, Inc


Credits: None available.

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