Description
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
Speaker(s):
- Dr. Felix
Gyi,
PharmD, MBA, CIP, RAC,
CEO,
Chesapeake Research Review, Inc
- Yvonne
McCracken,
MPH,
Vice President Clinical Operations & Compliance,
RxTrials, Inc
