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GCP for Contributing Investigator Versus Conducting Investigator-Initiated Trials in Emerging Regions
Session Chair(s)
Terry Katz, MS
Senior Director, Biostatistics and DM Planning and Functional Excellence
Daiichi Sankyo, United States
Emerging regions are participating in clinical trials, but that only provides drug benefits to a small number of patients. Shifting to Investigator-initiated trials maximizes patient access, but requires more activities to be GCP compliant.
Learning Objective : Define GCP for Investigator-Initiated trials; Discuss strategies for GCP compliance in emerging regions.
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