DIA 2019 Global Annual Meeting

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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.