Originally Published MDDI October 2002

INTERNATIONAL AFFAIRS

• Return to Article: Device Regulation in Asia: An Update

  Explain the purpose of the study clearly and simply.

• Distinguish investigational treatment from standard care.
• Avoid overstating the potential benefit of the investigational treatment.
• Focus on physical and nonphysical risks associated with the investigational treatment as a whole.
• Estimate broadly the likelihood of the risks associated with the investigational treatment.
• Provide supplementary documents that are easy to read and culturally sensitive, and continue to provide these materials throughout the lifetime of the study.

Copyright ©2002 Medical Device & Diagnostic Industry