KLH-11

Institutional review board/independent ethics committee (IRB/IEC) of ICH Guideline for Good Clinical Practice (E6, May 1, 1996).  

Translation of Chapter 3. of ICH Guideline for Good Clinical Practice (E6, May 1, 1996), which defines principles of work of ethics committees. Text of the guideline is not modified or changed.

This provision is valid as of August 1, 1998.