【PURPOSE】

The purpose of this Standard Operating Procedure(SOP) is to describe the activities related to the
clinical requirements for obtaining, labeling, packaging, and shipping investigational product
（including comparators)and auxiliary medicinal product; and the management of the
investigational product and auxiliary medicinal product at the site. For purposes of this SOP, the term investigational product is used to refer to investigational product(including comparators),
locally sourced or site sourced commercial product, and auxiliary medicinal product unless
otherwise specified:
Activities include:

• Contributing to,reviewing and approving a clinical supply agreement for the study.
• Contributing to, reviewing and approving the investigational product manual.
• Reviewing and approving the clinical label text.
• Setting up study drug distribution and supply systems.
• Maintaining investigational product at the site.

【SCOPE】

This SOP applies to all interventional studies except defined before study execution.