Standard Operating Procedures (SOPs)
SOP for Handling Study Drug

Policy for Drug Diversion

Purpose:
To ensure that all Investigational Medications/Products used in the proper manner only by those research subject volunteers enrolled in the study per GCP Guidelines.

Scope:
To eliminate chance someone other than the research subject volunteer will get hurt will get exposed and potentially hurt by the Study Drug.

Responsibility:
This SOP applies to all staff employed by Drug Study Institute.

Procedures:

Any DSI employee who has knowledge of drug diversion by a fellow employee is required to report it to the Project Manger immediately.
DSI employees found in possession of Study Drug outside the scope of practice including: sale; personal use; theft, will be terminated immediately and reported to the local authorities.