1.         Purpose
The purpose of this Standard Operating Procedure (SOP) is to describe the requirements and process of Protocol Deviation (PD) management, including PD identification, documentation, reporting, reviewing and remediation. 

2.          scope
2.1         Process Scope
·        This SOP applies to clinical trials contracted with Sponsor.
·        If Sponsor’s specific procedure is required for PD management, it should be specified in contract or other document which SOP and/or process should be followed for certain activities.
2.2         Target Audience
This SOP applies to:
·           Staff within Clinical Operations (CO), Clinical Science &Medical Affairs (CSMA), Early Development and Clinical Pharmacology (EDCP), Project Management (PM), and other related dMed functions involved in PD management.
·           Parties with whom dMed contracted to perform described activities.