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Developing Standard Operating Procedures (SOPs)
September 26, 2018 @ 1:00 pm - 2:00 pm
Study teams are encouraged to create and maintain SOPs to help prevent non-compliance. This presentation will include an overview of the recommended SOPs that each program/department should have, the sections to include when writing SOPs, how to manage SOPs, and how to train study staff on SOPs. Furthermore, we will share some common challenges, lessons learned, and provide example SOP templates.
Amy Remm, FDA Research Quality and Compliance Monitor, ICTR
Jill Kubiak, Quality Assurance and Compliance Manager, UWCCC
Emily Putman-Buehler, firstname.lastname@example.org