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Workshop 2: ELECTRONIC ARCHIVES ARE NOT YOUR SYSTEM BACKUP MEDIA

Tutorial name:
Workshop 2: ELECTRONIC ARCHIVES ARE NOT YOUR SYSTEM BACKUP MEDIA

Day & Time:
October 7, 2:00PM - 5:30PM

Room Number:
Hotel Clarion 2

Description:
Retention for study records today includes electronic CRFs and electronic source data at the sites as well as in the sponsor's Trial Master File. Proper indexing and handling of media for long term retention is new to many investigator study teams. This workshop builds awareness for e archive practices needed to preserve electronic raw data from studies. The need to recreate study results from long retained data is a regulatory requirement for GCP trials. System backup media do not constitute an electronic archive. There is a science to good archive practices in this workshop we explore them.

Learning Objective(s):
• Differentiate the roles for system backups versus electronic archives • Describe the archivist principles for data preservation • Know the non-IT practices for building and managing an electronic archive

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