Centralized Study Spec I
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Summary of Responsibilities: Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks Support system compliance and system data entry, as applicable File required task-related documentation in the Electronic Trial Master File (eTMF) Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines. Liaising and follow-up with...
- GCP
- Excel