Prerequisites
Introduction to Clinical Data Studio
Overview
In this course, you will learn about:
- What is Protocol Deviation in Clinical Research
- Roles and Permissions
- Clinical Data Studio Protocol Deviation Workflow
- Tasks that Project Managers or Central Monitors can perform in the Plan documents, and
- How Data Managers, Clinical Research Associates (CRAs)/, or Medical Monitors can identify and mitigate protocol deviations
For the roles - Project Managers/ Central Monitors, you will learn about:
What is the Protocol Deviation Assessment Plan (PDAP), and
Define Protocol Deviation Assessment Plan (PDAP) in Plan Documents
For the roles - Data Managers/ Clinical Research Associates (CRAs)/ Medical Monitors, you will learn about:
How to Propose Potential deviations from EDC queries
How to create Protocol Deviations Listings
How to manually create a Protocol Deviation Record, and
How to Review, Confirm, and Approve Protocol Deviations in Protocol Integrity Report (PIR)
Recording of Global Education training sessions is strictly prohibited. Any attempts to record training will result in an immediate stoppage of training until recording is terminated.
Course Type
eLearning
Duration
30 min
Product
Data Managers, Functional Managers, Monitors, Programmers, Project Managers (Clinical), Protocol Developers/Medical Writers, Reviewer Personnel, Statisticians, Study Managers, System Administrators/Clinical
Course Supplements
Course Outline - RBQM: Identify and Mitigate Protocol Deviations - ENG