Study Designers
New Features
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APPLICATION
EDC
- Getting Started
- Study Design Process Overview
- Navigation in Studio
- Creating a Study
- Creating a New Study
- Copying Designs from Other Studies
- Designing Library Collections
- Study-level Configuration
- Managing Study Settings
- Creating Signature Definitions
- Building the Study Schedule
- Creating Event Groups & Events
- Building the Schedule
- Configuring Cycles (Repeating Event Groups)
- Tips & Best Practices for the Study Schedule
- Designing Forms
- Creating Forms, Item Groups & Items
- Designing Forms
- Configuring Repeating Forms & Item Groups
- Defining Default Units & Conversions
- Enabling Forms for Coding
- Tips & Best Practices for Forms
- Subject Groups
- Creating & Assigning Subject Groups
- Labs Configuration
- How to Get Started with Labs
- Using the Labs Module
- Viewing and Updating Analytes
- Viewing and Editing Lab Locations and Normal Ranges
- Configuring Labs in Studio
- Study Settings
- Lab Reports
- Making Changes to Labs Post Go Live
- Tips & Best Practices for Labs
- Randomization Configuration
- Using the Randomization Module
- Configuring Randomization in Studio
- Clinical Review Assessments
- Configuring Assessments
- Review Plans for SDV & DMR
- Creating a Review Plan
- Creating Review State Definitions for Event Dates
- Protocol Deviations
- Configuring Protocol Deviations
- Using Rules to Support Study Design
- Creating Rules (V2)
- Creating Rules (V1)
- Casebook Variables
- Comparison Rules
- Sending Email Notifications with Rules
- Rule Design Properties
- Tips & Best Practices for Rules
- Vault-level Configuration
- Configuring Custom Change Reasons
- Versioning & Deployment
- Casebook Versioning Overview
- Working with Casebook Versions in Studio
- Importing & Exporting a Casebook Definition (ODM)
- Comparing Casebook Versions
- Creating Study Specifications
- Deleting Non-production Test Data
- Reference
- CDMS Design Properties Reference
- Naming Conventions
- Study Update Restrictions
- Publishing Validation Errors & Warnings
- Upgrading a Study from Manual to Automatic Deployments