Study Designers
New Features
- Schedule Grid Improvements for Dynamic Rules
- Local Labs: Fasting Status & Female Cycle Support for Normal Ranges
- Local Labs: Study Settings Error Messaging UI Update
- Local Labs: Update to Preview and Update Outdated Lab Normals Jobs
- Local Labs: Time Unknown for Lab Collection Datetime & Normal Range Effective Datetimes
- Repeating Item Group Data in Email Notifications
- Rule Editor Supports Country Code on @StudyCountry
- Schedule-driven Default Data
- Studio Copy Improvements
- EDC: Study Language & Locale for Blank PDFs
- Study Language for Studio Labels
- Study Locking & Billing Enhancements
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APPLICATION
Veeva EDC
- Getting Started
- Study Design Process Overview
- Navigation in Studio
- Training Assignments
- Creating a Study
- Creating a New Study
- Copying Designs
- Designing Library Collections
- Managing Library Classifications
- Study-level Configuration
- Managing Study Settings
- Creating Signature Definitions
- Study Translations
- Building the Study Schedule
- Creating Event Groups & Events
- Building the Schedule
- Configuring Cycles (Repeating Event Groups)
- Tips & Best Practices for the Study Schedule
- Visit Method
- Designing Forms
- Creating Forms, Item Groups & Items
- Importing Codelists
- Designing Forms
- Configuring Repeating Forms & Repeating Item Groups
- Configuring Form Linking & Item-to-Form Linking
- 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
- Managing Analytes, Units, & Codelists
- Managing Lab Locations, Normal Ranges, & Reports Mass Updates
- Configuring Labs in Studio
- Study General Settings for Labs
- Lab Reports
- Making Changes to Labs Post Go Live
- Tips & Best Practices for Labs
- Veeva EDC Imaging
- Configuring Imaging Exams
- Randomization Configuration
- Using the Randomization Module
- Configuring Randomization in Studio
- Medical Assessments
- Configuring Assessments
- Review Plans for SDV & DMR
- Creating a Review Plan
- Creating Review State Definitions for Event Dates
- Data Loader
- Data Import Configuration for Data Loader
- Protocol Deviations
- Configuring Protocol Deviations
- Safety Link
- Configuring Safety Link
- Configuring the Vault Safety EDC Connection
- Integration Configuration
- Send Procedure Notifications to CTMS (Studio)
- Using Rules to Support Study Design
- Creating Rules (V2)
- Creating Rules (V1)
- Cross-form Derivations
- Mapping Casebook Variables
- Comparison Rules (V2)
- Comparison Rules (V1)
- Sending Email Notifications with Rules
- Rule Design Properties
- Tips & Best Practices for Rules
- Vault-level Configuration
- Creating Custom Change Reasons
- Reporting
- View Related Objects (Object Usage Report)
- Versioning & Deployment
- Casebook Versioning Overview
- Working with Casebook Versions in Studio
- Importing & Exporting a Casebook Definition (ODM)
- Comparing Casebook Versions in Studio
- Creating Study Specifications
- Study Grade
- Deleting Non-production Test Data
- Reference
- CDMS Design Properties Reference
- Tips & Best Practices for Naming Conventions
- Study Update Restrictions
- Publishing Validation Errors & Warnings