Label Groups
Organize your trial countries by labeling and packaging requirements.
Overview
A label group organizes your trial's countries into sets that share the same labeling — same language, same regulatory format, same production run. Different countries often have different languages, regulatory requirements, and labeling standards. Countries within the same group receive identically labeled kits, which simplifies manufacturing.
Label groups directly affect downstream steps. In Step 7 (Production Constraints), manufacturing runs are tied to label groups. Fewer label groups means fewer separate production runs, reducing complexity and cost.
See Study Setup for an overview of all wizard steps.
Prerequisites
Label groups are built on top of countries configured in Step 1 (Countries and Depots). If no countries exist yet, you will see a prerequisite message prompting you to add countries first.
Creating a Label Group
Click Add Your First Label Group to get started. Each label group has the following fields:
Group Name (Required)
- A short, descriptive name for the label group (max 255 characters)
- Examples: "EU (English)", "German Language", "North America", "Asia-Pacific"
- This name appears on the tab for quick identification
Description (Optional)
- Free-form text for additional notes (max 1,000 characters)
- Use for regulatory context, language details, or special requirements
- Examples: "German language, EU GCP requirements", "English labels for all North American sites"
Assigning Countries
Below the name and description fields, a Countries Assignment section displays all trial countries as selectable chips.
- Click a country to assign it to this label group — it highlights in blue with a checkmark
- Click again to unassign
- Use Select All / Deselect All to quickly assign or clear all countries
- Countries from Step 1 appear automatically
- A country can be assigned to more than one label group if needed (e.g., if a country requires kits with labels in two languages)
Managing Multiple Label Groups
The Tab Interface
Each label group appears as a tab along the top of the editor:
- Click a tab to switch to that group's form
- Tab names update live as you type
- A red dot appears on tabs with validation errors (missing name or no countries)
- Empty names display a default label like "Label Group 1"
Adding More Groups
Click the + button at the end of the tab bar to add a new label group.
Deleting a Label Group
Click the x button on a tab to delete it. A confirmation dialog warns that this action cannot be undone. Countries are unassigned from the group but remain in your trial.
Common Configurations
Single Label Group (Simplest)
When to use: All sites use the same language and regulatory labeling standards.
| Label Group | Countries |
|---|---|
| English Labels | US, UK, Canada, Australia |
One label group means one production run for labeling — minimal manufacturing complexity.
Regional Label Groups
When to use: Your trial spans multiple regulatory regions with different labeling requirements.
| Label Group | Countries |
|---|---|
| North America | US, Canada, Mexico |
| EMEA | Germany, France, UK, Switzerland |
| Asia-Pacific | Australia, Japan, South Korea |
Language-Based Label Groups
When to use: Kits must be labeled in different languages, organized by language rather than geography.
| Label Group | Countries |
|---|---|
| English-Speaking | US, UK, Canada, Australia |
| German-Speaking | Germany, Austria, Switzerland |
| French-Speaking | France, Belgium, Luxembourg |
Mixed Approach
When to use: A combination of regional and language considerations that do not fit one pattern.
| Label Group | Countries |
|---|---|
| English Labels | US, UK, Germany, France |
| French Labels (Quebec) | Canada |
| Japanese Labels | Japan |
Combine regional and language logic as needed. The goal is to minimize the number of groups while ensuring every country gets correctly labeled kits.
Validation
Before continuing to Step 5, the following must be true:
- At least one label group has been created
- Every label group has a name (cannot be blank)
- Every label group has at least one country assigned
- All form fields pass validation (name max 255 characters, description max 1,000 characters)
If any condition is unmet, the Continue button stays disabled. Look for red dots on tabs to identify which groups need attention.
Auto-Save
Changes are saved automatically after about 1.5 seconds of inactivity. The save status indicator shows:
- Saving... — Changes are being saved
- Saved — All changes saved successfully
- Error — Save failed; try making another change or refreshing the page
Auto-save uses relaxed validation — it saves partial progress even if the form is not fully complete. Blank groups (no name, no description, no countries) are skipped.
Tips
- Start with one group per language or regulatory region. Do not overcomplicate your setup from the start.
- Avoid one label group per country unless required. Each group corresponds to a separate manufacturing production run.
- Use descriptive names. Names like "EU (German)" or "North America (English)" are easier to work with than "Group 1", especially when you reach production constraints in Step 7.
- Minimize group count to reduce manufacturing complexity and cost.
- One label group for the entire trial is valid if all sites use the same language and regulatory standards.