Milestones and Timeline

Workflows in Study Hub help you track progress through defined processes. Each workflow contains milestones (steps) with target or completion dates.

Understanding Workflows

A workflow is a series of steps that represent a process:

• Workflow - A defined process (e.g., "Regulatory Approval", "Study Setup")
• Steps/Milestones - Individual stages within the workflow
• Dates - Target or completion dates for each step

Viewing Workflow Progress

In the Studies List

Each study row shows a progress indicator:

• Progress bar - Visual representation of completion
• Step count - "X/Y steps" completed
• Percentage - How much of the workflow is done

In Study Details

To see detailed milestone information:

1. Go to All Studies in the sidebar
2. Click Details on the study row to open the study
3. Click the Workflows tab (second tab, between Overview and Details)
4. View each workflow assigned to the study
5. See all steps with their dates and status

Step Information

Each workflow step displays:

Field	Description
Name	Step title/description
Date	Target or completion date
Status	Complete, pending, or skipped
Visibility	External (Ext) or Internal (Int)

Updating Milestone Dates

To Set or Change a Date

1. Open the study
2. Navigate to the workflow section
3. Find the step you want to update
4. Click on the date field
5. Select or type the new date
6. Save your changes

Date Entry

• Use the date picker or type in YYYY-MM-DD format
• Dates can be in the past (completed) or future (target)
• Leave blank if unknown or not applicable

Skipping Steps

Some steps may not apply to every study:

1. Find the step to skip
2. Mark it as "Skipped" or "N/A"
3. Skipped steps don't count toward completion percentage
4. Save your changes

Marking Delays

You can mark workflows or individual steps as "delayed" to track sponsor-side or other external delays that are outside your site's control.

Why Track Delays?

• Distinguish between internal processing time and external hold periods
• Document when and why delays occurred
• Provide clear audit trail for regulatory or sponsor inquiries
• Help with accurate timeline reporting

To Mark a Workflow or Step as Delayed

1. Open the study and navigate to the workflow
2. Find the workflow or step you want to mark
3. Click the Delay toggle or button
4. The item is marked as delayed with a visual indicator

Adding Delay Notes

When marking something as delayed:

1. Toggle the delay status on
2. Add a start note explaining why the delay began
3. When the delay ends, toggle the delay off
4. Add an end note documenting when and why it resolved

Delay Use Cases

Scenario	Action
Sponsor hasn't provided materials	Mark workflow/step as delayed, note "Awaiting sponsor materials"
Regulatory hold from external body	Mark as delayed, document the hold reason
Third-party vendor delay	Mark as delayed until vendor delivers
Internal delay	Generally don't use delay—update dates or add notes instead

TIP

Use delay tracking for external factors only. For internal delays, simply update milestone dates and add explanatory notes.

Step Ordering

Steps within a workflow are ordered by their relative timepoints:

• Steps appear in logical process order
• Earlier steps appear first
• This helps you work through the process sequentially

Multiple Workflows

Studies can have multiple workflows:

• Each workflow tracks a different process
• Workflows appear as separate sections
• Progress is tracked independently for each
• Overall study progress may combine all workflows

Workflow Instances

Studies can have multiple instances of the same workflow type, useful when a process needs to run more than once.

When to Use Multiple Instances

• Amendment cycles - Each amendment gets its own workflow instance
• Re-submissions - Track each submission attempt separately
• Parallel processes - Run the same workflow for different sub-studies or cohorts

Adding a Workflow Instance

1. Open the study's Workflows tab
2. Find the workflow type you want to add
3. Click Add Instance (or similar)
4. A new instance is created with its own set of dates

Managing Multiple Instances

• Each instance tracks dates independently
• Progress is calculated across all instances
• Charts and timelines display all instances accurately
• You can view instances individually or see aggregate progress

Timeline Visualization

Role Required

Timeline visualization in the Metrics dashboard requires appropriate role access.

If you have access to Metrics, you can see:

• Gantt chart - Visual timeline of milestones
• Process flow - Diagram showing workflow structure
• Timeline panel - Detailed milestone tracking

See Metrics Dashboard for more information.

Progress Calculation

Progress is calculated as:

Progress = (Completed Steps + Skipped Steps) / Total Steps × 100%

• Steps with dates in the past are typically considered complete
• Skipped steps count as complete for progress purposes
• Empty dates count as incomplete

Best Practices

• Set realistic dates - Use achievable target dates
• Update promptly - Mark steps complete when they're done
• Use skip appropriately - Only skip truly non-applicable steps
• Review regularly - Keep milestones current for accurate reporting
• Document delays - Add notes when milestones are missed