Define dynamic resupply strategies

Clinical supply managers can now define a resupply strategy to be dynamic, both when creating a Min/Max and Predictive resupply strategy.

You can now configure a study's supply settings to dynamically resupply and dispense based on the number of active subjects at a site, without entering Oracle Clinical One Platform and manually changing the resupply settings for the site.

The resupply algorithm is enhanced to allow a more dynamic process when defining your study's resupply. This resupply approach:

• Considers subjects that have been either screened or randomized.
• Does not consider subjects assigned a current dose hold.
• Does not consider subjects that have skipped their most recent dispensation visit.
• Deducts from the resupply of subjects that are outside the window of a defined number of days.
• Ensures the site does not become overstocked.
• Minimizes the amount of time supplies require management.

Details for clinical supply managers

As a clinical supply manager, here's what's new for you when defining Min/Max and Predictive resupply strategies:

• The resupply strategy scope can be defined for sites and depots.

  Note:

  The default configuration is set to Site.
• You can choose to apply the predictive resupply rule to subjects once they have been screened or randomized.
• The Subject Filtering Rules setting allows you to exclude subjects from the predictive resupply rule that are on dose hold, have skipped their last dispensation visit, or fall outside of a specified dispensing visit window.
• You can now define and name up to 50 subject count ranges that are applied to different resupply strategies.
• Additionally, you are presented with the Initial Shipment page, where you specify kit types and quantities in one shipment that are sent before resupply begins.
• The Resupply Settings page allows you to set a buffer and manual shipment amount for each subject count range, letting you control the dynamic kit resupply.

  Note:

  This must be defined for each subject count range. These settings can be defined individually for each range, or all together by selecting Bulk Edit.
• Depot-to-depot shipments can only be assigned a Min/Max resupply strategy.
• When defining a minimum and maximum buffer for a predictive resupply, on the Resupply Settings page, you must also specify:
  • Trigger Weeks: The number of weeks it takes for kits to be resupplied.
  • Resupply Weeks: The number of weeks when additional kits must be sent.

More information and step-by-step instructions can be found in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade completes.

Impact on reports

More information and specific descriptions on modified report values can be found in the Reporting Guide after the RAE upgrade completes.

Report	Type of change	Description
Projected Supply (Unblinded) report	New columns	The following columns have been added to this report: Group Name Projected Subject Count
Study Settings report	New and modified tabs	The Resupply Group Configuration tab has been added to this report. The following tabs have been updated in this report: Min/Max Resupply Strategy Predictive Resupply Strategy
Study Settings report	New filter	The Min/Max Resupply Group Configuration has been added to this report under Include in this report filters.

Already working in a live study?

If you're already working in a live study, consider the following notes that apply once this new feature is released:

• The automated resupply algorithm feature can be applied to existing studies.
• When configuring a resupply strategy, on the Resupply Scope page, the Resupply Name field has been updated to Resupply Title.
• Your previously defined resupply settings remain the same for existing studies.