Testing guidelines for mid-study RTSM changes

When you make RTSM related changes during a live study (such as updating treatment arms, randomization, kits, or re-configuring resupply strategies), always verify that the changes work correctly before moving the new version into Production.

WARNING:

Treat every RTSM related mid-study change as potentially impacting dispensation, resupply, or randomization processes. Verification steps reduce the risk of runtime issues, such as missing buttons or kit allocation errors.

Use the following guidelines to minimize disruptions in your subjects' dispensation schedule.

Randomization and design lists

• Confirm that the correct randomization design is still assigned to the appropriate visits.
• If you create or upload a new randomization list, verify the following:
  • Numbers in the new list don’t overlap with those in the existing list.
  • The list doesn’t reference treatment arms that were removed.
• Run test randomization in Testing mode to confirm both new and existing subjects can still be assigned correctly.

Kit lists

• Check that all kit types required for dispensation are included in the new study version.
• Ensure kit list numbers don’t overlap with previous lists.
• Generate a kit list that's in accordance to your newly updated dispensation.
• In Testing mode, start subject visits to verify that dispensation actions are still available.

Resupply strategies

• Review your associated resupply strategies after creating a new study version, and ensure that they're properly assigned to each site.
• Confirm thresholds are still active and correctly applied (such as the minimum or maximum buffer of a predictive resupply strategy).
• Validate that resupply runs as expected in Testing mode before go-live.

Dose hold and dispensation

• Confirm dose holds are still active for the appropriate visits where they were configured.
• Verify that dispensation actions appear as expected at each visit.
• Use reports, such as the Subject Visits or Study Design reports to confirm that ongoing subjects aren’t missing dose hold or dispensation options.

General guidelines

• Always run regression checks in Testing mode with both:
  • New subjects - to confirm the updated dispensation or supply design works correctly).
  • Active (existing) subjects - to confirm continuity and that changes are preserved between study versions.
• Document any RTSM related change (kit configuration, randomization, dose hold, resupply, etc.) and validate its downstream impact before approving the study version for Production. Check how it's displayed in reports, data sets, or other integrations - if possible.