Migrate Study Participants
TrialPath
Site CTMS usually migrates participants automatically from the current protocol version to the updated one. However, in some circumstances, the changes required between protocol versions are significant and require manual work to place the participant on the new amendment while maintaining data from previous protocol versions.
User permissions
In order to edit or migrate participants, you must have an access role with these TrialPath permissions set to Edit in Admin:
Permission | Description & Access |
Participant Migrate | Allows users to migrate participants to a new protocol version of a study. |
Participant | Grants access to study participant profiles. |
Best practices
Add cycles
Cycles are supported in the manual migration tool. If the new protocol a participant is migrating to has an infinite cycle, choose Edit Cycle Iterations to increase the number of iterations and to find the next visit. To add a cycle:
From a study, select the participant’s name from the Participant list.
To the bottom right of the visit schedule, click Edit Cycle Iterations.
Then, click the radio button next to the cycle that needs editing.
In the Iterations column, enter the number or use the arrows to find the correct number of iterations.
Once done, click Save Cycle Iterations.
Proceed with the manual migration.
Add events
When a participant is currently on an event (
) reach out to your CEM for assistance with this manual migration.
Handle non-completed visits
Before migrating a participant, check the participant visit schedule to ensure all completed visits on the active protocol visit schedule are marked as Completed, Skipped, or Missed. If working within the manual migration tool, and non-completed visits appear on the Amended Schedule that should be marked as completed, Revert the Migration and resolve any necessary visits. If the Amended visit schedule has missing visits once migration has been completed, follow the steps in the Revert a migration once migration has been completed section.
Handle duplicate visits
If duplicate visits appear in the amended visit schedule once migration has been completed, you can: 1) Mark the duplicate visits as Skipped or 2) Revert the migration to resolve visits to complete the migration.
Migrate participants across protocol versions
After approving a protocol amendment, you can migrate participants to the new protocol version. You can migrate participants from the Protocol Approval slide-out window or from the study Participants list.
View migration history on the participant log
The participant log shows when a participant is migrated from one protocol version to another. This enables you to easily access participant protocol migration history and better understand the current state of the participant visit schedule.
The participant migration record includes the following details for automatic migrations:
Previous protocol version
New protocol version
Date of migration
Migration Type: Automatic
The participant migration record includes the following details for manual migrations:
Previous protocol version
New protocol version
Date of migration
Migration Type: Manual
Starting visit
