Summary

ClinSpark takes a very conservative approach to modifications that need to be made to locked sample path configurations. This is due to the implications that pathway changes have to barcodes, samples waiting to be collected against an activated activity plan, and collected samples that are still being processed under their original pathway. However, sometimes there are scenarios related to protocol or lab manual changes that must address structural changes to sample pathways after they’ve been made part of an activated activity plan.

Synchronize Samples

Within a sample path configuration, there is a ‘Synchronize Samples’ feature which is designed to allow sites a way to recover from and adapt to late minute sample path changes. Under synchronization scenarios, all transfer barcodes related to the updated sample path must be reprinted. Sites must react to this depending on their operational workflows for barcode printing. Some sites chose to print these barcodes ahead of time, while others do-so at time of collection.

Open

Open

This feature contains help text to guide users through the process. Additionally, the feature was designed with some standard assumptions:

• This action is reserved for when structural changes have been applied to the sample path after activity plan activation.

• This action is only available to users once a sample path has been put into a locked state.

• This action will recreate new barcodes for each transfer step.

• Upon synchronization, an audit is stored for each relevant sample, and the event is audited with the given sample path.

• If the ‘Include Collected Samples’ option is chosen, all processed steps for the relevant samples will be removed.

• If the ‘Recreated Sample Data Items?’ option is unchecked, the sample path data items will not be recreated immediately. This is useful when if a path will be unlocked and steps will be removed.

Changes That Require Sample Path Synchronization

When structural changes are made to a sample processing path, those changes can be pushed through to uncollected samples for already-active cohort assignments These changes include:

1. Sample Path Settings

   1. Editing Specimen Containers

      1. Applies to uncollected samples

      2. Barcode labels may need to be reprinted, as barcode numbers may change

2. Step Settings

   1. Adding New Steps

      1. Applies to uncollected samples and collected samples which have not yet encountered the added step(s)

3. Transfer Material Settings

   1. Editing Transfer Material Specimen Containers

      1. Applies to uncollected samples

      2. Barcode labels may need to be reprinted, as barcode numbers may change

4. Adding New Transfer Materials

   1. Applies to uncollected samples

Changes That Do Not Require Sample Path Synchronization

The following basic changes can be made to a sample processing path without requiring synchronization of the path:

1. Sample Path Settings

   1. Editing Sample Path Name

      1. Applies to uncollected, collected, and fully processed samples

2. Step Settings

   1. Adding/Removing/Changing Device Requirements on Steps

      1. Applies to uncollected samples and collected samples which have not yet encountered the edited device step

   2. Editing Step Timing

      1. The timing must not exceed the timing of the step proceeding the edited step

      2. Applies to uncollected samples and collected samples which have not yet encountered the edited step

   3. Editing Step Deviation Windows

      1. Applies to uncollected samples and collected samples which have not yet encountered the edited step

   4. Editing Step Warning/Urgent Seconds

      1. Applies to uncollected samples and collected samples which have not yet encountered the edited step

   5. Editing Step Instructions

      1. Applies to uncollected samples and collected samples which have not yet encountered the edited step

   6. Adding New Steps

      1. Applies only to new Cohort Assignment activations, all previous cohort activiations will not be impacted unless the path is synchronized

3. Transfer Material Settings

   1. Editing Transfer Material Name

      1. Applies to uncollected, collected, and fully processed samples

   2. Editing Transfer Material Instructions

      1. Applies to uncollected samples and collected samples which have not yet encountered the edited step

   3. Editing Transfer Material External Barcode Requirements

      1. Applies to uncollected samples and collected samples which have not yet encountered the edited step

   4. Adding New Transfer Materials

      1. Applies only to new Cohort Assignment activations, all previous cohort activations will not be impacted unless the path is synchronized

4. Associating a New Sample Path with an Item

   1. Applies only to new Cohort Assignment activations

Example Scenarios

Now let’s see how this may be used in practice, we can follow some scenarios:

Scenario 1 - Modifying Steps from a Sample Path & Recreating Sample Data

Let’s assume that a trial has begun with sample collection done against a locked path configuration. Some samples have already been processed for that study, while others are awaiting collection/processing. However, a structural change needs to be made where sample transfer tasks need to be removed from an existing pathway. Those structural changes need to propagate over to the samples waiting to be collected against already activated activity plans.

Users may attempt to address this first by unlocking the path, and then selecting the ‘delete’ action for each task. However, an error message may be presented…

When this error states that the sample transfers are currently in use, it means that the pathways for those samples have already been built out based on the current sample path configuration when the form was created (during plan activation), and cannot be modified in their current state. This can be verified by looking at those existing sample collection timepoints within Samples > Manage.

Additionally, there may still be collected samples already being processed against the original pathway. By design, ClinSpark enforces that those samples:

• finish their processing under the original pathway, or

• be removed (cancelled) by the user, or

• go through a synchronization and be reprocessed again (see Scenario 2 below).

With the need to now modify the path configuration, a site should decide to copy the original pathway and make a second version. That new path configuration (version 2) is now replaced as the new sample path to the form via CRF design. Sites would make all applicable changes to the sample path, and place the path into a locked state. Once that is done, the following can occur:

• Link the new sample path to the applicable collection form (via CRF design).

• Within the approved second version of the sample path, within the action menu, select the ‘Synchronize Samples’ feature.

• Ensure that ‘Recreate Sample Data Items?’ is selected. Note: In this example scenario, a user would NOT select ‘Include Collected Samples?’, as this will remove all processed steps for existing samples.

• Apply a reason for change, then save.

• Within Samples > Manage, locate all existing samples that reference the approved second version of the sample path, and confirm that the pathways on the samples ready to be collected are now setup with correct transfer tasks.

When using the ‘Synchronize Samples’ features in this use case, all changes to those existing collection timepoints are made in an audited fashion. Further, any previously printed transfer barcodes related to the sample path must be re-printed.

Scenario 2 - Reprocess Collected Samples

Under rare scenarios, it may be necessary to entirely reprocess samples that have already been collected against a particular pathway. The synchronization feature can support this need whether or not structural changes have happened to the pathway in question.

Users must be aware that selecting the ‘Include Collected Samples?’ setting during synchronization will remove all processed steps for existing samples and be recreated in the Samples > Processing module for reprocessing. Therefore, the ‘Include Collected Samples’ checkbox should be used with extreme caution. Note: an audit trail will be maintained in the Samples > Manage module for already-processed samples, thereby maintaining access to the ‘original’ processing details even after this style of synchronization.

In addition, samples which have been packaged into containers in the Samples > Packaging module will be removed from their containers upon performing this style of synchronization. However, samples which have already been shipped will remain unaffected by this style of synchronization.

Recommended Testing of Synchronized Changes

Due to the implications this feature has to sample processing data integrity, it’s recommended to try this feature set first in a TEST environment in a controlled manner. Staging the current pathway configuration, changes, and expected results against mock data is the best way to see if desired results are met.