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.

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To see how this may be used in practice, we can follow some examples.

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.

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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.

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Users must be aware that selecting the ‘Include Collected Samples?’ setting during synchronization will remove all processed steps for existing samples. This occurs in an audited fashion. Once finished, those samples will go back to their original collected state and return for processing within the Samples > Processing area.

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.