- Published
- Updated
Delivery to a site does not establish which participant received which device. Linking serial, lot and configuration information correctly to clinical records supports technical investigation, recall assessment and interpretation of study outcomes.
Define the assessment
Define receipt, release from stock, use, unused return and destruction as different movements. When using participant study codes, keep the authorised linkage key appropriately protected. Decide whether unit-level or lot-level tracking is needed from the characteristics of the device rather than assuming all products require identical records.
Worked example
For example, a site opens two packages from one lot on the same day and transposes their serial numbers in the electronic form. The team compares procedure notes, package labels and stock movements instead of treating an invoice as evidence of the correction. If the exact match remains uncertain, it records that uncertainty and assesses its safety implications.
Practical checks
- Reconcile quantities received, used, returned and left unused through clearly defined movements.
- Apply scanning or independent verification where serial identifiers are copied manually between records.
- Link replacement devices to the participant timeline without deleting the previous unit record.
Decision and limitations
The trace should let a reviewer find the use of a particular device and unresolved matching issues. Never assign a guessed identifier retrospectively. Preserve the old value, correction source and authorised decision; unknown information should not enter the report as an established fact.
Frequently asked questions
- Is an invoice sufficient for traceability?
- It usually explains delivery. Application records are still needed to establish which actual unit was used for a participant.
- What if an exact match cannot be found?
- Document the uncertainty, identify affected records and assess safety and analytical consequences with the responsible reviewers.