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An alarm is evidence to investigate, not a conclusion about product suitability. Türkiye research sites need an agreed path from detecting a temperature excursion to an authorized, traceable disposition decision.
Contain the affected stock
Use the study's product instructions and the applicable TİTCK good clinical practice framework to assign responsibilities. Separate immediate containment from the technical stability assessment. A site's ambient temperature reading cannot replace the shipment or storage evidence needed to understand the affected stock's actual exposure.
Build a usable excursion record
We recommend an excursion record containing time boundaries, logger identifier, calibration status, affected kit identifiers and storage history. Preserve original logger files. The authorized product quality function should receive sufficient evidence to assess disposition; the investigator separately assesses any implications for participants who may already have received affected product.
Reconcile the evidence
- Quarantine affected units and prevent dispensing while their status remains unresolved.
- Record duration, observed limits, equipment details and any missing logger data.
- Obtain the authorized written disposition with its scientific basis and stock scope.
- Reconcile replacement supply, participant follow-up and applicable reporting assessments.
Resolve clinical consequences
Do not turn a one-time acceptance into a new storage range. Investigate equipment, transport and alarm-response causes, then verify the corrective action. File the decision with accountability records so a later monitor can identify exactly which units were released, returned or destroyed.
Frequently asked questions
- Does quarantine automatically mean destruction?
- No. Quarantine protects against premature use while an authorized assessment determines disposition.
- Can the site average out an out-of-range reading?
- Do not replace the exposure history with an average. Preserve the original evidence for the product-specific assessment.