Clinical Research - Investigational Medicinal Product (IMP) Temperature Monitoring

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Document Purpose

The purpose of this procedure is to ensure that the quality and integrity of IMP is maintained in compliance with NSW Health, SCHN, regulatory and Protocol requirements through the monitoring of temperature in locations used for the storage IMP for clinical research. Adherence to this procedure will ensure that: * A valid, continuous record of temperature is available for all locations used for the storage of IMP for clinical research; and * Temperature deviations are promptly identified, escalated and acted upon, as appropriate, in consultation with the Sponsor or Delegate.

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