IMP Receipt and Storage Sample Clauses

IMP Receipt and Storage. The NI-0501 vials will be transported with temperature deviation alarms (TempTale 4 or equivalent device), in order to ensure consistent temperatures during transit. When the study drug is received at the site, the Investigator or Pharmacist will check for accurate delivery and absence of temperature deviation alarms. The study drug should be stored between 2-8°C (36 - 46°F). All vials must be stored in a secure locked location in a temperature-controlled refrigerator or cold room. Any deviations from the recommended storage conditions should be immediately reported to the Sponsor and responsible study monitor or contract research organisation (CRO). Affected vials should not be used and should be quarantined until the Sponsor has authorised their use, return or destruction. Documentation of the storage conditions of the study drug must be maintained for the duration of the time the study drug is stored at the site, until such time as it is used, disposed of, or returned to NovImmune or designee. Regular inspections of the NI-0501 vials are required, as detailed in the IMP manual’s directions for the Preparation and Administration of Individual Doses of Study Drug NI-0501.
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