The name of the courier responsible for delivery and pick up of LN2 shipper.
Janssen is partnering with this Chinese Biotech to develop this CAR-T treatment.
This is the name a the temperature monitor affixed to the lid of the LN2 shipper.
Sites must have 2 doses of this medication on hand to treat potential cytokine release syndrome
This will be one of Janssen's manufacturing facility locations.
This vendor is used to manage subject and caregiver stipends and to make transportation and hotel arrangements.
____________is the use of very low temperatures to preserve structurally intact living cells and tissues.
The destruction of lymphocytes and T cells, normally by irradiation, prior to CAR-T cell therapy.
2 words. A document designed to provide a complete record of the manufacturing history of a batch of product.
Chain of______ , refers to the chronological documentation or paper trail that allows each therapy to be tracked through the clinical supply chain in real time, providing users with a vein-to-vein view of each therapy’s progress.
Chain of ______ is a process that allows each therapy to be tracked back to the original donor.
Down
2 words. This document outlines the roles and responsibilities of a site's apheresis and cell processing facility and must be finalized before a site can be fully activated.
A procedure in which blood is collected, part of the blood such as platelets or white blood cells is taken out, and the rest of the blood is returned to the donor.
2 words. This person must stay with the patient at all times during the outpatient observation period.
This manual contains instructions for shipping and handling of apheresis and IP. (abbr.)
This document contains instructions on IP preparation and administration. (abbr.)
This is where sites will upload forms associated with traceability.
There are currently 2 approved CAR-T products available commercially. One is Kymriah. Name the other.
The IWRS system used for this trial is:
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