Preparation/Handling. Storage/Accountability At the pharmacy, ALXN2050 capsules and tablets must be stored as provided in containers at controlled room temperature (20°C to 25°C). Patients should be instructed to keep their study medications in the original container at room temperature. The PI or designee (eg, pharmacist) is responsible for ensuring storage as per the label on the drug product at the site and adequate accountability of all used and unused study medication. This includes acknowledgment of receipt of each shipment of study medication (quantity and condition), patient dispensing records, and returned or destroyed drug. Dispensing records will document quantities received from the Sponsor and quantities dispensed to patients, including lot number, date dispensed, and patient identifier number. All drug supplies and associated documentation will be periodically reviewed and verified by the study monitor over the course of the study. Storage condition details for the drug product are described in the Pharmacy Manual provided by the Sponsor. Handling and storage conditions of capsules and tablets are identical.
Preparation/Handling. Storage/Accountability
Preparation/Handling. Storage/Accountability
1. The Investigator or designee must confirm appropriate temperature conditions have been maintained during transit for all study intervention received and any discrepancies are reported and resolved before use of the study intervention.
a. The ALXN1840 treatment kits should be stored at refrigerated conditions, 2°C to 8°C (36°F to 46°F).
2. Only participants enrolled in the study may receive the study intervention and only authorized site staff may supply or administer the study intervention. All study intervention must be stored in a secure, environmentally controlled, and monitored (manual or automated) area in accordance with the labeled storage conditions with access limited to the Investigator and authorized site staff.
3. The Investigator and/or qualified delegate (ie, Pharmacist) is responsible for study intervention accountability, reconciliation, and record maintenance (ie, receipt, reconciliation, and final disposition records).
a. This responsibility includes the reporting of any product complaints to PPD within 1 business day. A product complaint is defined as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety, effectiveness, or performance of a product or clinical trial material and/or its packaging components after it is has been released for distribution to an end customer that affects the performance of such product.
4. Further guidance and information for the final disposition of unused study interventions are provided in the Pharmacy Manual.
