Preparation/Handling Sample Clauses

Preparation/Handling. Storage/Accountability
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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.
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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.
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Related to Preparation/Handling

  • Preparation Awarded vendor shall not begin a project for which TIPS Member has not prepared the site, unless awarded vendor does the preparation work at no cost, or until TIPS Member includes the cost of site preparation in a purchase order. Site preparation includes, but is not limited to: moving furniture, installing wiring for networks or power, and similar pre-installation requirements. Registered sex offender restrictions: For work to be performed at schools, awarded vendor agrees that no employee of a sub-contractor who has been adjudicated to be a registered sex offender will perform work at any time when students are, or reasonably expected to be, present. Awarded vendor agrees that a violation of this condition shall be considered a material breach and may result in the cancellation of the purchase order at the TIPS Member’s discretion. Awarded vendor must identify any additional costs associated with compliance of this term. If no costs are specified, compliance with this term will be provided at no additional charge. Safety measures: Awarded vendor shall take all reasonable precautions for the safety of employees on the worksite, and shall erect and properly maintain all necessary safeguards for protection of workers and the public. Awarded vendor shall post warning signs against all hazards created by the operation and work in progress. Proper precautions shall be taken pursuant to state law and standard practices to protect workers, general public and existing structures from injury or damage.

  • Joint Preparation The preparation of this Agreement has been a joint effort of the parties and the resulting documents shall not, solely as a matter of judicial construction, be construed more severely against one of the parties than the other.

  • Preparation; Reasonable Investigation In connection with the ------------------------------------- preparation and filing of each registration statement under the Securities Act pursuant to this Agreement, the Company will give the holders of Registrable Securities registered under such registration statement, their underwriters, if any, and their respective counsel and accountants, the opportunity to participate in the preparation of such registration statement, each prospectus included therein or filed with the Commission, and each amendment thereof or supplement thereto, and will give each of them such access to its books and records and such opportunities to discuss the business of the Company with its officers and the independent public accountants who have certified its financial statements as shall be necessary, in the opinion of such holders' and such underwriters' respective counsel, to conduct a reasonable investigation within the meaning of the Securities Act.

  • Preparation Period During the preparation period, a teacher will have no other assignment except in an emergency situation. It is recognized that the preparation period is a scheduled part of the teacher's work day and the teacher is expected to be in his/her respective Building. If the teacher must leave the Building during his/her preparation and/or lunch period, he/she must notify the Building switchboard operator.

  • Preparation Time 1. Each full-time elementary teacher shall receive 100 minutes of preparation time per week scheduled in accordance with the Previous Collective Agreement. 2. Effective June 30, 2019, each full-time elementary teacher shall receive 110 minutes of preparation time per week scheduled in accordance with the Previous Collective Agreement. 3. Preparation time for part time teachers shall be provided in accordance with the Previous Collective Agreement.