TAS::75 0872::TAS SMARTT (11-8470187)

必要时作为SMARTT指导委员会和小组委员会的成员参加， 为整个SMARTT计划提供输入。（第3.0节） 协助创建cGMP和GLP级程序手册（MOP），并更新为 在生产阶段（SMARTT第二阶段）。（第2.3.1节） 根据NHLBI和 CC.（2.3.2.1部分） 协助制定服务请求的评价、优先排序和处理程序 应用程序（登记册系统管理人）。（参见2.3.2.2）然后将在生产阶段使用这些程序， 评估每个RSA，包括完成可行性评估（FA）。（2.3.2.3部分） 对协调中心客户满意度调查的设计和内容作出贡献 （第2.3.2.5节）、营销计划（第2.3.4节）、公共和私人网站（第2.3.3节）以及 用于跟踪整个生产过程中所有生物制剂和数据的电子数据库。ABL的计算机 还描述了系统能力。（第4.2节）。 作为美国FDA定义的cGMP生产部门为生物治疗产品提供服务。 处理、分析（第2.3.5节）、储存和运输生产的产品（第4.1.2节）。 向研究者提供翻译支持或生产服务，并提供所需的生物治疗 产品.（第2.3.5节） 向NHLBI PO和CO提供半年度生产报告（第2.3.2.4部分），同时不断 维护生产非临床和临床产品所需的所有认证和要求; 所有数据都可用于CC每年的现场访问。设计和执行监测计划， 产品，包括生产和遵守法规要求。（第2.3.6节） 维护所有生物制品的质量控制和质量保证计划。（第2.3.6节） 对于每个制造的产品，提供完整的方案信息，包括质量控制和 质量保证程序（根据MOP）和各批次存档样品的制备 制造的。（第2.3.6节） 在合同的最后几个月，提供有序的收尾和终止服务协议。 （2.3.2.6部分）

Participation as a member of the SMARTT Steering Committee (SC) and subcommittees as necessary to provide input to the overall SMARTT program. (Section 3.0) Contribution to the creation of a cGMP- and GLP-grade manual of procedures (MOP) with updates as necessary during the production phase (SMARTT Phase II). (Section 2.3.1) Development and implementation of Material Transfer Agreements (MTA) with input from NHLBI and the CC. (Section 2.3.2.1) Contribution to developing procedures for evaluating, prioritizing and processing Request for Services Applications (RSAs). (Section 2.3.2.2) These procedures will then be utilized in the production phase to evaluate each RSA, including completion of a Feasibility Assessment (FA). (Section 2.3.2.3) Contribution to the design and content of the Coordinating Center's (CC) customer satisfaction survey (Section 2.3.2.5), marketing plan (Section 2.3.4), public and private websites (Section 2.3.3), and the electronic database for tracking all biologics and data throughout the production process. ABL's computer system capabilities are also described. (Section 4.2) . Provision of services as a US FDA-defined cGMP production faculty for biological therapy products. Processing, analyzing (Section 2.3 .5), storing, and shipping products (Section 4.1.2) produced. Provision of translational support or manufacturing services to Investigators with requested biological therapy products. (Section 2.3.5) Provision of semi-annual production reports to the NHLBI PO and CO (Section 2.3.2.4), while constantly maintaining all required certifications and requirements to manufacture both nonclinical and clinical products; all data is available for the yearly site visits by the CC. Design and implementation of monitoring plans for products, including production and compliance with regulatory requirements. (Section 2.3.6) Maintenance of quality control and quality assurance plans for all biologics products. (Section 2.3.6) For each manufactured product, provision of complete protocol information, including quality control and quality assurance procedures, in accordance with the MOP, and preparation of archival samples from each lot manufactured. (Section 2.3.6) Provision of orderly closeout and termination of service agreements during the final months of the contract. (Section 2.3.2.6)