Latin American Breast Cancer Pilot

拉丁美洲乳腺癌试点

• 批准号: 8654819
• 负责人: DAVID HEIMBROOK
• 金额: $ 307.5万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-26 至 2018-09-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8654819
• 关键词: Accounting; Address; Adherence; Advanced Technology Center; Agreement; American; Argentina; Brazil; Businesses; Chile; Clinical; Clinical Protocols; Clinical Research; Clinical Trials Network; Collaborations; Consent; Constitution; Contractor; Contracts; Country; Data; Data Quality; Development; Doctor of Medicine; Doctor of Philosophy; Ensure; Ethics Committees; Evaluation; Funding; Goals; Government Agencies; Institutional Review Boards; International; Latin America; Leadership; Mexico; Mission; Modeling; Monitor; Notification; Office for Human Research Protections; Performance; Pilot Projects; Process; Progress Reports; Protocols documentation; Quality Control; Regulation; Report (account); Reporting; Research; Research Personnel; Risk; Safety; Science; Site; Strategic Planning; System; Training Programs; Uruguay; Work; anticancer research; base; evidence base; experience; human subject protection; malignant breast neoplasm; multidisciplinary; payment; quality assurance

The OLACPD was launched in 2008 to advance the mission of NCI by collaborating with government agencies, researchers, and organizations to further cancer research in Latin American countries. Under the leadership of Jorge Gomez, M.D., Ph.D., OLACPD has developed a strategic research plan for Latin America to increase capability of these countries to participate and partner in cancer research through development of needed clinical trials networks, the enhancement of advanced technology centers, and development of multinational and multidisciplinary training programs. The proposed plan intends to continue funding of the breast cancer pilot study based on the model presented in the OLACPD Strategic Plan for Latin America and addressed in the implementation plan described below. Implementation Plan for funding the Breast Cancer Pilot Study by OLACPD and five Latin American countries (Argentina, Brazil, Chile, Mexico, and Uruguay): In coordination with SAIC-Frederick, OLACPD has developed a business model that adheres to the following principles: 1. Utilizing the contract mechanism. This mechanism was selected to minimize potential risks to the NCI and to provide the means to assess progress and confer project management responsibility of the pilot study. a. Based on SOW developed by OLACPD and SAIC, contractual agreements have been issued for the first year and renew on a yearly basis (based on progress report). b. Payments will be released every six months allowing NCI and contracting officers to evaluate progress and performance on a regular basis; and, identify under-performers. Should the latter condition exist, stop payment action will occur if necessary. 2. Appropriate utilization of funds. The contracting officers at SAIC-Frederick have excellent experience in oversight and reviewing accounting practices in the international setting. a. An appropriate accounting and reporting system is in place by SAIC contracting office to maintain and confirm the appropriate utilization of funds. 3. Adherence to Statement of Work (SOW). The SOW customized for each country incorporates the terms and conditions agreed upon and consented for the conduct of the breast cancer pilot study. a. NCI and its contractors (SAIC and CCSA acting as the CRO) will continue to closely monitor progress of the project, including adherence to protocol, accrual, quality control and assurance, as well as auditing of the sites when necessary. i. SAIC-Frederick is responsible to the NCI for establishing and maintaining the contracts for OLACPD, notification of deliverables, providing project management, and, reporting and invoicing of the US-LACRN business activities under this clinical protocol. ii. CCSA is responsible for carrying out scientific management and programmatic aspects for the NCI. 4. Adherence to the Office of Human Research Protections. The breast cancer pilot study is supported by the NCI and as such, the US-LACRN must ensure compliance to the rules and regulations including Federal Wide Assurances, constitution of IRBs (or Ethics Committees), and other activities. a. An independent Data Safety and Monitoring Committee (DSMC) is being formed to ensure the quality of the data, and safeguard the protection of human subjects participating in research. The NCI will be represented on this committee. 5. Clinical Study Progress Appraisal. An evaluation process will be developed in order to assess progress at the institutional level in each country taking into consideration the scientific goals and the operational implementation of the pilot study.

OLACPD于2008年启动，以通过与政府机构，研究人员和组织合作进一步在拉丁美洲国家进行癌症研究来推进NCI的任务。在豪尔赫·戈麦斯（Jorge Gomez，M.D. 拟议的计划旨在根据OLACPD拉丁美洲战略计划中提出的模型继续资助乳腺癌试点研究，并在下面介绍的实施计划中解决。 OLACPD和五个拉丁美洲国家（阿根廷，巴西，智利，墨西哥和乌拉圭）为乳腺癌试点研究提供资金的实施计划：与Saic-Frederick协调，OLACPD开发了一种遵守以下原则的商业模式： 1。利用合同机制。选择这种机制来最大程度地降低NCI的潜在风险，并提供评估试点研究的进度并赋予项目管理责任的手段。 一个。根据OLACPD和SAIC开发的SOW，第一年就发布了合同协议，并每年续签（基于进度报告）。 b。付款将每六个月发布一次，允许NCI和承包官员定期评估进度和绩效；并确定表现不佳的人。如果存在后一种条件，则需要在必要时进行停止付款诉讼。 2。适当利用资金。 Saic-Frederick的承包官在监督和审查国际环境中的会计惯例方面具有良好的经验。 一个。 SAIC合同办公室建立了适当的会计和报告系统，以维护和确认适当利用资金。 3。坚持工作声明（SOW）。为每个国家 /地区定制的母猪纳入了乳腺癌试点研究的同意并同意的条款和条件。 一个。 NCI及其承包商（SAIC和CCSA充当CRO）将继续密切监视项目的进度，包括遵守协议，应计，质量控制和保证，以及必要时对网站的审核。 我。 Saic-Frederick对NCI负责确定和维护OLACPD的合同，可交付成果的通知，提供项目管理以及根据此临床协议的美国LACRN业务活动的报告和开票。 ii。 CCSA负责为NCI进行科学管理和程序化方面。 4。遵守人类研究保护办公室。乳腺癌试点研究得到了NCI的支持，因此，美国湖人必须确保遵守法规，包括联邦广泛的保证，IRB宪法（或伦理委员会）和其他活动。 一个。正在形成一个独立的数据安全和监测委员会（DSMC），以确保数据的质量，并保护参与研究的人类受试者。 NCI将代表该委员会。 5。临床研究进度评估。将开发一个评估过程，以评估每个国家 /地区在机构层面上的进展，考虑到试点研究的科学目标和运营实施。