CTEP's Informatics and Computer Support

CTEP 的信息学和计算机支持

• 批准号: 8036360
• 负责人: SUDHIR RAJU
• 金额: $ 811.65万
• 依托单位: CTIS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8036360
• 关键词: Accounting; Address; Authorization documentation; Cancer Therapy Evaluation Program; Clinical; Clinical Data Update System; Clinical Research; Clinical Trials; Common Terminology Criteria for Adverse Events; Communication; Community Clinical Oncology Program; Computers; Confidentiality; Contractor; Data; Development; Electronics; Extensible Markup Language; Extramural Activities; Informatics; Information Systems; Malignant Neoplasms; Monitoring Clinical Trials; Patients; Pharmaceutical Preparations; Process; Protocols documentation; Regulatory Affairs; Reporting; Research Personnel; Safety; Security; Support Contracts; System; Technology; Time; Translating; experience; improved; instrument; operation; protocol development; tool; web page; web-enabled

Cancer Therapy Evaluation Programs Informatics and Computer Support Contract The Cancer Therapy Evaluation Program's Enterprise System (CTEP ESYS) is made up of 22 modules At the present time these modules include but are not limited to: Clinical Trials Monitoring Branch Audit Information System (CTMB-AIS), Protocol Authorization and Tracking System (PATS), Drug Authorization and Review Tracking System (DARTS), Clinical Data Update System (CDUS), Web Enabled CDUS, Common Toxicity Criteria Interactive Tool (CTCAE), Adverse Drug Experience Electronic Reporting Systems (AdEERS), Enterprise Query Wizard (EQW), Financial Instrument and Accrual Tracking System (FIATS), CTEP Account Management System (AMS), Clinical Investigations Branch Information System and Clinical IT (CIBISCIT), Regulatory Affairs Branch Information Tracking System (RABITS), Document Management, Assembly, Review and Tracking System (Docu-MART), and the CTEP Web Page. The primary objectives of the CTEP Enterprise System are to: ¿ Capture data and translate it into a usable format to address the scientific, safety, regulatory and administrative needs of CTEP and the NCI. ¿ Eliminate data redundancy throughout the oncology community ¿ Streamline clinical research operations. ¿ Reduce the administrative burden on NCI staff, contractors, and extramural researchers. ¿ Improve communication between CTEP and its collaborators. ¿ Assure the security and confidentiality of proprietary and patient information. ¿ Increase access to clinical trials to all investigators ¿ Capitalize on XML and other technologies to maximize reusability and integration with other systems in the oncology community. ¿ Support broad patient access to clinical trials. ¿ Expedite the protocol development and review process within both clinical trial organizations and reviewing bodies

癌症治疗评估计划信息学和计算机支持合同 癌症治疗评估计划的企业系统（CTEP ESYS）由22个模块组成，目前这些模块包括但不限于：临床试验监查分支稽查信息系统（CTMB-AIS）、方案授权和跟踪系统（PATS）、药物授权和审查跟踪系统（DARTS）、临床数据更新系统（CDUS）、网络启用CDUS，通用毒性标准交互工具（CTCAE）、药物不良反应电子报告系统（AdEERS）、企业查询向导（EQW）、金融工具和应计跟踪系统（FIATS）、CTEP账户管理系统（AMS）、临床研究分支信息系统和临床IT（CIBISCIT）、法规事务分支信息跟踪系统（RABITS）、文件管理、组装、审查和跟踪系统（Docu-MART）和CTEP网页。CTEP企业系统的主要目标是：捕获数据并将其转换为可用的格式，以满足CTEP和NCI的科学，安全，监管和管理需求。<$消除整个肿瘤学界的数据冗余<$简化临床研究操作。减少NCI工作人员，承包商和校外研究人员的行政负担。改善CTEP及其合作者之间的沟通。确保专有信息和患者信息的安全性和机密性。<$增加所有研究者对临床试验的访问<$利用XML和其他技术，最大限度地提高可重用性，并与肿瘤学界的其他系统集成。支持广泛的患者进入临床试验。加快临床试验组织和审查机构内的方案制定和审查过程