Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9750156
• 负责人: Ashkan Emadi
• 金额: $ 12.48万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9750156
• 关键词: Attention; Baltimore; Biometry; Businesses; Cancer Center; Cancer Center Support Grant; Case Report Form; Cigarette; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Network; County; Data; Data Collection; Data Reporting; Databases; Development; Disease; Doctor of Medicine; Doctor of Philosophy; Enrollment; Ensure; Ethical Review; Event; Exercise; Flow Cytometry; Fruit; Funding; Future; Generations; Genomics; Grant; Hormone Responsive; House Staffs; Human; Human Resources; Image; Industry; Institutes; Institutional Review Boards; Investigational Therapies; Investments; Laboratories; Leadership; Link; Logistics; Malignant Neoplasms; Maryland; Mediation; Medical; Medical center; Molecular Biology; Monitor; Movement; National Clinical Trials Network; Nature; Office Management; Pathology; Patients; Pharmacy Schools; Phase; Population Sciences; Private Sector; Process; Protocols documentation; Public Health Schools; Publications; Recommendation; Reporting; Research; Research Personnel; Research Support; Resources; Role; Safety; School Dentistry; Services; Site; Structure; System; Time; Universities; acronyms; biobank; cancer clinical trial; clinical implementation; college; cost; cost effective; data management; design; experience; high standard; investigator-initiated trial; medical schools; meetings; minimal risk; neoplasm immunotherapy; operation; phase I trial; phase II trial; programs; protocol development; quality assurance; recruit; structural biology; tumor immunology; virology

12.0 Abstract: Clinical Protocol and Data Management The Clinical Protocol and Data Management (CPDM) component of UMGCC comprises the personnel in the Clinical Research Management Office (CRMO), formerly defined as the Clinical Research Shared Service in the 2011 CCSG application, and the resources, including database and technical staff, supporting its operations. The CRMO participates with investigators in the various UMGCC Disease Groups or assists research support staff housed in other departments in UMB, as requested, in the design, review, implementation, monitoring, and reporting of all clinical protocols. This effort includes interactions with the Institutional Review Board (IRB) of UMB, the NCI Central IRB, the Clinical Research Committee (CRC; functioning as the Protocol Review and Monitoring System) of UMGCC, and the UMGCC Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) as well as other monitoring and auditing entities. CRMO utilizes the OnCore database to track enrollment of all patients, completing case report forms for industry- sponsored trials and entering data into appropriate databases for National Clinical Trials Network and Experimental Therapeutics Clinical Trials Network NCI-sponsored studies. During the last granting period encompassing CY2010–2014, the CRMO supported 200–250 protocols/year, resulting in 112 publications. The UMGCC DSM/QAC serves the data safety monitoring function for those protocols that do not have an external data and safety monitoring board (DSMB). The DSM/QAC annually reviews safety information for accrued patients to all “greater than minimal risk” (according to UMB IRB criteria) investigator-initiated trials of any phase, all Phase I trials, and selected industry Phase II trials without a sponsor-appointed DSMB, including multi-institutional investigator-initiated trials for which UMGCC is the coordinating center. During FY2014, costs to support CPDM were $3,159,534, of which $157,278 were from the CCSG. During FY2014, costs to support the DSM/QAC were $776,002, of which $78,500 were from the CCSG.

12.0摘要：临床方案与数据管理