DATA SAFETY AND MONITORING BOARD

数据安全和监控委员会

基本信息

批准号：
8181025
负责人：
SUSAN M. BLANEY
金额：
$ 4.21万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-17 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8181025
关键词：
Address Adherence Adult Adverse event Affect Ambulatory Care Amendment American College of Surgeons Oncology Group Area Attention Behavioral Behavioral Research Biology Blinded Cancer Center Cancer Trials Support Unit Categories Cells Childhood Clinical Research Clinical Research Associate Clinical Trials Clinical Trials Data Monitoring Committees Committee Members Conduct Clinical Trials Confidentiality Conflict (Psychology)Conflict of Interest Constitution Coupled Data Data Collection Data Quality Databases Development Diagnostic and Statistical Manual Disclosure Dose Drug Industry Electronics Eligibility Determination Employee Enrollment Ensure Environment Epidemiology Ethical Review Evaluation Event FDA approved Faculty Frequencies Funding Future Genetic Materials Good Clinical Practice Grant Guidelines Hospitals Image Individual Institution International Intervention Late Effects Lead Leadership Maintenance Malignant Neoplasms Manuscripts Masks Measures Medical Medicine Mission Modification Monitor NCI-Designated Cancer Center National Surgical Adjuvant Breast and Bowel Project Notification Nursing Research Nutritional Outcome Outcome Measure Participant Patients Peer Review Persons Pharmacologic Substance Phase Phase I Clinical Trials Placebo Control Policies Preparation Principal Investigator Procedures Process Protocol Compliance Protocols documentation Published Comment Quality Control Quality of life Randomized Recommendation Regulation Reporting Research Research Design Research Ethics Committees Research Infrastructure Research Personnel Resources Rest Review Committee Risk Role Safety Schedule Source Southwest Oncology Group Standardization Structure Suspension substance Suspensions Teleconferences Therapeutic Time Toxic effect Training Voting Writing arm base cancer prevention cancer research center director college computerized data processing data format design gene therapy high risk improved meetings member patient safety primary outcome programs quality assurance research study response risk benefit ratio symposium

项目摘要

The Dan L Duncan Cancer Center (DLDCC) places the highest priority on ensuring the safety of patients participating in clinical trials. The Principal Investigator (PI) has primary responsibility for oversight, but additional safety measures include integrated scientific, safety and ethical review and monitoring coupled with quality assurance audits. The primary oversight of clinical research conducted at DLDCC as related to the Initiation, monitoring and termination of clinical trials Is overseen by (1) the Protocol Review and Monitoring Committee (PRMC), (2) Data Review Committees (DRC); and (3) a Patient Safety Officer (PSO) who ensures that all data monitoring for Cancer Center trials is conducted in accordance with the approved monitoring plan. Each DLDCC protocol must have a data and safety monitoring plan, which is reviewed and approved by the PRMC prior to patient enrollment. Protocol monitoring for DLDCC protocols may be accomplished by several mechanisms Including: NCI Cooperative Group data and safety review committees, medical monitors or committees established by a pharmaceutical or academic sponsor, DLDCC standing Data Review Committees or by individual, protocol-specific Data and Safety Monitoring Boards. The committees, and the PSO, report to the Clinical Research Leadership Committee within the DLDCC and ultimately to the Cancer Center Director.

丹·L·邓肯癌症中心 (DLDCC) 将确保患者的安全放在首位参与临床试验的患者。首席研究员 (PI) 主要负责监督，但额外的安全措施包括综合科学、安全和伦理审查以及监控与质量保证审核相结合。临床研究的主要监督在 DLDCC 进行的与临床试验的启动、监测和终止相关的由 (1) 方案审查和监测委员会 (PRMC)、(2) 数据审查监督委员会（刚果民主共和国）； (3) 一名患者安全官员 (PSO)，确保所有数据监控癌症中心试验是按照批准的监测计划进行的。每个 DLDCC 方案必须有数据和安全监测计划，并由主管部门审查和批准 PRMC 在患者入组之前。可以完成对 DLDCC 协议的协议监控通过多种机制，包括：NCI 合作组数据和安全审查委员会，由制药或学术赞助商 DLDCC 建立的医疗监督员或委员会常设数据审查委员会或个人、特定于方案的数据和安全监测董事会。委员会和 PSO 向临床研究领导委员会报告在 DLDCC 内，并最终向癌症中心主任报告。