ADMINISTRATIVE AND CLINICAL RESEARCH

管理和临床研究

• 批准号: 8217346
• 负责人: HELEN E HESLOP
• 金额: $ 24.33万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8217346
• 关键词: Accreditation; Administrative Personnel; Administrator; Advisory Committees; American; Annual Reports; Appointment; Area; Award; Biology; Biometry; Biostatistics Core; Blood; Bone Marrow Transplantation; Budgets; Cancer Center; Cancer Vaccines; Cell Therapy; Clinical; Clinical Research; Clinical Trials; Collaborations; Committee Membership; Communication; Conduct Clinical Trials; Consultations; Correlative Study; Data; Data Analyses; Data Collection; Development; Development Plans; Enrollment; Ensure; Evaluation; Faculty; Foundations; Funding; Genes; Goals; Good Clinical Practice; Grant; Group Meetings; Human Resources; Imaging Techniques; Immune; Immunotherapy; Institutional Review Boards; International; Laboratories; Leadership; Malignant Neoplasms; Manuscripts; Measurement; Medicine; Mentors; Methodology; Molecular; Monitor; National Center for Research Resources; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; Participant; Patients; Peer Review; Physicians; Principal Investigator; Procedures; Program Research Project Grants; Progress Reports; Protocols documentation; Publishing; Quality Control; Recombinant DNA; Recovery; Regulatory Affairs; Relapse; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Research Support; Review Committee; Running; Safety; Schedule; Scientist; Services; Societies; Source; Specialized Center; Statistical Data Interpretation; Stem cell transplant; System; T-Lymphocyte; Therapeutic Studies; Time; Toxic effect; Training; Translational Research; Transplantation; Tumor Immunity; United States National Institutes of Health; Universities; Validation; Visit; adult stem cell; college; data management; experience; gene therapy; improved; lectures; leukemia/lymphoma; meetings; member; neoplastic cell; pre-clinical; programs; protocol development; quality assurance; reconstitution; research study; sound; vector

The goals of the core are to provide all projects with centralized leadership, administrative, biostatistical and clinical research support. The Adminstrative component will be responsible for integrating all components of the PPG and overseeing progress, so that the research objectives are being met. To achieve these goals the core will arrange internal group meetings including the monthly investigator meeting, executive committee meetings and invited research lectures. It will provide assistance to each project and core leader with budgetary issues and will also oversee the overall fiscal and budgetary management of the program. This core will also co-ordinate oversight of the PPG by convening meetings of the Internal and External Advisory Boards and implementing their recomendations. The goals of the clinical research component of this core are to provide all projects with centralized clinical trial support and provide an infrastructure of personnel and services that will adequately support such research. Core services will be provided in regulatory affairs, study coordination, quality assurance and control and data safety monitoring. The Regulatory Affairs component collaborates with investigators to develop and submit all required regulatory documents, including submissions to the IRB, IBC, FDA, and NIH/ORDA and annual reports. This core has extensive experience with IND submission and currently supports over 25 IND studies. The Quality Control (QC) program will ensure that standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are accurately defined and being followed. The QA program will undertake audits after the first patient is enrolled on a study and then randomly to ensure that the studies are being conducted according to Good Clinical Practices. The core will also co-ordinate data monitoring by the Data Review Committee which is responsible for reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies in this program. The Biostatistics component will provide comprehensive and centralized support that integrates the biostatistical activities of the research projects in this PPG. It will coordinate and manage the statistical activities of the program to ensure that investigators have ready access to biostatistical consultation; provide biostatistical expertise in study planning and conduct of clinical trials and preclinical validation experiments, coordinate data management activities and provide comprehensive support for data analysis including safety/toxicity monitoring, interim reviews of data, final analysis, and reporting. The Biostatistics Core personnel will incorporate sound experimental principles in study planning and development, implement a coordinated data management system, and facilitate provision of timely and high-quality statistical analysis and data interpretation.

核心的目标是为所有项目提供集中的领导、行政、生物统计和 临床研究支持。行政部门将负责整合 PPG和监督进展，以便实现研究目标。为了实现这些目标， 核心将安排内部小组会议，包括每月的研究者会议、执行委员会会议 会议和应邀的研究讲座。它将为每个项目和核心领导人提供援助， 预算问题，并将监督该计划的总体财政和预算管理。这 核心小组还将通过召开内部和外部咨询委员会会议，协调对PPG的监督 董事会和执行他们的建议。该核心的临床研究部分的目标 为所有项目提供集中的临床试验支持，并提供人员基础设施， 这些服务将充分支持此类研究。将在法规事务方面提供核心服务， 研究协调、质量保证和控制以及数据安全监测。法规事务 组件与研究者合作，制定并提交所有必要的监管文件， 包括向IRB、IBC、FDA和NIH/RDA提交的资料和年度报告。这一核心具有广泛的 拥有IND提交经验，目前支持超过25项IND研究。质量控制（QC） 该计划将确保方案制定、临床试验开展 准确定义并遵循临床试验的数据收集和管理。质量保证 项目将在首例患者入组研究后进行稽查，然后随机进行稽查，以确保 这些研究是根据药物临床试验质量管理规范进行的。核心还将协调数据 数据审查委员会负责审查和评价毒性和任何 本项目中临床研究的其他研究相关安全性相关数据。生物统计 该构成部分将提供全面和集中的支持， 这个PPG的研究项目。它将协调和管理该方案的统计活动， 确保研究者能够随时获得生物统计咨询;提供生物统计专业知识， 临床试验和临床前验证实验的研究规划和实施，协调数据 管理活动，并为数据分析（包括安全性/毒性）提供全面支持 监测、数据的中期审查、最终分析和报告。生物统计学核心人员将 在研究规划和开发中纳入合理的实验原则， 管理系统，并促进及时提供高质量的统计分析和数据 解释。