Core--Clinical

核心--临床

基本信息

批准号：
7631320
负责人：
JOSEPH Wayne FAY
金额：
$ 13.52万
依托单位：
BAYLOR RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2000
资助国家：
美国
起止时间：
2000-09-30 至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7631320
关键词：
Academic Medical Centers Accreditation Adherence Adverse event Amendment Area Autologous Blood Blood Component Removal Bone Marrow Transplantation Books CD34 gene Case Report Form Cell Therapy Cells Clinical Clinical Data Clinical Protocols Clinical Research Clinical Research Protocols Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Design Code Collaborations Collection Color Confidentiality Consent Forms Data Data Collection Dendritic Cell Vaccine Dendritic Cells Documentation Effectiveness Enrollment Ensure Foundations Guanosine Monophosphate Guidelines Health Insurance Portability and Accountability Act Hematopoietic stem cells Human Human Subject Research Immunology Immunotherapy Individual Informed Consent Institutes Laboratories Laboratory Research Laboratory Study Metastatic Melanoma Mission Monitor Monitoring Clinical Trials Mononuclear National Cancer Institute Nursing Staff Operative Surgical Procedures Outcomes Research Patient Participation Patients Performance Personal Computers Pharmaceutical Preparations Policies Principal Investigator Procedures Protocols documentation Records Reporting Research Research Ethics Committees Research Institute Research Personnel Safety Secure Standards of Weights and Measures Time United States Update Vaccine Design Vaccines Writing healthy volunteer human subject improved melanoma monocyte novel strategies patient safety progenitor programs research study response volunteer

Academic Medical Centers Accreditation Adherence Adverse event Amendment Area Autologous Blood Blood Component Removal Bone Marrow Transplantation Books CD34 gene Case Report Form Cell Therapy Cells Clinical Clinical Data Clinical Protocols Clinical Research Clinical Research Protocols Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Design Code Collaborations Collection Color Confidentiality Consent Forms Data Data Collection Dendritic Cell Vaccine Dendritic Cells Documentation Effectiveness Enrollment Ensure Foundations Guanosine Monophosphate Guidelines Health Insurance Portability and Accountability Act Hematopoietic stem cells Human Human Subject Research Immunology Immunotherapy Individual Informed Consent Institutes Laboratories Laboratory Research Laboratory Study Metastatic Melanoma Mission Monitor Monitoring Clinical Trials Mononuclear National Cancer Institute Nursing Staff Operative Surgical Procedures Outcomes Research Patient Participation Patients Performance Personal Computers Pharmaceutical Preparations Policies Principal Investigator Procedures Protocols documentation Records Reporting Research Research Ethics Committees Research Institute Research Personnel Safety Secure Standards of Weights and Measures Time United States Update Vaccine Design Vaccines Writing healthy volunteer human subject improved melanoma monocyte novel strategies patient safety progenitor programs research study response volunteer

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项目摘要

The clinical core has the responsibility of implementation and close monitoring of the clinical trials investigating the effectiveness of dendritic cell (DC) immunotherapy for metastatic melanoma as outlined in the specific aims of investigators at the Baylor Institute for Immunology Research. The functions of the Clinical Core are divided into four general areas: (1) Performance of clinical trials involving patients with metastatic melanoma with the highest level of good clinical practice; (2) Implementation of clinical research after approval by the Institutional Review Board (IRB) of the Baylor University Medical Center (BUMC), the National Cancer Institute (NCI) and the United States Federal Drug Administration (FDA); (3) Write, implement and update as necessary a clinical trial monitoring policy as mandated by the Baylor Research Institute (BRI) in Dallas and the FDA in collaboration with our outside clinical protocol monitors to promote accurate collection of clinical and laboratory research data, prompt and comprehensive reporting of adverse events as a result of patient participation in clinical research to the IRB,NCI and FDA and to ensure patient safety; (4) Operate and oversee the apheresis center at BUMC to ensure patient safety and proper collection of autologous mononuclear cells for DC vaccine design; (5) Maintain high quality records of patient participation and document regulatory activities of the clinical research in collaboration with the DC Core in a manner acceptable to the IRB,NCI and FDA. The core will be responsible for the integrity of the clinical outcomes of the research. We have established a Data Safety and Monitoring Board (DSMB) and a Melanoma Trials Overview Committee (MTOC) as oversight entities.

临床核心负责对调查的临床试验进行实施和密切监测树突状细胞（DC）免疫疗法对转移性黑色素瘤的有效性，如特定目的贝勒免疫学研究所的研究人员。临床核心的功能分为四个一般领域：（1）涉及转移性黑色素瘤患者的临床试验的性能最高良好的临床实践；（2）在机构审查委员会（IRB）批准后实施临床研究贝勒大学医学中心（BUMC），国家癌症研究所（NCI）和美国联邦药物管理（FDA）；（3）根据需要编写，实施和更新一项临床试验监测政策达拉斯的贝勒研究所（BRI）和FDA与我们的外部临床协议监视器合作促进准确收集临床和实验室研究数据，迅速和全面报告不利由于患者参与了IRB，NCI和FDA的临床研究，并确保患者安全；（4）在BUMC上操作和监督刻度中心，以确保患者的安全和适当的自体收集直流疫苗设计的单核细胞；（5）保持患者参与和文件的高质量记录临床研究的监管活动与DC核心以IRB可接受的方式合作和FDA。核心将负责研究的临床结果的完整性。我们已经建立了数据安全和监测委员会（DSMB）和黑色素瘤试验概述委员会（MTOC）作为监督实体。