Protocol Review and Monitoring System (PRMS)
方案审查和监控系统 (PRMS)
基本信息
- 批准号:7438508
- 负责人:
- 金额:$ 3.74万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2007
- 资助国家:美国
- 起止时间:2007-06-04 至 2010-05-31
- 项目状态:已结题
- 来源:
- 关键词:Adverse eventAgreementCancer PatientClinical TrialsClinical Trials Data Monitoring CommitteesComprehensive Cancer CenterDataDisease ManagementDoctor of MedicineDoctor of PhilosophyEnrollmentEnsureFacultyFundingGoalsHornsMalignant NeoplasmsMaster of Business AdministrationMedical ResearchMonitorOperative Surgical ProceduresPersonsProceduresProtocols documentationRecommendationReportingResearch Ethics CommitteesResearch InfrastructureResearch PersonnelResourcesReview CommitteeSafetyStandards of Weights and MeasuresStructureSystemUniversitiesWorkauthoritybasehuman subjectmedical schoolsmemberpatient safety
项目摘要
The goal of the Protocol Review and Monitoring System (PRMS) is to ensure scientific quality and
patient safety. The PRMS provides internal oversight of the scientific, research, and resource aspects of
all cancer clinical trials at the center. Additionally it is responsible for prioritization of trials. At Stanford,
the PRMS consists of two committees: the Scientific Review Committee (SRC) and the Data and Safety
Monitoring Committee (DSMC).
In the spring of 2004, Susan Knox, Ph.D., M.D. was appointed the Faculty Director of the PRMS and
along with Miriam Bischoff, M.S., M.B.A., Facility Director, the PRMS structure, committees, and
standard operating procedures were developed. The PRMS provides the administrative infrastructure
and its Executive Committee provides the directions for the operations of the two committees. Sandra
Horning, M.D., serves as the Chair of the SRC. Robert Carlson, M.D. is the Vice Chair of the SRC. Susan
Knox, Ph.D., M.D. chairs the DSMC. She is assisted by Sandhya Srinivas, M.D. Beginning in September
2004, the PRMS received funding from the School of Medicine to hire 2 FTE's; an Administrative
Director and an Associate. Partial funding for the Director and Committee Chairs was also provided.
The committees, each with its own standard operating procedures (included as an attachment) became
operational in April, 2005.
The 35-person SRC meets twice per month and reviews all trials that have cancer patients enrolled.
All Comprehensive Cancer Center studies are reviewed and prioritized by a disease management group
prior to SRC review. Studies can be submitted simultaneously to the Stanford's Administrative Panels
on Human Subjects in Medical Research, referred to as the Institutional Review Board (IRB). The PRMS
administration works closely with the IRB to assure that all studies are reviewed and approved by both
organizations prior to opening the study to accrual. The SRC monitors study accrual and progress on an
annual basis.
The 18-person DSMC meets once per month to review monitored investigator-initiated studies and
adverse event reports. The DSMC can recommend that a study be closed to the SRC. The SRC has the
authority to close non-performing studies based upon its review or its agreement with the
recommendation of the DSMC.
方案审查和监测系统的目标是确保科学质量,
患者安全。PRMS提供科学,研究和资源方面的内部监督,
所有的癌症临床试验此外,它还负责确定审判的优先次序。在斯坦福大学,
PRMS由两个委员会组成:科学审查委员会(SRC)和数据与安全委员会(DSASS)
监测委员会。
2004年春天,苏珊·诺克斯博士,M.D.被任命为PRMS的学院主任,
沿着的还有米里亚姆·比肖夫,硕士,工商管理硕士设施总监、PRMS结构、委员会和
制定了标准作业程序。PRMS提供管理基础设施
其执行委员会负责指导两个委员会的运作。桑德拉
Horning,医学博士,担任SRC的主席。Robert Carlson,医学博士是SRC的副主席苏珊
诺克斯博士,M.D.主持DSMC。她是由Sandhya Srinivas,医学博士协助。从9月开始
2004年,PRMS从医学院获得资金,聘请2名全职员工;一名行政人员
主任和助理。还为主任和委员会主席提供了部分资金。
各委员会都有自己的标准作业程序(作为附件列入),
2005年4月开始运营。
SRC由35人组成,每月开会两次,审查所有有癌症患者参加的试验。
所有综合癌症中心的研究都由疾病管理小组进行审查和优先排序
在SRC审查之前。研究报告可以同时提交给斯坦福大学的行政小组
医学研究中的人类受试者,称为机构审查委员会(IRB)。的prm
行政部门与IRB密切合作,以确保所有研究都得到双方的审查和批准。
在研究开始之前,组织应进行累积。SRC监测研究累积和进展,
每年的基础上。
由18人组成的DSMC每月举行一次会议,审查受监测的由制药商发起的研究,
不良事件报告。DSMC可以建议SRC关闭研究。SRC拥有
有权根据其审查或与
DSMC的建议。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Susan J. Knox其他文献
Combined-modality therapy using intratumoral fluorouracil gel and radiation potentiates the radiation effect in a murine solid tumor model
- DOI:
10.1016/s0360-3016(98)80326-x - 发表时间:
1998-01-01 - 期刊:
- 影响因子:
- 作者:
Ning Y. Yu;Montesa B. Patawaran;Joy Y. Chen;Rhoneil L. Peña;Shoucheng Ning;Susan J. Knox;Dennis M. Brown;Richard E. Jones - 通讯作者:
Richard E. Jones
Effects of stem cell factor on the growth and radiation survival of tumor cells.
干细胞因子对肿瘤细胞生长和放射存活的影响。
- DOI:
- 发表时间:
1995 - 期刊:
- 影响因子:11.2
- 作者:
Chaoxiang Shui;W. Khan;Bryan R. Leigh;Anne M. Turner;Richard B. Wilder;Susan J. Knox - 通讯作者:
Susan J. Knox
Sodium Selenite Radiosensitizes Hormone-Refractory Prostate Cancer Xenograft Tumors but Not Intestinal Crypt Cells <em>In Vivo</em>
- DOI:
10.1016/j.ijrobp.2010.03.006 - 发表时间:
2010-09-01 - 期刊:
- 影响因子:
- 作者:
Junqiang Tian;Shouchen Ning;Susan J. Knox - 通讯作者:
Susan J. Knox
Radioimmunotherapy of the Non-Hodgkin's Lymphomas.
- DOI:
10.1016/s1053-4296(05)80030-x - 发表时间:
1995-10 - 期刊:
- 影响因子:3.5
- 作者:
Susan J. Knox - 通讯作者:
Susan J. Knox
131I-Tositumomab (Bexxar®) vs.90Y-Ibritumomab (Zevalin®) Therapy of Low-Grade Refractory/Relapsed Non-Hodgkin Lymphoma
- DOI:
10.1007/s11307-009-0245-9 - 发表时间:
2009-06-20 - 期刊:
- 影响因子:2.500
- 作者:
Andrei Iagaru;Erik S. Mittra;Kristen Ganjoo;Susan J. Knox;Michael L. Goris - 通讯作者:
Michael L. Goris
Susan J. Knox的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Susan J. Knox', 18)}}的其他基金
CLINICAL TRIAL: BEXXAR COMBINED WITH EXTERNAL BEAM RADIATION THERAPY FOR PATIENT
临床试验:BEXXAR 结合外照射治疗患者
- 批准号:
7717921 - 财政年份:2007
- 资助金额:
$ 3.74万 - 项目类别:
CLINICAL TRIAL: PHASE II STUDY OF BEXXAR IN RELAPSED/REFRACTORY DLCL
临床试验:BEXXAR 治疗复发/难治性 DLCL 的 II 期研究
- 批准号:
7717876 - 财政年份:2007
- 资助金额:
$ 3.74万 - 项目类别:
PHASE II STUDY OF BEXXAR IN RELAPSED/REFRACTORY DLCL
BEXXAR 治疗复发/难治性 DLCL 的 II 期研究
- 批准号:
7605217 - 财政年份:2007
- 资助金额:
$ 3.74万 - 项目类别:
PHASE II STUDY OF BEXXAR IN RELAPSED/REFRACTORY DLCL
BEXXAR 治疗复发/难治性 DLCL 的 II 期研究
- 批准号:
7375291 - 财政年份:2005
- 资助金额:
$ 3.74万 - 项目类别:
IODINE ANTI B1 MURINE RADIOIMMUNOTHERAPY FOR CHEMOTHERAPY LYMPHOMA
碘抗 B1 鼠放射免疫治疗化疗淋巴瘤
- 批准号:
6264317 - 财政年份:1998
- 资助金额:
$ 3.74万 - 项目类别:
PIVOTAL PHASE II/III OF MURINE RADIOIMMUNOTHERAPY FOR LYMPHOMAS
鼠淋巴瘤放射免疫治疗的关键 II/III 期
- 批准号:
6115083 - 财政年份:1998
- 资助金额:
$ 3.74万 - 项目类别:
ANTI-B1 (MURINE) IN CHEMOTHERAPY-REFRACTORY LOW GRADE NONHODGKIN'S LYMPHOMA
化疗难治性低度非霍奇金淋巴瘤中的抗 B1(鼠)抗体
- 批准号:
6115044 - 财政年份:1998
- 资助金额:
$ 3.74万 - 项目类别:
PHASE II MULTICENTER TRIAL OF 90 YTTRIUM DOTA BIOTIN IN SUBJECTS W/ CANCER
90 钇 DOTA 生物素在癌症受试者中的 II 期多中心试验
- 批准号:
6264323 - 财政年份:1998
- 资助金额:
$ 3.74万 - 项目类别:
ANTI-B1 (MURINE) IN CHEMOTHERAPY-REFRACTORY LOW GRADE NONHODGKIN'S LYMPHOMA
化疗难治性低度非霍奇金淋巴瘤中的抗 B1(鼠)抗体
- 批准号:
6219353 - 财政年份:1998
- 资助金额:
$ 3.74万 - 项目类别:
相似海外基金
A study for cross borders Indonesian nurses and care workers: Case of Japan-Indonesia Economic Partnership Agreement
针对跨境印度尼西亚护士和护理人员的研究:日本-印度尼西亚经济伙伴关系协定的案例
- 批准号:
22KJ0334 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Grant-in-Aid for JSPS Fellows
NSF-NOAA Interagency Agreement (IAA) for the Global Oscillations Network Group (GONG)
NSF-NOAA 全球振荡网络组 (GONG) 机构间协议 (IAA)
- 批准号:
2410236 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Cooperative Agreement
Conditions for U.S. Agreement on the Closure of Contested Overseas Bases: Relations of Threat, Alliance and Base Alternatives
美国关于关闭有争议的海外基地协议的条件:威胁、联盟和基地替代方案的关系
- 批准号:
23K18762 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Grant-in-Aid for Research Activity Start-up
MSI Smart Manufacturing Data Hub – Open Calls Grant Funding Agreement
MSI 智能制造数据中心 – 公开征集赠款资助协议
- 批准号:
900240 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Collaborative R&D
Challenges of the Paris Agreement Exposed by the Energy Shift by External Factors: The Case of Renewable Energy Policies in Japan, the U.S., and the EU
外部因素导致的能源转移对《巴黎协定》的挑战:以日本、美国和欧盟的可再生能源政策为例
- 批准号:
23H00770 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Grant-in-Aid for Scientific Research (B)
Continuation of Cooperative Agreement between U.S. Food and Drug Administration and S.C. Department of Health and Environmental Control (DHEC) for MFRPS Maintenance.
美国食品和药物管理局与南卡罗来纳州健康与环境控制部 (DHEC) 继续签订 MFRPS 维护合作协议。
- 批准号:
10829529 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
National Ecological Observatory Network Governing Cooperative Agreement
国家生态观测站网络治理合作协议
- 批准号:
2346114 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Cooperative Agreement
The Kansas Department of Agriculture's Flexible Funding Model Cooperative Agreement for MFRPS Maintenance, FPTF, and Special Project.
堪萨斯州农业部针对 MFRPS 维护、FPTF 和特别项目的灵活资助模式合作协议。
- 批准号:
10828588 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Robust approaches for the analysis of agreement between clinical measurements: development of guidance and software tools for researchers
分析临床测量之间一致性的稳健方法:为研究人员开发指南和软件工具
- 批准号:
MR/X029301/1 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Research Grant
Doctoral Dissertation Research: Linguistic transfer in a contact variety of Spanish: Gender agreement production and attitudes
博士论文研究:西班牙语接触变体中的语言迁移:性别协议的产生和态度
- 批准号:
2234506 - 财政年份:2023
- 资助金额:
$ 3.74万 - 项目类别:
Standard Grant