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:
- 金额:$ 4.21万
- 依托单位:
- 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:
- 关键词:AddressAdherenceAdultAdverse eventAffectAmbulatory CareAmendmentAmerican College of Surgeons Oncology GroupAreaAttentionBehavioralBehavioral ResearchBiologyBlindedCancer CenterCancer Trials Support UnitCategoriesCellsChildhoodClinical ResearchClinical Research AssociateClinical TrialsClinical Trials Data Monitoring CommitteesCommittee MembersConduct Clinical TrialsConfidentialityConflict (Psychology)Conflict of InterestConstitutionCoupledDataData CollectionData QualityDatabasesDevelopmentDiagnostic and Statistical ManualDisclosureDoseDrug IndustryElectronicsEligibility DeterminationEmployeeEnrollmentEnsureEnvironmentEpidemiologyEthical ReviewEvaluationEventFDA approvedFacultyFrequenciesFundingFutureGenetic MaterialsGood Clinical PracticeGrantGuidelinesHospitalsImageIndividualInstitutionInternationalInterventionLate EffectsLeadLeadershipMaintenanceMalignant NeoplasmsManuscriptsMasksMeasuresMedicalMedicineMissionModificationMonitorNCI-Designated Cancer CenterNational Surgical Adjuvant Breast and Bowel ProjectNotificationNursing ResearchNutritionalOutcomeOutcome MeasureParticipantPatientsPeer ReviewPersonsPharmacologic SubstancePhasePhase I Clinical TrialsPlacebo ControlPoliciesPreparationPrincipal InvestigatorProceduresProcessProtocol ComplianceProtocols documentationPublished CommentQuality ControlQuality of lifeRandomizedRecommendationRegulationReportingResearchResearch DesignResearch Ethics CommitteesResearch InfrastructureResearch PersonnelResourcesRestReview CommitteeRiskRoleSafetyScheduleSourceSouthwest Oncology GroupStandardizationStructureSuspension substanceSuspensionsTeleconferencesTherapeuticTimeToxic effectTrainingVotingWritingarmbasecancer preventioncancer research center directorcollegecomputerized data processingdata formatdesigngene therapyhigh riskimprovedmeetingsmemberpatient safetyprimary outcomeprogramsquality assuranceresearch studyresponserisk benefit ratiosymposium
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)的最高优先级是确保安全的,
参与临床试验的患者。主要研究者(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,
监测与质量保证审计相结合。临床研究的主要监督
在DLDCC进行的与临床试验启动、监查和终止相关的研究
由(1)方案审查和监测委员会(PRMC)监督,(2)数据审查
委员会(DRC);(3)患者安全官(PSO),确保所有数据监测
癌症中心试验按照批准的监测计划进行。每个DLDCC
研究方案必须有数据和安全性监测计划,并由
患者入组前的PRMC。可以完成对DLDCC协议的协议监视
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建立的医学监查员或委员会
常设数据审查委员会或个人、方案特定数据和安全性监查
板.委员会和PSO向临床研究领导委员会报告
在DLDCC内部,并最终向癌症中心主任报告。
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 M. BLANEY其他文献
SUSAN M. BLANEY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 M. BLANEY', 18)}}的其他基金
CLINICAL TRIAL: A PHASE I TRIAL OF CAPECITABINE RAPIDLY DISINTEGRATING TABLETS
临床试验:卡培他滨快速崩解片的 I 期试验
- 批准号:
8356676 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
CLINICAL TRIAL: A PHASE I STUDY OF MK-0752 IN PEDIATRIC PATIENTS WITH RECURREN
临床试验:MK-0752 在复发性儿科患者中的 I 期研究
- 批准号:
8356709 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
CLINICAL TRIAL: PBTC-019: A PHASE I PHARMACOKINETIC OPTIMAL DOSING STUDY OF INT
临床试验:PBTC-019:INT 的 I 期药代动力学最佳剂量研究
- 批准号:
8356671 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
CLINICAL TRIAL: A PHASE I TRIAL OF ESCALATING DOSES OF KARENITECIN PLUS CYCLOPH
临床试验:Karenitecin 加 CYCLOPH 剂量递增的 I 期试验
- 批准号:
8356684 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
PBTC-025-A PHASE I PHARMACOPKINETIC AND SAFETY STUDY IN CHILDREN
PBTC-025-A 儿童 I 期药代动力学和安全性研究
- 批准号:
8356726 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
A PHASE I STUDY OF ABT-888, AN ORAL INHIBITOR OF POLY
ABT-888(一种口服 POLY 抑制剂)的 I 期研究
- 批准号:
8356743 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
CLINICAL TRIAL: PBTC-022 PHASE II STUDY OF BEVACIZUMAB PLUS IRINOTECAN (CAMPTOS
临床试验:贝伐珠单抗加伊立替康 (CAMPTOS) 的 PBTC-022 II 期研究
- 批准号:
8356679 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
NANT 2007-02 - A PHASE I STUDY OF BEVACIZUMAB WITH BOLUS
NANT 2007-02 - 贝伐珠单抗推注的 I 期研究
- 批准号:
8356742 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
CLINICAL TRIAL: A PHASE II TRIAL OF CAPECITABINE RAPIDLY DISINTEGRATING TABLETS
临床试验:卡培他滨快速崩解片的 II 期试验
- 批准号:
8356747 - 财政年份:2010
- 资助金额:
$ 4.21万 - 项目类别:
相似海外基金
Structural Racism, Pharmacy Closures and Disparities in Medication Adherence Among Older Adult Medicare Part-D Beneficiaries
结构性种族主义、药房关闭以及老年人医疗保险 D 部分受益人的药物依从性差异
- 批准号:
10568717 - 财政年份:2023
- 资助金额:
$ 4.21万 - 项目类别:
Medication Adherence and Cardio-Metabolic Control Indicators among Adult American Indians Receiving Tribal Health Services
接受部落卫生服务的成年美洲印第安人的药物依从性和心脏代谢控制指标
- 批准号:
10419967 - 财政年份:2022
- 资助金额:
$ 4.21万 - 项目类别:
Medication Adherence and Cardio-Metabolic Control Indicators among Adult American Indians Receiving Tribal Health Services
接受部落卫生服务的成年美洲印第安人的药物依从性和心脏代谢控制指标
- 批准号:
10592441 - 财政年份:2022
- 资助金额:
$ 4.21万 - 项目类别:
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients
利用技术提高青少年和年轻肾移植或肝移植受者的药物依从性
- 批准号:
10369750 - 财政年份:2021
- 资助金额:
$ 4.21万 - 项目类别:
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients
利用技术提高青少年和年轻肾移植或肝移植受者的药物依从性
- 批准号:
10633248 - 财政年份:2021
- 资助金额:
$ 4.21万 - 项目类别:
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients
利用技术提高青少年和年轻肾移植或肝移植受者的药物依从性
- 批准号:
10487516 - 财政年份:2021
- 资助金额:
$ 4.21万 - 项目类别:
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
Mhealth 促进年轻 MSM 遵守暴露前预防
- 批准号:
10228564 - 财政年份:2018
- 资助金额:
$ 4.21万 - 项目类别:
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
Mhealth 促进年轻 MSM 遵守暴露前预防
- 批准号:
9347041 - 财政年份:2017
- 资助金额:
$ 4.21万 - 项目类别:
Mindfulness training with HIV-positive youth and adult family members to improve treatment adherence
对艾滋病毒呈阳性的青少年和成年家庭成员进行正念训练,以提高治疗依从性
- 批准号:
9480702 - 财政年份:2016
- 资助金额:
$ 4.21万 - 项目类别:
Mindfulness training with HIV-positive youth and adult family members to improve treatment adherence
对艾滋病毒呈阳性的青少年和成年家庭成员进行正念训练,以提高治疗依从性
- 批准号:
9906853 - 财政年份:2016
- 资助金额:
$ 4.21万 - 项目类别: