数据安全监控委员会

The UCLA Health 约翰逊综合癌症中心 Data Safety and Monitoring Board (JCCC DSMB) was constituted in January 2001 and provides data and safety monitoring services for 癌症中心 interventional, 没有外部DSMB的UCLA机构研究. 癌症中心 oversight includes review of studies prior to initiation to ensure appropriate safety data reporting and statistical analysis plans and safety measures are in place prior to approval. The 癌症中心 further verifies the institutional trials have appropriately reported safety and data outcomes, as well as are compliant with state and federal regulations throughout the execution of the clinical trial. The JCCC DSMB also reviews all Serious Adverse Events (SAEs) occurring on studies with DSMB oversight. JCCC DSMB的主席是Dr. 斯文·德·沃斯.

The compliance team from the Office of Regulatory Compliance (ORC) executes compliance oversight on behalf of the DSMB. The ORC is a team of qualified and trained Compliance Officers and administrators whom monitor, 审核和审查机构试验的患者资格. 经DSMB批准并在数据中列出的风险评分 & Safety Monitoring Plan regulates the frequency and amount the trials are monitored and audited.

除合规官员负责监督外, 利用JCCC DSMB对机构试验进行监测和审计, the ORC may also audit any cancer-related clinical trial conducted at UCLA regardless of sponsor type to ensure 癌症中心 oversight of compliance and data integrity of all other trials conducted at UCLA.

会议及常见问题

• DSMB会议时间表
• DSMB一般指导文件
• DSMB FAQ

DSMB meetings are held on the first Tuesday of every month except when the meeting day is after a holiday, 在这种情况下，会议在每月的第二个星期二举行. The deadline for submissions is two weeks prior to each meeting as noted in the DSMB会议时间表 link above. 

提交

• DSMB提交摘要1页

初步审查

• Instructions for Electronic New Study 提交 using CAFÉ (Comprehensive Ancillary Forms Engine)
• JCCC协议审查流程指南(DSG-DSMB-ISPRC协议审查流程)

The 癌症中心 utilizes a single New Study Submission application for both ISPRC review and DSMB oversight requests. The 癌症中心 ISPRC/DSMB New Study Submission application is submitted via the CAFÉ portal. When JCCC DSMB oversight is requested, additional DSMB related questions appear in the application. 只有在DSMB批准研究后，ISPRC审查才会自动启动. 只接受电子提交.

总结报告

• JCCC DSMB汇总报告模板(所有风险级别)

Summary reports provide the DSMB with a summary of pertinent data related to the progress of the study including accrual, 安全更新, 协议的修改, 偏差, 不良事件和一般更新. 上面的模板涵盖了摘要报告的所有必需元素. 每季度必须提交总结报告, 根据DSMB指定的风险级别，每半年或每年进行一次. The study's initial approval notice confirms the assigned Risk Level and frequency of 总结报告 and monitoring.

严重不良事件(SAE)报告

• JCCC DSMB严重不良事件报告指南

SAEs must be submitted to the DSMB via OnCore within 10-days of awareness and 2-days of awareness if a death, regardless of attribution (related or not-related) to study intervention or study participation. 参见上面的OnCore提交步骤指南.

单一主题例外请求

• 单一主题例外申请表格

By policy, single subject exceptions to study eligibility are not approved by the JCCC DSMB.

研究者发起的多地点研究的参与地点

• JCCC DSMB参与站点多站点协议协议

Participating sites on an Investigator initiated multi-site study require approval by the DSMB prior to activation of the participating site. 对参与的场地进行检讨, 下载并完成每个站点的JCCC多站点协议. The agreement includes a description of the requirements and documents that you should be submitted to the JCCC DSMB.

稿件或摘要评论

Draft manuscripts (and abstracts or other publications that include data from the study) require DSMB review. Investigators can submit manuscripts (and abstracts or other publications that include data from the study) in parallel with the submission to the journal or conference. 这两个提交不必按顺序进行.

JCCC数据和安全监控计划(DSMP)和协议模板

• JCCC DSMP
• JCCC介入协议模板

如果研究者没有使用JCCC介入方案模板, and still needs to incorporate the JCCC DSMB requirements in the study protocol, 调查人员通常是这样做的. 查看与AE报告和文档相关的部分,“数据安全监控。,” and “Monitoring” insert language from the JCCC Protocol Template (see below) into the study specific protocol, and file a copy of the JCCC Data Safety Monitoring Plan (DSMP) along with the protocol in the TMF and ISF. 您可以选择将DSMP附加到协议中，但这不是必需的.

• JCCC DSMB协议模板(介入性)
  • 不良经历报告和文件(第11节，第19-24页)
  • 数据安全监察(第14条，第26页)
  • 监察(第16条).6, pg 28)

All other sections of the DSMB Protocol Template are provided as a guide and can be used when appropriate for the study. 如果某一特定部分与研究无关, 调查员可以选择输入“不适用”并说明理由, 为了证明这部分至少被考虑过, 而不是完全省略这一部分. 最终, the JCCC DSMB is not looking for exact use of the JCCC DSMB Protocol Template, but it will review the language in the study specific protocol for alignment with the JCCC DSMP and sound design of the study and statistical analysis plan.

If your study protocol requires more specific guidance, please send your inquiry to (电子邮件保护) or (电子邮件保护) 一个团队成员会与你建立联系.

Training

DSMB Orientation for Investigators and Staff is required training for all new studies under JCCC DSMB oversight. The DSMB Initial Approval Letter instructs study teams to contact their assigned compliance officer to schedule this required training. DSMB orientation training for new team members after study initiation may be requested at any time through the JCCC 临床研究 Unit Training unit at (电子邮件保护) (JCCC质量绩效 & 教育).

问题和DSMB提交支持

癌症中心的 临床肿瘤研究管理局 团队支持JCCC DSMB的管理活动. 任何提交问题，请直接发送至 (电子邮件保护).

Jorge Huezo
临床肿瘤研究管理局DSMB专家
(310) 730-8509

玛吉Lindenbaum
Director, Clinical Oncology Research Administration and Office of Regulatory Compliance
(424) 440-0438