激活一项研究
Activation of a new study within the UCLA Health 约翰逊综合癌症中心 requires study approval steps within the 癌症中心 and Enterprise-wide. The guidance below provides insight into activation of 癌症 related interventional and non-interventional studies. Non-interventional studies include but are not limited to observational, 辅助/相关, 回顾图表, 以及标本收集研究.
Cancer-Relevance
如果一项研究符合以下任何一项，就与癌症有关:
- Studies sponsored by the NCI either directly or indirectly; OR
- 研究的目的是治疗, 防止, diagnose 癌症 or improve comfort/quality of life of 癌症 patients.包括流行病学/观察性/辅助相关性(e).g., Lab-based) studies that assess 癌症 risk, outcomes or therapy response; OR
- Studies with a focus on 癌症; OR
- Studies with a subject population primarily made up of 癌症 patients
- Studies where theprotocol describe capturing a 癌症 diagnosis as a data point
- 纳入标准包括癌症诊断的研究
- 协议目标或目的以癌症为重点的研究
如果一项研究是上述任何一种类型, then the 癌症中心 would consider this study 癌症 relevant and the study should be marked as a 癌症 study in the UCLA IRB's new study application and submit a JCCC New Study Application in CAFÉ.
要和某人谈论你的具体研究，发电子邮件 (电子邮件保护) and someone from the 癌症中心's Clinical Oncology Research Administration team will contact you.
新的研究入学表格启动DSG审查
Study activation within the 癌症中心 starts with Disease Site Group (DSG) review. To initiate a DSG review, ensure you have access to the protocol and submit a DSG审查入学表.
Only after approval by one of the 癌症中心's 15 疾病部位分组, is the study eligible to submit a JCCC DSMB/ISPRC application in the CAFÉ portal.
JCCC DSG新研究审查入学表: 点击这里
在CAFÉ上提出新的研究申请以启动DSMB/ISPRC审查
JCCC新研究申请通过CAFÉ门户网站提交. A 提示单 to help you access and use the CAFÉ application is available here: Instructions for Electronic New Study Submissions using CAFÉ (Comprehensive Ancillary Forms Engine)
重要提示:
- The CAFÉ application can only be accessed from within the MEDNET network or via VPN.
- 使用AD凭据登录到CAFÉ应用程序.
- A study must have an OnCore record before a CAFÉ application can be opened. 如果您对OnCore学习记录有任何疑问，请发送电子邮件 (电子邮件保护).
如果您无法访问CAFÉ应用程序, 与临床肿瘤研究管理局(CORA)联系 (电子邮件保护). 我们是来帮忙的.
介入临床研究
Interventional Research are studies where participants are assigned prospectively by an investigator based on a protocol to receive specific interventions. The participants may receive diagnostic, treatment, behavioral, or other types of interventions. 干预的分配可能是随机的，也可能不是随机的. The participants are followed and biomedical and/or health outcomes are assessed.
A study is interventional if the study is designed to alter treatment or intervention decisions, 诊断的方法或作为干预的行为.
JCCC DSG新研究审查入学表: 点击这里
JCCC DSMB/ISPRC新研究项目申请: 点击这里
介入临床研究的详细工作流程:
This schema above is provided to help visualize where the DSG review process might best fit into the 癌症中心's DSMB, ISPRC和企业范围的研究激活过程. 所有激活步骤都不包括在此可视化视图中.
对于研究者发起的研究:
- The DSG has the ability to issue provisional approval with conditions for full approval in cases where a concept is accepted but the study requires revisions to the protocol, statistical analysis plan or some critical element related to study design or feasibility.
非介入性临床研究
所有非介入性临床研究, 下面描述的例子, 需要初始ISPRC评估, and therefore require the submission of a JCCC New Study DSMB/ISPRC CAFÉ application. In order to open a CAFÉ application, you must first submit the study at the IRB. 请参阅下面的重要注意事项和本提示表.
提交JCCC新研究DSMB/ISPRC caf
重要提示:
- The IRB application can be submitted without an ISPRC exemption or approval notice uploaded.
- 如果在IRB应用程序中选择“Yes”为“Cancer Related”, then 24-48 hours after you submit the study's IRB New Study application, 研究应该有一个OnCore记录自动创建.
- An OnCore record for a specific study is required in order to open a JCCC New Study DSMB/ISPRC application in the CAFÉ portal for that study.
- 要排除CAFÉ门户访问问题，请参见此 提示单.
非介入性临床研究(观察性)
Observational Research includes studies that focus on 癌症 patients and healthy populations and involve no prospective intervention or alteration in the status of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. 研究的参与者可能会接受诊断, 治疗, 或者其他干预措施, but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study.
JCCC DSMB/ISPRC新研究项目申请: 点击这里
非介入性临床研究 (Ancillary/Correlative Study)
辅助临床研究是由, 但不是必需的一部分, 主要的临床试验/研究, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study.
Correlative: Laboratory-based studies using specimens to assess 癌症 risk, 临床结果, 对治疗的反应, 等.
JCCC DSMB/ISPRC新研究项目申请: 点击这里
非介入性临床研究 (Retrospective Chart Review)
Retrospective Chart review studies are those studies that collect all study data from a review of existing records.
JCCC DSMB/ISPRC新研究项目申请: 点击这里
有关这些术语如何定义的更多信息，请参阅此处: 癌症centers.癌症.gov / GrantsFunding / DataGuide