内部科学同行评审委员会

Doctors discussing a presentation in hospital conference room

The 内部科学同行评审委员会 (ISPRC) reviews clinical oncology protocols conducted by UCLA Health 约翰逊综合癌症中心 investigators. Drs. John Glaspy and Albert Lai serve as Co-Chairmen of the ISPRC. 在他们的指导下, the committee reviews the required elements of the clinical protocol, statistical applications and other factors such as adequate research staffing, 任何竞争性试验, well-constituted data collection forms and utilization of other 癌症中心 resources.

会议及常见问题

会议每两周在星期二举行一次. The deadline for submissions is two weeks prior to each meeting as noted in the ISPRC会议时间表 link above. 

提交

ISPRC提供初步审查, 方案修订审查(包括PI变更), 持续评审和结束评审.

初步审查

The 癌症中心 ISPRC New Study Submission application is submitted via the CAFÉ portal. 只接受电子提交.

议定书修订审查

皇冠hga025大学洛杉矶分校审查委员会批准的研究

Submit a webIRB Amendment application and CORA will be notified of your protocol amendment via an auto notification # 31 as long as the amendment trigger options are selected in the view amendment section of the webIRB amendment submission. See entry # 6 below to view the IRB Amendment Submission selections that trigger ISPRC notification #31 to (电子邮件保护).

经IRB批准的研究

Email the protocol amendment (clean and tracked) and a summary of changes to ISPRC via (电子邮件保护). We then place the protocol amendment under ISPRC review and release correspondence or an approval.

继续复习

每年, study are assessed by the ISPRC on their success with meeting their annual accrual targets provided in the initial ISPRC CAFÉ application. 在最初的应用中, investigators indicate how many patients are targeted at UCLA and the total number of months accrual will be open (aka accrual duration). Studies that are not meeting their annual accrual target and are therefore not on track to meet their overall accrual target may be required to close the study. 

皇冠hga025大学洛杉矶分校IRB批准的研究

Submit a 继续复习 (CR) application to the IRB in webIRB and notification #98 is triggered which alerts CORA that a study requires ISPRC CR approval

皇冠hga025大学洛杉矶分校IRB批准的研究，不需要CR

每年, 基于ISPRC的初始批准日期, these studies land on a report which alerts CORA that a study in this category requires ISPRC CR approval. 无需额外提交.

经IRB批准的研究

每年, 基于ISPRC的初始批准日期, these studies land on a report which alerts CORA that a study in this.

ISPRC豁免

New studies that meet ISPRC exemption requirements are not subject to Full Board Review and are issued an ISPRC exemption letter after submission of the JCCC DSMB/ISPRC New Study CAFÉ application. Note that in order to access the JCCC DSMB/ISPRC New Study CAFÉ application, the study must be submitted to the IRB and have an OnCore record.

Exemption classification is determined by the ISPRC Co-Chairs or their qualified designee, 基于以下标准:

  • Observational research, descriptive research, questionnaires and focus groups;
  • 辅助试验(i).e., pharmacokinetic research, pharmacogenetic research, and long-term follow up protocols);
  • 相关研究:使用组织的研究.e., 从现有的组织库中, 创建组织库, 遗传流行病学, and collection of tissues for lab based trials (such as biomarker research) that pose no more than minimal risk to subjects;
  • 去识别组织的研究;
  • Treatment/management guidelines not asking a research question;
  • Use and collection of de-identified (anonymized) human specimens, 对参与者的风险不超过最小;
    • 回顾性图表审核和数据库审核.

Subject accrual will not be monitored by the 癌症中心 for exempt protocols that fall into the following categories:

  • 仅涉及去识别样本的协议;
  • 回顾图表审查;
  • Tissue banking protocols that do not yet have a study endpoint or purpose.

Once a study has been deemed “exempt” it will not be re-reviewed by the ISPRC. The exemption letter may be provided to the UCLA IRB and the PI follows institutional policies for amendments and renewal.

Should there be an issue or question about the exemption status of a study, the ISPRC Administrative Director or the ISPRC Co-chairs and/or full committee reviews the study and determines the status. 所有豁免决定必须由ISPRC做出.

培训

ISPRC submission training may be requested at any time through the 癌症中心's 临床研究 Unit 培训 unit at (电子邮件保护) (JCCC质量绩效 & 教育).

问题和ISPRC提交支持

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

吉娜Santisaranyu
ISPRC Specialist, Clinical Oncology Research Administration
(310) 853-5845

玛吉Lindenbaum
临床研究支持服务部主任
(424) 440-0438