Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 11
- 主要终点
- Test the frequency(%) of sites that successfully submitted implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.
研究概览
简要总结
An initial step toward more accurate and complete data acquisition for clinical trials, the Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Pediatric Brain Tumor Consortium (PBTC) will assess the feasibility of electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE that is housed within each consortium's Uniform Resource Locator (URL). This study will assess efficiency, effectiveness, and scalability of the laboratory data extraction and transfer processes. This study will identify factors in the process that impact consortium operations, central protocol activation and implementation to the point of declaring the site data-ready.
详细描述
PRIMARY OBJECITVES
I. To test the feasibility of implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.
SECONDARY OBJECTIVES
I. To identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Data Inclusion Criteria: Specific patient clinical research data to be included in this study for retrospective data capture and analysis will originate from the following PEP-CTN and PBTC studies:
- •PEP-CTN: ADVL1412, ADVL1312, ADVL1411
- •PBTC: PBTC-042, PBTC-047 (Stratum 1), PBTC-050, PBTC-051 (Stratum 1)
- •Participating Site Inclusion Criteria: Data from above clinical studies at the following institutions will be included in the initial pilot, with potential to expand to other sites at which patients on these studies were treated.
- •Site Participation: Children's Healthcare of Atlanta - Scottish Rite and Egleston, Children's Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center, Seattle Children's Hospital, St. Jude Children's Research Hospital, Texas Children's Hospital, and University of California, San Francisco - Mission Bay
排除标准
- 未提供
研究组 & 干预措施
Laboratory Data
Electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE
干预措施: Medidata RAVE (Other)
结局指标
主要结局
Test the frequency(%) of sites that successfully submitted implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.
时间窗: 18 months
Thorough evaluation of the data extraction and transfer process from each participating site to the PBTC and PEP-CTN databases. Establish feasibility of the proposed process at each site as well as the operations cores.
次要结局
- Identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.(18 months)