目标源数据核查

超过 50%的研究中心监查预算被耗费在源数据核查(SDV)上。然而,逐项核查每一个数据字段对最终试验结果几无影响。

Medidata TSDV(目标源数据核查)助您将核查重心聚焦于 Rave中的关键安全性和有效性数据,在确保监管合规信心的同时,大幅减少不必要的资源投入。

下载概述
Video transcript: One hundred percent source data verification is not sustainable and it's not being recommended by our regulatory agencies. It is widely known that site monitoring costs make up a significant percentage of the clinical trial budget, of which more than half is spent on source data verification. Site monitors typically spend one day per month visiting every site in a study and nearly half of their time on-site doing SDV. EDC systems remain the primary source of the data to be reviewed, but research is also suggesting that while conducting one hundred percent SDV of this data, less than three percent of all case report form data is changed due to post data capture monitoring and dating cleaning. Imagine if instead of spending half of an on-site visit doing SDV, the CRA was able to shift their focus to higher value activities that ensure patient safety, improve data quality, and add to the success of your trial. TSDV allows you to align your SDV efforts to your critical data and endpoints. You can configure your tier preferences at the visit, form, and even field level data giving you complete control. Monitors are often faced with working in solutions that require them to figure out what patients, forms, and fields to STV often via a spreadsheet and some algorithm outside of the EDC. TSDV is fully unified with Ravey. So through the use of dynamic task lists, monitors can quickly focus on the patients, visits, and forms they're interested in. TSTV is easy to use, set up, and modify as study data starts coming in from the sites. No matter what level of source data verification your study requires, our solution allows for flexible designs to support your needs. Users also have instant access to change the review plan as the study evolves, ensuring you're focusing your efforts on the highest impact areas. Using a combination of out of the box and custom tiers, you can design the review plan that best meets your study needs. And while the solution will automatically assign patients based on triggers you define, You can automate reassignment of patients based on custom rules, but also allowing you full manual override. TSDV makes your team more efficient. It improves the safety of your patient. It focuses efforts in the right areas to ensure you have success with your clinical trial efforts.

基于风险的 SDV策略

TSDV 将 SDV 升级为一种结构化、基于风险的执行策略。您可以结合研究层级的风险评估,灵活定义具体的核查数据、层级及目标范围。

TSDV 直接内置于 Rave中,支持针对特定研究和研究中心定制 SDV 战略,同时确保全面覆盖关键安全性和有效性数据。

关注关键数据
稽查就绪
研究与中心定制化SDV
字段级核查

精简 SDV 策略实践

降低监查成本

控制因 SDV 产生的监查成本

彻底告别 100% SDV,仅在风险策略要求的关键节点执行核查。通过减少不必要的核查工作及现场访视,您可在不削弱监督力度的同时,显著降低监查成本。

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将 SDV 比例从 50% 降至目标15%–20%

Nordic Bioscience 采用 Medidata TSDV 替代了手动 SDV 追踪,并试行了真正基于风险的监查。结果表明:此举不仅显著优化了研究执行流程,更为其开辟了一条将 SDV 比例降至 15%–20% 的可行路径,并且显著节约成本。

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常见问题

Medidata TSDV 支持研究团队将源数据核查(SDV)的精力聚焦于关键质量数据,而非开展 100% 全量核查。鉴于传统 SDV 通常会消耗超过 50% 的研究中心监查预算,这种目标核查方法能够显著减少临床监查员(CRA)在低价值数据核查上投入的时间,从而在确保数据质量不受影响的前提下,显著降低整体监查成本。

可以。Medidata TSDV 支持针对特定研究和研究中心灵活配置SDV 计划。您可以将核查要求细化至具体的数据字段、表单以及患者访视层级,从而针对每个研究中心量身定制契合其风险特征的 SDV 策略。

是的。该解决方案旨在全面支持 ICH GCP E6 (R2)、E8 (R1) 以及 (R3) 合规。它支持研究团队将基于风险的方法应用于临床运营中,同时自动留存完整且具备稽查就绪状态的审计追踪,准确记录已核查与未核查的所有内容。

Medidata TSDV 与 Rave 以及 Medidata Platform 实现了完全一体化。这意味着,CRA 可以直接在日常工作流中,精准定位并核查所需的目标字段;同时,研究经理也能在整个试验生命周期中,全面把握 SDV 进度与任务分配。

是的。Medidata 为客户及合作伙伴提供多种培训方案,包括自学课程与讲师授课课程。如需查看可用课程并获取相关资源,请访问 Medidata 全球教育与培训中心。

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