Evaluation of Efficacy and Cost of Two Monitoring Strategies for Public Clinical Research - OPTIMON: Optimisation of Monitoring for Clinical Research Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Proportion of patients' file without severe error.
研究概览
简要总结
OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the classic standards of quality assurance, and the other one being a priori "optimized" on the main scientific and regulatory principles.
详细描述
There is no validated standard of monitoring strategy for clinical research studies. Optimon will compare two monitoring strategies - a classical strategy based on the practices of the pharmaceutical industry, and an optimized strategy based on patient's risk level - on their ability to produce exact data, focusing on the main quality criteria: regulatory requirements and scientific validity of results. Optimon is a non inferiority randomized trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical Research Studies: risk level A, B, or C in the Optimon risk-assessment scale, with or without a sponsor and the advice of an ethical committee, starting in 2008 and ending before the end of 2010, with a foreseen accrual of 20 patients or more, multicentric with at least 4 clinical sites, with a paper or electronic CRF, with the participating agreement of the coordinating investigator and the sponsor.
- •Clinical sites: Sites with a foreseen accrual of 5 patients at least, with the participating agreement of the principal investigator.
- •Clinical Research Units: with the label of an institution, with at least 2 years of experience in multicentric studies, with SOPs finalized before 2008, willing to participate in Optimon.
排除标准
- 未提供
结局指标
主要结局
Proportion of patients' file without severe error.
时间窗: at end of follow-up
次要结局
- Compounds of the main outcome, other errors, delay to get the results, costs(at end of follow-up)