Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Missing data
研究概览
简要总结
The aim of the study was to evaluate the interest of the recourse of a staff dedicated as CRA to data collection in clinical research
详细描述
Objectives of clinical studies are notably to evaluate new therapies, to improve diagnostic techniques, to make medico-economic decisions and to enrich scientific knowledge. Clinical studies findings can influence medical practice, or even motivate decisions by public health authorities. The rigor in their behavior is therefore an imperative to respect.
Thus, the quality of the data collected is essential. However, even if the reliability of the clinical data is guaranteed by the monitoring, the completeness of the data remains exceptional.
The increase of data required in clinical studies has led to the emergence of a specialized staff to assist investigators: the clinical research assistants. With dedicated time and specialization in data collection, they facilitate the conduct of clinical studies. However, this data collection aid has not been evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical research visit performed in Reims university hospital between January 2010 and January 2015
排除标准
- 未提供
结局指标
主要结局
Missing data
时间窗: Day 0
Data was considered missing because of its absence when finalizing the data
次要结局
未报告次要终点