Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff
- Conditions
- Clinical Research Inclusion
- Interventions
- Other: Data collection
- Registration Number
- NCT03946501
- Lead Sponsor
- CHU de Reims
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- clinical research visit performed in Reims university hospital between January 2010 and January 2015
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description clinical research visit Data collection -
- Primary Outcome Measures
Name Time Method Missing data Day 0 Data was considered missing because of its absence when finalizing the data
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Damien JOLLY
🇫🇷Reims, France