NCT03946501

Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: CHU de Reims · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clinical Research Inclusion

Interventions

Type	Name	Description
OTHER	Data collection

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2019-05-10
• Last updated: 2019-05-10

Locations

1 site across 1 country: France