Completed

NCT Number: NCT03946501

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

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

Completed

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Key information

Conditions

Clinical Research Inclusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Damien JOLLY

Reims, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

clinical research visit performed in Reims university hospital between January 2010 and January 2015

Treatment and study plan

Data Collection

Other

Primary outcomes

Missing data

Time frame: Day 0

Data was considered missing because of its absence when finalizing the data

Sponsors and collaborators

Lead sponsor

CHU de Reims