Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff (CRA-MD)

CHU de Reims

Status: Completed

Conditions: Clinical Research Inclusion

Treatments: Other: Data collection

Study type: Observational

Funder types: Other

Identifiers

NCT03946501

2018Ao003

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

400 participants in 1 patient group

clinical research visit

Treatment:

Other: Data collection