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

NCT ID: NCT03946501

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-01

Study Completion Date

2015-05-01

Brief Summary

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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

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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

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Clinical Research Inclusion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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clinical research visit

Data collection

Intervention Type OTHER

Interventions

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Data collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- clinical research visit performed in Reims university hospital between January 2010 and January 2015
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status

Countries

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France

References

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Ghenim S, Feron T, Barbe C, Wolak-Thierry A, Jolly D. [Clinical research and data collection during the investigation: Influence of a dedicated staff]. Therapie. 2018 May-Jun;73(3):267-272. doi: 10.1016/j.therap.2017.10.003. Epub 2017 Nov 11. French.

Reference Type BACKGROUND
PMID: 29198734 (View on PubMed)

Other Identifiers

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2018Ao003

Identifier Type: -

Identifier Source: org_study_id

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