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

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ClinicalTrials.gov Identifier: NCT03946501
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Clinical Research Inclusion Other: Data collection

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.

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : April 1, 2015
Actual Study Completion Date : May 1, 2015

Group/Cohort Intervention/treatment
clinical research visit Other: Data collection



Primary Outcome Measures :
  1. Missing data [ Time Frame: Day 0 ]
    Data was considered missing because of its absence when finalizing the data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
clinical research visit performed in Reims university hospital, with or without the help of a clinical research assistant
Criteria

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946501


Locations
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France
Damien JOLLY
Reims, France
Sponsors and Collaborators
CHU de Reims
Publications:
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03946501    
Other Study ID Numbers: 2018Ao003
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
missing data
clinical research
clinical research assistant