Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff identifier recruitment status First Posted Last update posted
NCT03946501 Completed May 10, 2019 May 10, 2019

study description
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: Clinical Research Inclusion
Intervention/treatment: Other: Data collection
Phase: N/A
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

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.

study design
Study Type: Observational
Estimated Enrollment : 400 participants
Intervention Model : N/A
Masking: N/A
Primary Purpose: N/A
Official Title: Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff
Actual Study Start Date: March 2015
Actual Primary Completion Date: April 2015
Actual Study Completion Date: May 2015

Groups and Cohorts
Groups/Cohorts Intervention/treatment
: clinical research visit
Other: Data collection
outcome measures
Primary Outcome Measures: 1. Missing data [ Time Frame: Day 0 ]
Data was considered missing because of its absence when finalizing the data

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations
France Damien JOLLY Reims
Sponsors and Collaborators
CHU de Reims
More Information
Other Publications

Ghenim S, FĂ©ron 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.

Responsible Party : CHU de Reims Identifier : NCT03946501     
Other Study ID Numbers : 2018Ao003
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Last Verified : May 2019
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims: clinical research
missing data
clinical research assistant