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

  • identifier


  • Recruitment Status


  • First Posted

    May 10, 2019

  • Last update posted

    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 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.

Study Design

  • 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 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
  • 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


Inclusion Criteria:

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

Contacts and Locations



Damien JOLLY

Sponsors and Collaborators

CHU de Reims

More Information