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

Clinical Research Inclusion Clinical Trial

— CRA-MD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946501
• Other study ID #: 2018Ao003
• Status: Completed
• Start date: March 1, 2015
• Est. completion date: May 1, 2015

Study information

• Verified date: May 2019
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 1, 2015
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Clinical Research Inclusion

Intervention

Other:
• Data collection

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Ghenim S, Féron 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Missing data	Data was considered missing because of its absence when finalizing the data	Day 0