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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03946501
Acronym
CRA-MD
Enrollment
400
Registered
2019-05-10
Start date
2015-03-01
Completion date
2015-05-01
Last updated
2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Research Inclusion

Keywords

missing data, clinical research, clinical research assistant

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

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.

Interventions

OTHERData collection

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Missing dataDay 0Data was considered missing because of its absence when finalizing the data

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026