Clinical Research and Data Collection During the Investig... | NCT03946501

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

NCT03946501

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

May 10, 2019Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Clinical Research Inclusion

Interventions

Data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2015Actual

Primary Completion Date

Apr 1, 2015Actual

Completion Date

May 1, 2015Actual

First Submitted Date

May 9, 2019

First Submission Date that Met QC Criteria

May 9, 2019

First Posted Date

May 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2019

Last Update Posted Date

May 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Label	Type	Description	Intervention Names
clinical research visit			Other: Data collection

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other		clinical research visit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Missing data	Data was considered missing because of its absence when finalizing the data	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

clinical research visit performed in Reims university hospital, with or without the help of a clinical research assistant

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29198734	Background	Ghenim S, Feron 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.

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care