QUALITÉ DE LA RECHERCHE :  TRANSPARENCE, REPRODUCTIBILITÉ ET DOCUMENTATION DES PROCESSUS
Creators: name: Lebrand, Cécile
Publisher: name: Zenodo
Year: 2025
Subjects: subject: FAIR Data Sharing
subject: Educational sciences
subject: FOS: Educational sciences

description: Le Centre de recherche clinique CHUV-FBM (CRC), en collaboration avec la Commission cantonale d'éthique de la recherche sur l'être humain (CER-VD), le Département d'épidémiologie et systèmes de santé (DESS) d'Unisanté, Centre universitaire de médecine générale et santé publique et Le Centre des formations du CHUV, proposent ce cours qui s'adresse particulièrement aux professionnel-le-s de santé souhaitant remplir les rôles de promoteur-trice dans le cadre de recherches cliniques interventionnelles (essais clinique; formation requise par swissethics) dans la direction de projets de recherche observationnels (cohortes, études rétrospectives; formation recommandée par swissethics)

Ce cours permet d'acquérir les connaissances de base nécessaires à la conception, à la réalisation pratique et à la gestion d'études cliniques. Plusieurs intervenant-e-s, représentant les disciplines et professions clés de la recherche clinique, animeront ce cours.

Plusieurs offres de formation sont disponibles en fonction des acquis préalables des participant-e-s:

Recherche clinique - Devenir investigateur et investigateur/promoteur : 3 jours

Recherche clinique - Devenir investigateur : 2 jours

Recherche clinique - Complément pour devenir Investigateur/promoteur: 1 jour (Prérequis exigé : attestation de participation antérieure aux jours 1-2 ou formation équivalente agréée swissethics)
description: Data Sharing Requests and Procedures

Researchers interested in accessing data can request the necessary Data Transfer and Use Agreement (DTUA), via the Principal Investigator. Upon request, the scientific committee will evaluate the application. If accepted, the data will be extracted from the Horus CHUV Dataset Catalog at DSI-CHUV, under the supervision of the Principal Investigator.


Requirements for Data Access

Researchers who wish to analyze, reproduce, or gain further insights from the data must submit a request for de-identified patient-level data to heads of the current project. Requests must clearly justify the use of the data and specify the required variables. External users or collaborators should demonstrate a proven track record in the field, provide a detailed research protocol, and explain how they will handle the data ethically and scientifically.

The protocol should include:



    
Collaborators and their affiliations
    
Potential conflicts of interest
    
Project funding details
    
Inclusion/exclusion criteria
    
Scientific questions to be addressed
    
Detailed analysis plan
    
Peer-reviewed publication in the field



Approval Process

The heads of the current project will review the application, recommending any necessary protocol adjustments to enhance quality and ensure alignment with project objectives. Before the data is released, both parties will sign the Data Transfer and Use Agreement (DTUA) based on the Swiss Personalized Health Network (SPHN) template. This agreement will define responsibilities related to data protection, management, authorship (in accordance with international standards), and the proper citation of sources and funding. Additionally, it will specify the required date for secure data destruction after analysis is completed, with confirmation of destruction submitted to the project leads.



To get access to the dataset, please contact the following email:


cecile.lebrand@chuv.ch