Access to Epipage 2 data

 

A database open to the scientific community

The data from the Epipage 2 study are accessible to any public or private research team, French or foreign, on the basis of a research project and under the conditions specified in the data access charter.

The new law for modernisation of the French Public Health System voted in 2016 now provides a legal framework for access to already collected cohort data by complying with ‘reference methodologies’.

The research teams that helped set up the Epipage 2 study have priority in accessing the databases. They are therefore granted exclusive access to the data for a period of 18 months from the date on which the data are made available for each phase of the survey. After this period, the data are made available to the entire research community.

Regarding data access by industrial users, the management teams have asked Inserm Transfert, INSERM’s private subsidiary, to draw up partnership models covering all concerned parties. Inserm Transfert handles negotiations with industrial users with regard to data access rights, intellectual property and valorisation.

 

How do I apply?

To request access to Epipage 2 data :

  • Complete the downloadable project form here
  • Send the form to This email address is being protected from spambots. You need JavaScript enabled to view it.
  • In turn, annotated questionnaires and dictionaries will be sent to you for selection of the variables needed for analysis. Annotated dictionaries should be returned to the above address.
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    Evaluation of data access request

    Only non-nominative data defined as having a low re-identification risk are accessible. Each application is evaluated by two committees:

  • The Scientific Committee (SC) is a group of epidemiologists, pediatricians and obstetricians that assesses the scientific relevance of the application.
  • The Data Access Committee (DAC), composed mainly of statisticians and data managers, provides technical support to the scientific group.
  • The following criteria are used:

  • methodological strengths and weaknesses (feasibility, choice of methods to achieve the objectives)
  • absence of overlap with other ongoing projects, in which case discussions with the different teams are organized.
  • relevance of the requested data for the project and respect for confidentiality and compliance to the CNIL Reference Methodology MR-004.
  • After approval by the Scientific Committee (SC) and the Data Access Committee, the principal investigator is requested to sign a letter of commitment before the data can be made available.

    In case of international collaborative projects, a data sharing agreement and specific regulatory authorizations are needed.

    The data are transmitted within a month on average. Records are kept of all authorized or refused data access requests. This time frame may be longer for international teams due to the need to establish data sharing agreements.

    The principal investigators are requested to inform the scientific group of the progress of the analyses and to submit any draft article, written or oral communication to the scientific group before submission.

     

    How to make a joint request for Epipage 2 and Elfe data?

    The Epipage 2 and Elfe cohorts, a generalist cohort of term-born children (https://www.elfe-france.fr/) are collaborating in the RECONAI project to provide a platform for research on cohorts of children followed since birth.

    As part of this project and since its implementation, the two cohorts, Epipage 2 and Elfe, have pooled a number of objectives and data collection tools, adapting them to the specificities of each population (premature and full-term children).

    For any project involving both cohorts, it is necessary to submit your project to each cohort.

    For Epipage 2, according to the procedure defined above,

    For Elfe, please follow the instructions here (https://pandora.vjf.inserm.fr/public/).

    The project will be evaluated by each cohort and by a data access committee common to both cohorts.

     

    Data currently available

     Study protocol

    Data collected at birth

    Data from maternity medical records

    Neonatal Medical Record Data

    Interview with the mother

    Self administered questionnaire completed by the mother

    Data collected at 1 year of age corrected

    Questionnaire completed by parents

    Data collected at 2 years of age corrected

    Questionnaire completed by parents

    Questionnaire completed by the child’s treating physician

    Data collected from health services involved in recruitment

    Maternity ward

    Neonatal unit

    Bâtiment Recherche - Hôpital Tenon
    4, rue de la Chine 75970 Paris Cedex 20