#  _1.2. Reused data and its origin_

The only data that will be taken from previous records will be the clinical
records of the patients that are included in the study. The origin of the data
comes from the different tests, questionnaires and interviews conducted with
the study patients.

#  _1.3. Estimated size of the data_

The data that will be collected will be mainly the clinical data per patient.
It is estimated that its total size is around 2GB.

#  _1.4. Usefulness_

The usefulness of the data extracted from the project is expected to benefit
mainly:

  * The Bionic **\VEST** consortium 

  

  * European Commission services and European Agencies 

  

  * EU National Organisms 

  

  * The general public including the broader scientific community 

  

#  FAIR Data

The data produced and / or used in the project are detectable with metadata,
identifiable and locatable by means of a standard identification mechanism
(PIDs) and unique as the Digital Object Identifiers that will allow its search
within the repository of the Bionic **\VEST** project.

##  Naming conventions

For metadata, dataset and template names we will define naming convention
consisting in 3 mandatory parts:

  * A prefix, indicating if it is a dataset, a metadata or a template  A root composed by: 

    * the short and meaningful name of the dataset/template 

  

    * the acronym/short name of the data provider organisation(s) (Bionic **\VEST** by default for templates) 

  

  

  * A suffix indicating the date of the last upload into the Repository in YYYYMMDD format. 

  

Each of these elements are separated by an underscore: _

In addition to this, search keywords will be provided that optimize the
possibilities of reuse.

The Naming convention will be applied to the version in management of the
data, metadata template and in general the files stored into the Repository
and the use of the date as suffix, indicating the last version of the file
uploaded into the Repository.

##  Making data openly accessible

The data will be directly accessible via Bionic **\VEST** repository to the
Bionic **\VEST** consortium partners.

To share data with Bionic **\VEST** consortium partners, a repository has been
set up. This provides access, password protected, to the data through a web
interface to view, upload and download the files across the users easily.

The Bionic **\VEST** repository has been set up for this project as it:

  * Is a platform that facilitates sharing of data, intermediate results, and results 

  

  * Is developed by the ULPGC as one of the partners of the Bionic **\VEST** project. So changes can be done to improve the outcomes. 

  

  * Is needed to enable the analysis of vestibular implant data, but also to meet the goals of Bionic **\VEST** dissemination goals. 

  

  * Enables that Data Owners/Data Providers can choose to which research they will contribute with their data; that use of the data can be detailed, diversified, and flexible according to the purpose and the interests of the Data Owners/Data Providers. 

  

  * Will reach the GDPR compliancy by: 

  

o Logging of user identity during data access, download, and upload, including
version control. This enables to restore the availability and access to the
data in a timely manner in the event of a physical or technical incident.

For data generated with Bionic **\VEST** co-fund during the course of Bionic
**\VEST** , the Data Owner/Data Provider shall agree that these data are
transferred at high level of granularity to the Bionic **\VEST** repository
(single measurement data in an anonymised or pseudonymised way); and that the
accompanying variables of the study that are needed to solve the envisaged
research purpose(s) are also provided as single measurement data.

##  Making data interoperable

All the data generated and software applications are standard elements in the
field of treatment and diagnosis of vestibular pathology. For this we follow
the guidelines published by the Bárány Society.

Likewise, the vocabulary, standards or methodologies of metadata and data
follow those described by the Bárány Society so that their data are
interoperable

On the other hand, it will use standard vocabularies for all types of data
present in its data set, to allow interdisciplinary interoperability.

##  Increase data re-use

This section will be compiled throughout the course of the project, when we
get more information on the datasets that are made available forBionic
**\VEST** .

#  Allocation of resources

The maintenance of the project website with its annual repository maintenance
repository will be around € 500 / year.

Maintenance costs are covered by direct costs of the website for the Bionic
**\VEST** project.

The management of the data is the responsibility of the partners ULPGC and
SCS.

The data will be maintained once the project has been completed for 4 years in
the Bionic **\VEST** repository. Once the term has expired and if the
repository is not maintained, a copy of the data will be stored in the raw
form by each one of the partners of the Bionic **\VEST** consortium.

#  Data security

The repository is under SSL encryption. Likewise, the data that is loaded into
the repository will be anonymous. On a daily basis, the repository generates
an incremental backup of the data, structures of the database as well as the
users.

#  Ethical aspects

The transfer of data on human subjects to the Bionic **\VEST** repository is
only considered when the following approvals are in place:

  * informed consents, 

  

  * ethics approval and 

  

  * approval by local data protection authorities if applicable. Such an approval will cover the purpose of the data to be used within Bionic\VEST and allows for transfer of individual or aggregated data to the Bionic **\VEST** repository. 

  

The informed consents will be stored by the partner's center where the patient
comes from.