#  EXECUTIVE SUMMARY

Metabolic effects of Endocrine Disrupting Chemicals: novel testing METhods and
adverse outcome pathways (EDCMET) is a research project supported by the
European Commission’s Horizon 2020 research framework (825762). The project
responds to call H2020-SC1-2018-Single-Stage-RTD, programme H2020-EU.3.1.1 –
“Understanding health, wellbeing and disease”, topic SC1-BHC-27-2018 “New
testing and screening methods to identify endocrine disrupting chemicals” and
is active between 1.1.2019-31.12.2023.

EDCMET brings together experts in various research fields, including systems
toxicologists, experimental biologists with a thorough understanding of the
molecular mechanisms of metabolic disease and comprehensive _in silico_ , _in
vitro_ and _in vivo_ methodological skills and ultimately, epidemiologists
linking environmental exposure to adverse metabolic outcomes. The project
focuses on developing novel test methods and models to assess the metabolic
effects of EDCs. Combined _in silico_ , _in vitro_ and _in vivo_ methods are
developed with an emphasis on liver and adipose tissue and endocrine pathways
related to their metabolism. In addition, epidemiological and field monitoring
data is used to gain information regarding the exposure to chemicals and EDC-
related metabolic effects. The interdisciplinary approach and complementary
expertise of the participants will identify novel mechanisms of action, and in
collaboration with the European Commission (EC) Joint Research Centre (JRC)
providing an interface between the programme and European regulatory agencies,
novel validated test methods for regulatory purposes will be generated.

Efficient and secure data management, including collection, integration and
sharing of data, is the very essence of large-scale multidisciplinary research
projects such as EDCMET that collects and integrates data from different
sources including various high-throughput technologies. This data management
plan (DMP) is produced as part of the Open Research Data Pilot (ORDP). It sets
the framework for the handing of data produced in EDCMET project from
acquisition over curation to dissemination and shall thereby assure the
implementation of best practical procedures for the management and
accessibility of EDCMET data during and beyond the lifetime of the project.

This deliverable (D6.1, month 3) provides the first issue of the DMP and the
initial approach to the handling of research data during and after the end of
the project, data collection, generation and processing, data standards and
methodologies, open access as well as data curation and preservation. As a
living document, the

DMP will further evolve throughout the lifespan of the project.

#  PURPOSE OF THE DMP AND RESPONSIBILITIES OF PARTNERS

The purpose of this DMP s to provide main elements of the data management
policy used by the EDCMET consortium regarding project data. The DMP covers
the complete project and research data cycle. It describes the types of data
that will be generated, collected, processed and re-used during the project,
the standards that will be used, how the data will be preserved, and which
parts of the data will be shared for verification or reuse. It also reflects
the current state of consortium agreements on data management and must be
consistent with exploitation and IPR requirements.

EDCMET includes four scientific work packages (WP1-4) and four work packages
related to management, dissemination and ethics (WP5-8). The WP6 (Data
management, UEF) has an overall responsibility of the data management and to
ensure that the shared data are easily available, that proprietary data are
secured and that regular backups are performed. In the frames of project data
management, each EDCMET partner must respect the policies and responsibilities
set out in this DMP and follow best practices for data generation, storage and
sharing. Further, each partner shall follow their national and institutional
procedures for data management, when applicable and/or required.

Datasets must be created, managed and stored appropriately in line with
applicable legislation and the DMP. Quality control of the data, according to
the EDCMET quality assurance protocols and GLP principles, is the
responsibility of each partner and ultimately of the WP leaders and project
management team (UEF). Further, each WP leader will ensure dataset integrity
and compatibility for its use during the validation of tools by different
partners. Registration of datasets to the common data repository and
accompanying metadata, according to unified naming conventions and ontologies,
is the responsibility of the partner that generates the data. If datasets are
updated, the partner that possesses the original and updated data has the
responsibility to manage the different versions and to make sure that the
latest version is available within EDCMET and EURION networks as well as for
sharing through open access repositories, depending on the data and phase of
research. All researchers and partners involved in data gathering, generating
and processing shall become familiar with the EDCMET data management policies
and guidelines of open access issues. Data is owned by the partner that
generates them. A partner may transfer ownership of the data as agreed in the
Consortium Agreement (CA). Each partner must continuously identify and protect
valuable intellectual property rights and to identify opportunities to exploit
the data. Also, prior notice of any publications or public presentations must
be given according to the CA.

The document will evolve during the project and will be updated and ultimately
completed accordingly, as research data is collected or when significant
changes in consortium policies or composition arise. At minimum, it will be
updated in _**M6** _ according to H2020 guidelines and as part of the mid-term
and final project reports.

#  DATA SUMMARIES

As the first version of the DMP is due in month 3, precise and more detailed
information related to the data collected and generated by EDCMET, applied
data standards, harmonization and accessibility of research data as well as
confidentiality levels of each dataset will be given in later versions of the
DMP.

##  Purpose of data collection/generation and data utility

The main objective of the EDCMET project is to develop validated _in silico_ ,
_in vitro_ and _in vivo_ methods assessing the metabolic effects of EDs in
line with the OECD work on endocrine disruption. Further, the aim is to follow
the traditional adverse outcome pathway (AOP) paradigm to identify molecular
initiating events and predict the emergent adverse biological phenotypes. A
prerequisite to achieve these aims, is to coordinate the data collected at
individual EDCMET WPs by different research organizations and groups and to
make them openly available. To this end, the EDCMET data management aims to
integrate datasets to enable and simplify the access and utilization of data
for different stakeholders within various scientific and operational
communities.

Data will be made available for the members of the project as well as to the
broader research community through open access repositories or other channels
as described in the DMP. As the EDCMET members are from eight different
countries in Europe with extensive scientific and other stakeholder networks,
each partner is expected to increase awareness and support co-operation within
the field. EDCMET WP5 as well as the EURION cluster will continuously search
and evaluate potentially relevant stakeholders to maximally enhance the impact
of the project findings for both scientific and regulatory purposes. Tailored
information will be provided to different stakeholders, based on the developed
dissemination and communication strategy and tools, while respecting all
ethico-legal framework. The data collected and generated in the project are
likely to be useful at least to the following general categories of
stakeholders (living list):

  * EDCMET consortium and EURION cluster members 

  

  * Regulatory agencies and authorities 

  

  * Policy makers and funders 

  

  * Academic researchers and other scientific experts 

  

  * Industry 

  

  * Members of the public 

  

##  Origin of the data

EDCMET uses a variety of methodologies for novel and improved approaches to
assess the metabolic effects of endocrine disruptors (EDs), ranging from _in
silico_ and omics to _in vitro_ and _in vivo_ , and ultimately,
epidemiological data to associate exposure levels to ED-related metabolic
effects. The data produced during the project are based on the Description of
Action (DoA) and the results/deliverables from individual WPs. The data
generated by EDCMET strongly depends on the individual tasks, tools and
research methods used within WPs. In WPs 1-3 the data will be mainly collected
and produced by various _in silico_ , _in vitro_ and _in vivo_ methodologies
during the project. Literature and public databases will be used to generate a
list of omics datasets of relevant experiments. EDCMET research involving work
human data (WP4) includes secondary use of information obtained from existing
cohorts within EU.

In a scientific context, research data refers to information, facts or numbers
collected and generated within the frames of the project (raw data), which
will be further analysed and processed (processed data). The focus of this DMP
is on research data that is available in digital form. However, short
descriptions for management and dissemination document formats and storage are
also included in the DMP.

##  Data types and formats

A list of main categories and types of data generated, collected and re-used
during the project are listed in _**Table 1** _ according to work packages
(WP1-8). This list will be adapted and extended with the addition datasets as
well as more detailed description of data types and file formats in further
versions of the DMP, based on project developments.

**Table 1. Main categories and types of data in EDCMET**  
  
<table>  
<tr>  
<th>

**WP**

</th>  
<th>

**Main types of data**

</th> </tr>  
<tr>  
<td>

**1**

</td>  
<td>

Several datasets derived from _in silico_ and omics analyses.

</td> </tr>  
<tr>  
<td>

**2**

</td>  
<td>

Data from _in vitro_ laboratory measurements.

</td> </tr>  
<tr>  
<td>

**3**

</td>  
<td>

Data from _in vivo_ animal experiments.

</td> </tr>  
<tr>  
<td>

**4**

</td>  
<td>

Data from epidemiological studies (cohorts).

</td> </tr>  
<tr>  
<td>

**5**

</td>  
<td>

Data related to dissemination activities, such as publications, presentations,
posters, seminars, brochures, newsletters, templates and logos

</td> </tr>  
<tr>  
<td>

**6-8**

</td>  
<td>

Management files, project rules and follow-up data including Grant and
Consortium Agreements, Gantt chart and action plans, administrative and
financial data

</td> </tr> </table>

The multidisciplinary approach of the project will generate large amounts of
new data from different experimental approaches. Such data include for example
graphics, microscopic graphs and imaging data, selected numerical data from
laboratory measurements, analyses and high-throughput technologies,
statistical data _etc_ . Data from the scientific WPs (WP1-4) will vary in
terms of raw and processed data formats, depending on the instrumentation and
software used to measure and analyse/process the data. Detailed identification
and descriptions of used instrumentation, software and resulting data formats
as well as confidentiality levels of datasets, will be included in the
accompanying metadata ( _**Section 2.4** _ ) in the later versions of the DMP,
when appropriate. To ascertain the data quality, performance of experimental
instruments and systems will be checked regularly with standardized controls
and procedures, as per the rules and instructions of the relevant institutes
and/or EDCMET quality assurance procedures. Final data will be saved in an
open file format ( _e.g._ .csv, Office documents, .pdf/a) whenever possible to
enable further data sharing. Possible data conversions shall be managed by the
researcher who has produced the data, to ensure data integrity. Where
applicable, data formats may be migrated when new technologies become
available and are proven robust enough to ensure digital continuity and
continued availability of data or when the appropriate software is freely
available or included.

Generally, all data falling under management category (WPs 6-8) as well as
majority of data produced by dissemination activities (WP5) will be available
in .pdf/a format. Further data types from WP5 may include for examples graphic
images, such as the project logo, or presentations and posters. EDCMET has
agreed that each member uses templates from their own institutes for
presentations and posters, while including relevant project and EU logos and
descriptions. Reports by each partner will be produced using a unified
template and format generated for the project. Scientific publications will
follow the format required by the conferences or journals in which said
publications will appear.

##  Data standards and metadata

At this stage of the project ( _**M3** _ ), a detailed data harmonization
process is being constructed. This will be achieved through collecting
information on the data produced within EDCMET by all partners as well as
coordination of the activities of WP1 to draft standard formats, naming
conventions, keywords, ontologies and metadata standards or alternative
approaches. Existing metadata standards can be used, if applicable. Further,
on-going standardisation efforts conducted _e.g._ in eTOX and ECETOX, include
_e.g._ data dictionary standard loaders for MeSH terms, UniProt proteins, Gene
Ontologies, AOP-wiki _etc_ . Considering the strongly interdisciplinary nature
of EDCMET as well as various data types produced within the project by
significantly different methodologies and _e.g._ frequently changing software
versions, a unified approach may include a set of common elements,
complemented with more detailed dataset or methodology -specific elements.
Consistency between similar data sets will be sought.

##  Expected size of the data

At this stage of the project ( _**M3** _ ), the precise total volume cannot be
determined but it is reasonable to assume that it will reach several tens of
terabytes (Tb, midterm) due to extensive use of _in silico_ and omics
methodologies.

#  DATA STORAGE AND ARCHIVING

##  Internal (midterm) data storage and sharing

The overall data produced and/or collected by each EDCMET partner must be
carefully stored. In a preliminary stage of data collection or generation,
local/institutional secured data repositories can be used. During the project,
all non-sensitive data and protocols shall be carefully stored by respective
authors or organizations in the common (midterm) data repositories, dedicated
to the EDCMET project and managed by the coordinating institute (UEF), at
secure CSC servers ( _**Table 2** _ ). Templates for storing the data,
including clear versioning, as well as detailed structures and properties of
the repositories are under construction. They will be disseminated to all
partners and included in the later versions of the DMP. This will facilitate
document evaluation and review and ensure standardization as well as required
compatibility with data and repositories from the EURION cluster. Further,
special agreements will be established to ensure data and protocol transfers,
as required. In general, data shall be preferably shared within EDCMET via
indication of its placement in the repository.

Access to EDCMET midterm data repositories will be granted per request and by
the Scientific Manager. The contents of the midterm repositories can only be
accessed by authenticated members of the EDCMET project and by default, access
to all datasets will be granted to all partners, unless a limited access is
requested and justified by the owner of the dataset. Cases where access to
specific background is subject to legal restrictions or limits are specified
in the CA and will be handled case-by-case. All project members have equal
rights to add, remove, and operate on project data stored in the IDA
repository but care must be taken, that no changes to data owner by other
partners are to be made. Each repository user must verify that the data and
documents uploaded to the repository follow the standards set for EDCMET data
( _**Section 2.4** _ ). The repository users are required to follow
announcements and provided schedules on CSC server maintenance periods. The
users will be promptly informed on any unplanned interruption of services.

**Table 2. Midterm data storage and sharing**  
  
<table>  
<tr>  
<th>

CSC-IDA

ida.fairdata.fi

</th>  
<th>

Continuous service for safe data storage organized by the Finnish Ministry of
Education and Culture. The midterm storage area is for new data for collecting
and organizing data during the project. This area is not visible to other
services or users than the EDCMET/EURION participants with granted access by
the Scientific Manager. The frozen area (read-only) of the EDCMET database is
meant for final data, which are given unique identifiers and metadata stored
in metadata repositories and linked to other Fairdata services. The current
data repository can host 10 Tb of data but can be extended depending on the
project needs. IDA is not optimized for data under heavy usage for which the
Object Storage is a better option.

</th> </tr>  
<tr>  
<td>

CSC-Object Storage

(cPouta)

</td>  
<td>

The Object Storage functionality is a cloud storage service, provided for the
public could cPouta IaaS cloud computing platform. Object storage can be used
for large datasets or intermediary (unstructured) results that a lot of nodes
need to access, to share data and results within the project or with other
projects over https. The Object Storage is especially suitable for pushing big
data temporarily from different groups within EDCMET for later processing and
computing.

</td> </tr> </table>

Public and base protection level data, such as management and dissemination
documents will be stored in the EDCMET collaboration platform in Office365
environment at UEF and shared, as applicable, on the EDCMET website. The
EDCMET midterm repositories are not suitable for sensitive personal data or
biometric identifiers (for these, see _**Section 5.2** _ ). Animal data will
be acquired in accordance with national and EU regulations for animal
experiments. Use and storage of these data do not have similar ethical
restrictions as human data and can be stored in the EDCMET repositories.

##  Public data sharing and reuse

When a dataset is ready to be published in an open repository or other public
space, _e.g._ after publication or after an assigned embargo period, the final
version of the dataset, following the established data and metadata standards
set up for EDCMET ( _**Section 2.4** _ ), shall be uploaded to the Frozen area
of the EDCMET IDA repository ( _**Section 3.1** _ ). The frozen datasets and
files are assigned PIDs and their metadata is stored in a centralized
repository. Checksums for frozen files are generated automatically. Further
Fairdata services, such as the metadata tool (QVAIN), research finder service
(ETSIN) and digital preservation services (FairdataPAS) will be used, when
available and applicable, to enable re-use and citations. Depending on the
dataset and ownership, the data can be further shared in other open access
platforms, such as OpenAIRE Zenodo. Machine-readable electronic copies of
published or final peer-reviewed manuscripts as well as suitable datasets or
metadata will also be deposited in institutional or national electronic
repositories, such as UEF eRepository (  _https://erepo.uef.fi_ )  . Attention
will also be given to ownership and intellectual property by establishing
rigorous rules and procedures for utilization and dissemination.

The tools and models produced in EDCMET will further made available to the
broad scientific community via high-impact peer-reviewed publications,
presentations at scientific meetings as well as existing networks of the
project partners. Significant scientific data will be published in journals,
which are in wholly open access and offer various open access modes ( _i.e._
gold or green routes or analogous modes). Open access publication will enhance
transformation of the results to other scientists and regulatory authorities.
EDCMET will also publish any public results through the project website (
_www.uef.fi/edcmet_ )  and diffuse or publish appropriate data via EDCMET
social media channels, such as Twitter (@edcmet_eu). The project partners are
encouraged to use social media and researcher networks (LinkedIn,
ResearchGate) to disseminate public data and results. The regulatory
implementation of the results will be achieved by consulting with national and
EU-level authorities and later, _e.g._ transforming the test systems or
characterized AOP pathways in the AOP-Wiki or Effectopedia (OECD). The EDCMET
consortium will also arrange conferences and workshops that are important
platforms to disseminate results and form scientific networks around endocrine
disrupters and health.

##  Archiving and long-term preservation

At the time of this first version of the DMP ( _**M3** _ ), data archiving
plans are preliminary and will be finalized when more accurate information on
the end volume of the collected and produced data allows definitions of the
long-term preservation procedures. By the end of the project, all final
datasets at CSC IDA repository will be frozen (unless frozen previously)
ensuring sustainable archiving of the final research data. The EDCMET data
repository will remain operational for 5 years after the project ends.

#  FAIR DATA

##  Making data findable

The EDCMET data management practices will follow the FAIR principles dictating
how the data will be Findable, Accessible, Interoperable and Re-usable.
Information on data documentation ( _**Section 2.4** _ ), such as used
ontologies, naming conventions, keywords and produced metadata will ensure
that the collected and generated data will be easily discoverable,
identifiable and locatable. Open data repositories providing PIDs and open
access publications will be used ( _**Sections 3.2 and 3.3** _ ).

##  Making data openly accessible

EDCMET will generate, collect and reuse a variety of datasets. During the
project, the data will be deposited in EDCMET midterm storages ( _**Section
3.1** _ ) and will be primarily shared among the project members. All
published research data will be open and available for shared use, if
agreements concerning ownership, rights to use, IPR and non-disclosure as well
as legislation and ethical principles allow it. The principles for sharing and
opening of research data in EDCMET is described in _**Section 3.2.** _

It is expected that all data related to public deliverables, social media,
courses or stakeholder events and open access publications will be made openly
available by default. As GWAS data, novel epigenetic data will be released,
after embargo (to be determined), into public databases. In certain cases,
such as with human epidemiological data, only metadata will be shared.
However, for example coded data can be pooled and analysed and may be
presented at scientific congresses and published in medical journals. Any
further information which must be kept confidential per request of any EDCMET
partner shall be clearly marked and justification as well as possible embargo
period for the dataset shall be provided. An embargo period may be requested
_e.g._ due to a planned publication, for allowing a PhD student to finalize
their thesis or to support IP protection or exploitation. In such cases, a
timeline for the release of the data shall be provided. Prior notice to
project members of any planned publication or opening of a dataset shall be
given according to the CA to avoid IP conflicts within EDCMET as well as
violation of rules of good scientific practice and protection of personal
data.

##  Making data inoperable

To allow data exchange and re-use between researcher, institutions,
organisations, countries _etc._ , EDCMET will assure the use of interoperable
formats ( _**Section 1.4** _ ). Standard vocabularies for all data types will
be used to allow interdisciplinary interoperability. A common vocabulary for
harmonising the descriptions of data and metadata are under definition and
will be available in the later versions of the DMP. In the case where less
common ontologies or vocabularies cannot be avoided or are specific to the
project or dataset itself, EDCMET will aim to provide mappings to more
commonly used ontologies. Certain datasets (omics, _in silico_ ) may be
accessible only using specific software, but this will be avoided as far as
possible. In such cases, the software in question as well as options for
access will be described or included, if possible. All such cases will also be
explained and justified in later versions of the DMP.

##  Increasing data re-use

Open data availability will be established as soon as possible while
respecting partner publication targets and requested embargo periods. As
sharing and promoting the re-use of data from EDCMET is believed to also
contribute to the dissemination of the developed methods and tools, and to
have a significant impact both in scientific as well as regulatory context,
EDCMET will always promote data re-use in a timely manner. As no research data
has been produced to date, re-usability by third parties or usability period
is not fully developed in the current version (v1.0) of the DMP. A general
overview of potential stakeholders is presented in _**Section 2.1** _ and will
be updated in the later versions of the DMP as the list of relevant
stakeholders (D5.2) and the EDCMET dissemination and communication plan (D5.3)
have been established.

Licences, such as Creative Commons CC BY 4.0 for open data and CC0 for
metadata, or other relevant licences, will be used. The owner of the dataset
will determine the type of licence used when data is added to EDCMET
repositories. A general archiving and long-term preservation plan for EDCMET
is presented in _**Section 3.3** _ . The quality control of each dataset is
ultimately a responsibility of all EDCMET partners, as described in _**Section
1** _ .

##  Allocation of resources

The coordinating partner, UEF, is responsible for the general data management
of EDCMET, as well as for the set-up and maintenance of the common data
repositories ( _**Section 1** _ ). UEF has allocated a partial salary of a
senior post-doctoral researcher (Scientific Manager) for data management
activities. The general responsibilities of EDCMET partners have been
described in _**Section 2** _ . EDCMET will use the free-of-charge CSC
services for data storage and (partial) processing. WP1 partners have
allocated additional funds for data processing and calculations for the _in
silico_ and omics approaches. Scientific publications, where the analyses of
the research data will be presented, will be published primarily in open
access journals and the costs related to open access will be claimed as part
of the H2020 grant as allocated in the budget. No data storage and
preservation nor data sharing arrangements at the EURION cluster level have
been made to date. When established and applicable, these will be included in
the later versions of the DMP. The EURION cluster collaboration on data
management will further benefit the data management processes of EDCMET.

#  DATA SECURITY AND ETHICAL ASPECTS

##  Data security

According to the general data protection regulation, each EDCMET partner is
responsible for data security of the midterm data they gather within their
organization and guarantee to meet the European data protection standards (
_e.g._ 201/69) within their organizations.

All local repositories are to be secured using the latest security protocols.
Each partner or organization is further expected to adopt a backup strategy
allowing for full recovery of the data in case of an event in which the
responsible person or location of the data storage is somehow compromised. By
means of example, the coordinating organization University of Eastern Finland
(UEF) complies with national and international information security laws and
regulations and implements the following approach: UEF runs its own
infrastructure with enterprise level disk storage and file servers located in
a physically secure data centers with appropriate fire suppression equipment.
All data storages and networks are located behind UEF institutional firewall
to protect against external attacks. The IT staff of UEF is responsible for
data security and protection, while implementing the following security
measures:

  * In-house servers controlled exclusively by UEF IT staff 

  

  * Password policy 

  

  * Regular updates of system and application software 

  

  * Timely installation of security patches 

  

  * Maintaining a level of preparedness for disturbances and exceptional situations based on _e.g._ risk surveys and audits 

  

The EDCMET will use CSC’s services of secure storage, backup and preservation
as well as transfer mechanisms. CSC information security management systems,
including cloud services, have an ISO/IEC27001 certificate. The data stored in
the EDCMET repositories are protected against unauthorized access by means of
Haka authentication or CSC accounts. Access to the repositories is restricted
to selected EDCMET members only and per request from the Scientific Manager
after agreement to terms and conditions set out in the CA and GA. Access to
EDCMET data by EURION members will be evaluated case-by-case basis to expedite
useful cluster collaboration while protecting the rights of EDCMET partners.
Further access restrictions can be put in place for confidential data per
request of the data owner. A detailed access policy as well as a tested backup
strategy allowing full recovery of data in case of a catastrophic event are
under construction and will be included in a next version of the DMP ( _**M6**
_ ).

##  Ethical aspects

In EDCMET, ethical standards and guidelines of H2020 will be rigorously
applied, regardless of the country where the research is carried out. All
EDCMET partners are required with the ethics of research integrity as
described in GA, as well as with national and international legislation
related to data collection, generation and re-use. Activities raising ethical
issues must comply with the Ethics requirements set out in the GA. WP8 will
follow-up the ethical issues applicable to EDCMET project implementation. As a
coordinating partner, UEF will ensure that all experimental work carried out
in EDCMET will comply with relevant guidelines and legislation and that all
data collection has been approved by local Ethical Committees. The Ethical
Committee approvals and personal training licenses will be stored on the
EDCMET data repository with access restricted to the management team or local
secure discs at UEF.

National Animal Experiment Boards of the corresponding countries will approve
protocols involving the use of rodents, which are applied for the project.
EDCMET will adhere to the EU GDPR (EU2016/679) on personal data protection as
well as to all relevant legislation and directives pertinent to the management
of human data. All data from previous cohorts, further processed during the
project, are treated as confidential and all data have been made pseudonymous
at the site of collection of the material, with only the cohort owner having
access to the key code list. The data is currently stored at secured
institutional servers by the respective cohort owners within the EU. The data
can be further hosted on a separate database (to be established as required)
meeting appropriate security standards and only coded data with variables at
the lowest possible resolution for analysis and with appropriate ethics
approvals may be shared with EDCMET partners solely for the purposes of this
project. A review of ethical issues related to the collected or generated data
will be carried out at month 6 of the project (D6.2) and all relevant
documentation will be made available to the European Commission by month 12 of
the project as agreed in WP8.