<table>  
<tr>  
<th>

Task-1.1

</th>  
<th>

PUFA and pigment data

</th>  
<th>

Quantification of omega 3 PUFAs and pigments in the selected species biomass

(Excel and text files)

</th>  
<th>

Open access peerreviewed publication as supplementary

material

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

Task-2.1

</td>  
<td>

Comparative yields and size distribution of EV isolated and pre-concentrated
by

TFF

</td>  
<td>

Quantification of EV proteins (BCA) and size distribution analysis by NTA
(Excel and

text files)

</td>  
<td>

Open access peerreviewed publication as supplementary

material

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

Task-3.2

</td>  
<td>

Physical and

biochemical characterisation of EVs by microfluidic diffusion sizing

</td>  
<td>

Identification of vesicles by lipid and protein staining and of average
vesicle sizes

(Images and text files)

</td>  
<td>

Open access peerreviewed publication as supplementary

material

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

Table 2. Identification of key data sets relevant to year-2 of VES4US for
preservation and sharing

Relevant WP + task Data set designation Type of data and data files Outlet and
format for

preservation and

sharing  
  
<table>  
<tr>  
<th>

Task-1.2

</th>  
<th>

Differential EV content of best performing strain grown under varying
conditions

</th>  
<th>

Quantitative and qualitative analyses of EV content in cell-free cultivation
medium

(Excel and text files)

</th>  
<th>

Open access peerreviewed publication as supplementary

material

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

Task-4.2

</td>  
<td>

Qualitative and

quantitative characterization

data for functionalization of liposomal model systems according to a click
chemistry approach

</td>  
<td>

Quantification of functional groups (assays, Excel and Origin files), dynamic
light scattering data (raw data + Origin files), zeta potential measurements,
cryo-TEM images, characterization of modified antibody (SDSPAGE and
differential scanning fluorimetry), flow cytometry measurements

(raw data + origin files)

</td>  
<td>

Open access peerreviewed publication manuscript +

supporting

information and upload of raw data into open data

repository

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

Task-5.1 Toxicity and Quantitative and qualitative Open access peerbioactive
potential analyses of EV effects reviewed publication of EVs and of their
(including cytotoxicity and as supplementary engineered genotoxicity) on
several cell material counterparts lines (Excel and text files)

_How will the data be collected or created ?_ Various scientific methods,
protocols and instruments will be used in VES4US. Many will be based on well-
established approaches which are detailed in the scientific literature and are
already part of in-house procedures used in the laboratory of the Principal
Investigators (PIs) within the consortium. Some experiments will use
commercially available kits which are batch numbered and manufactured with
Quality Control checks. New frontier research will also be carried out in
VES4US, for which protocols have not been developed, and could be considered
further for potential licencing. A harmonised structure for data storing (file
naming, folder structure) has been agreed between the PIs. Time will be made
for reviewing periodically the consistency and quality of the data collected
(review of data or representation, adequacy of calibration, measurement
repeatability), which will be documented by the PIs, Task Leaders and Work
Package Leaders within VES4US.

_To whom might it be useful ?_ The data generated throughout the project will
be used by the consortium members and may be of interest to the European
Commission services and European Agencies, EU National Bodies, the specialist
niche and broader scientific community as well as the general public. The data
produced as part of VES4US will also be of use to a variety of industrial
actors affiliated to the therapeutic medicine, cosmetic, nutraceutic and
instrumentation manufacturing sectors.

#  DOCUMENTATION AND METADATA

_What documentation and metadata will accompany the data ?_ Rigorous data
documentation will be carried out so as to prevent misuse, misinterpretation
or confusion by secondary users and to facilitate understanding and reusing
data. This will include basic details such as:

  * who created or contributed to the data, 

  

  * data set title, 

  

  * date of creation 

  

  * conditions under which specific data can be accessed, 

  

  * Details on the methodology used, 

  

  * analytical and procedural information, 

  

  * definitions of variables, 

  

  * units of measurement, 

  

  * assumptions made, 

  

  * format and file type of the data, 

  

  * data published or not (if so, link to be added) 

  

The information will be captured at the end of planned experiments and
recorded and stored by the PIs, Task Leaders and/or Work Package Leaders.
Metadata files will be created as ‘readme’ text file to help secondary users
with data localisation and description. The use of metadata standards will be
considered based on the quality of the results; the catalogue of disciplinary
metadata standards maintained by the internationally-recognised centre of
expertise Digital Curation Centre (DCC) will be considered to this effect.

The assignment and management of persistent identifiers (PIDs) to the most
relevant data associated with EV characterisation will be assessed in the
course of the project. A naming convention has been agreed upon for metadata,
datasets and templates will consist of three parts separated by an underscore:
1) a prefix indicating whether the file is a dataset, metadata or a template,
2) a root composed of a short description of the file content and name of file
provider and 3) a suffix indicating the date of the last updated version. An
example could look like the following :

VES4US_dataset_EVdistribution_CNR_Palermo_ABed140219.

_Where will the data/metadata be located ?_ Until data sets are made available
as supplementary material in publications or a data repository centre is
chosen, all key files pertaining to data sets or publication material will be
stored in dedicated folders on the Google Drive account shared by the VES4US
consortium. Selected information will also be made publicly available on the
VES4US website when appropriate.

#  ETHICS AND LEGAL COMPLIANCE

_How will ethical issues be managed ?_ Consent or anonymisation will not be
needed as no human personal data will be used or generated. The use of human
cell lines is standard practice in many research and 3  rd  level
institutions. Moreover, the use of an invertebrate model as C. elegans has few
ethical concerns for the public and is highly supported by the E.U.
(Resolution on the protection of animals used for scientific purposes,
5/05/2009). The foreseen experiments on human cells and animals (mice and
rats) will be carried out according to the appropriate ethical requirements,
as detailed in part B (chapter 5) of the Grant agreement. As described in the
same section, all related documentation (including copies of authorisations
for the supply of animals and the animal experiments and copies of training
certificates/personnel licences of the staff involved in animal experiments)
are stored and will be provided upon request.

_How will copyright and Intellectual Property Rights issues be managed ?_ No
specific plan for licensing the data is anticipated as of now; this will be
further explored as part of the exploitation plan of VES4US (D.7.3 and D.7.7).
This might be revised depending on the results generated and discussions
amongst the VES4US consortium members. To that end, specific data sharing
might be postponed or partially restricted to protect proprietary information
should licensing or the filing of patents be considered.

#  STORAGE AND BACK UP

_How will the data be stored and backed up during the research ?_ Electronic
files will be stored on computers, external storage devices and hard drives
but, most importantly, also placed on shared drives within the host
institution networks, which are automatically backed up periodically and
reviewed by IT services staff. Specifically, a backup of the Google Drive
shared files is periodically (once a week) created on an external hard drive
by the VES4US coordinator. Hard copies of key data will also be kept within
laboratory log-books. Relevant files suitable for sharing will also be made
available via access on the Google Drive specifically set up for the project.

_How will access and security be managed ?_ No sensitive confidential data in
terms of personal information is associated with VES4US; data privacy risk is
therefore not a key issue. Basic security management will be adhered to via
the use of password-protected computers and instruments in restricted access
rooms. Key data files and folders will also be password-protected on a case-
bycase basis. Sensitive data will be identified by PIs, Task Leaders and/or
Work Package Leaders and placed in a dedicated folder on the shared Google
Drive prior to considering their suitability for patenting or publishing.

#  SELECTION AND PRESERVATION

_Which data are of long-term value and should be retained, shared, and/or
preserved ?_ No data are anticipated to be subjected to destruction for
contractual, legal or regulatory purposes. Key data generated through the Work
Packages will be selected for long-term retention. This will be informed by
the data deemed suitable for publication or which would be needed as
foundation or validation work for future spin-off experiments. It is
anticipated that data/protocols could be translated and re-used as part of
some of the teaching programmes in place in some of the partner institutions
within VES4US. All staff members involved in VES4US will be required to
prepare data and other files for sharing and preservation for facilitating
data access by secondary users.

_What is the long-term preservation plan for the dataset ?_ Some of the data
will be preserved beyond the period of funding. For example, some strains
might be deposited in international culture collections or biomass/extracts
kept in freezers for future validation by third parties. Key data sets
relevant to EV characterisation will be deposited, during year-3, for long-
term storage in repository centres so that a ‘persistent identifier’ is
associated with the data for easy discoverability; the search for the most
relevant centres will be investigated during the project (eg. Zenodo, EVpedia,
EVtrack, exocartaor vesiclepedia) using specific online tools (eg. Re3data).
Some are free or have reasonable rates, the expenses for which would be
covered by the VES4US budget. Table 3 indicates the data sets that are
anticipated to be deposited in data repository centres.

Table 3. Identification of key data sets probably suitable for deposition in
EV-related data repository centres during the final year of VES4US  
  
<table>  
<tr>  
<th>

Relevant WP + task

</th>  
<th>

Data set designation

</th>  
<th>

Type of data and data files

</th>  
<th>

Outlet and format for preservation and

sharing

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

Task-3.3

</td>  
<td>

Proteomic data for natural source EVs

</td>  
<td>

To be determined

</td>  
<td>

Open access data

repository centres

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

Task-3.4

</td>  
<td>

Lipidomic data for EVs purified from natural source

cultures

</td>  
<td>

To be determined

</td>  
<td>

Open access data

repository centres

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

#  DATA SHARING

_How will the data be shared ?_ Potential data users will be informed about
the type of data available and their location upon dissemination (peer-
reviewed publications, international conferences, national symposia) and
outreach activities (workshop, secondary school visits, social media
platforms). This information will also be present on the relevant VES4US
webpages as well as the final theses of the postgraduate students recruited,
which will be made available via inter university library loans. As per
general practice, published data will be made available within 6 months of
publication and ‘green-gold routes’ given consideration. This specific aspect
will be discussed in more depth during Steering Committee meetings. Open
Access peer reviewed manuscripts and data sets will also be uploaded onto
scientific networking platforms (e.g. ResearchGate, Zenodo) for sharing.
Requests for access to data will be handled directly during the lifetime of
the project. Thereafter, selected data files will be accessible via specific
repositories (yet to be decided upon). Conditions (eg. acknowledging the reuse
of the data) will be made onto potential users depending on the type, size,
complexity and sensitivity of the data sought. Specific data sharing might
also be postponed or partially restricted to protect proprietary information
should licensing or the filing of patents be considered.

#  RESPONSIBILITIES AND RESOURCES

_Who will be responsible for data management ?_ The implementation of the DMP
(data capture, metadata production, data quality, storage and backup, data
archiving and data sharing) will be the responsibility of the VES4US steering
committee, which will periodically review progress. All contributors to the
Tasks, Milestones and Deliverables of VES4US will help compiling data sets and
outputs and specifying the level of sharing associated with such activities.

_What resources will be required to deliver the Data Management Plan ?_
Scrutiny into the level of resources to commit towards the full implementation
of the DMP in VES4US will be reviewed during year-2 of the project, especially
when the identification of a suitable data repository centre will be
discussed.

#  CONCLUSION

VES4US is committed towards the training of a highly qualified workforce to
meet the future needs of the European society and to develop a knowledge-based
economy. Adherence to the FAIR principles of data findability, accessibility,
interoperability and reusability is seen as essential to sustain the continuum
of data generation and interpretation amongst EU-funded projects with finite
life-cycles. VES4US will hence make the data, publications and/or outcomes
generated throughout its duration (and after its completion) accessible to a
variety of relevant end-users such as European Agencies, National Bodies, the
specialist niche and broader scientific community as well as the general
public and industrial actors.