#  FAIR DATA

##  Making data findable, including provisions for metadata

Within RNADIAGON, we will standardize rules and guidelines for how laboratory
logbooks are maintained and archived at each of project partners. So far, the
practice has been diverse and quality control relied exclusively on the
responsible research group leaders. RNADIAGON will establish naming
conventions and provide resources to produce structured metadata. All datasets
produced within the project will be indexed in repositories Accession Numbers.
Metadata of the published datasets will include information include all
critical information necessary to reproduce the experiment: source and storage
of material before the experiment, experimental conditions, equipment,
controls and treatments. The data and metadata produced by core facilities do
not follow any clear standards, it is generally the responsibility of users to
identify the proper identification guidelines for their experiment.

##  Making data openly accessible

Within RNADIAGON project, raw sequencing data, pre-processed, processed data,
and metadata will be produced. These data will be openly available by
uploading to public database GEO and could be freely shared. Restrictions and
accessibility of the data could be managed by the person who uploads the data
to the database. To access to the data, Command Line Utility Tool might be
employed due to big size of raw data packages. Anyway, there is no need of
software documentation to access the data included. Regarding the type of
uploaded data, metadata will be uploaded to GEO database together with raw,
pre-processed, and processed data, concrete documentation and code will be on
request. As GEO database, a user-friendly tool, is publicly free, there are no
restrictions on use.

##  Making data interoperable

Interoparability of the data, i.e. allowing data exchange and re-use between
the cooperating institutions, organisations, and researchers, will be
guaranteed by following the manufacturer’s recommendations and depositing them
in a free GEO database with no restrictions to download and share them. To
allow inter-disciplinary interoperability, standard vocabularies for all data
types present in our data sets will be used.

##  Increase data re-use (through clarifying licences) there

Generally, we will not limit re-use by academic users by any restrictive
licences. We will follow licensing policies of public repositories used to
publish the data. Where possible, we will employ the Creative Commons CC-BY
standard, which will allow wide re-use of data while assuring proper
attribution of origin in results. We will disclose data at the time of
publishing as required by majority of journals, or only after making sure that
no potential in commercialization is endangered. The experiences of BioVendor,
Inc. (biotech industry partner) will significantly increase the competences of
academic partners to identify opportunities for transfer of knowledge and
develop strategies to valorise them (WPs 6 and 7). Thus, we will be ready to
assess the relevance of research results and data for application and proceed
towards protection of intellectual property in timely manner, making sure that
all results will be available to scientific community that may further profit
from them as soon as possible.

#  ALLOCATION OF RESOURCES

The RNADIAGON project expects to allocate financial resources to cover open
access costs of scientific publications published as a result of the project.
There is no need for additional costs regarding data management as only NGS
data (raw, pre-processed, processed, metadata) will be produced and these will
be stored in publicly available database GEO.

Ondřej Slabý as a project coordinator will be responsible for supervision and
monitoring of data policy and Data Management Plan implementation and its
regular update in cooperation with partner PIs.

The allocation of capacity to ensure that the data generated by the project
are FAIR will be the responsibility of research group leaders involved in the
project. The standard time frame for data storage is 10 years.

#  DATA SECURITY

Produced NGS data (raw, pre-processed, processed, metadata) will be safely
stored in local repositories for long term preservation. The data
infrastructure at cooperating institutions is operated by locally approved
institutes responsible for data management.

#  ETHICAL ASPECTS

RNADIAGON project does not involve direct participation of human/patients.
Peripheral blood samples to be processed in this study were anonymized
immediately after their collection and sample register at clinical centres and
all participants of RNADIAGON project will work only with fully anonymized
samples under codes. These codes do not allow to identify and trace back the
patients. All patients included in the project were informed in detail of the
specific use of their biological material; they were also informed about risks
and possible consequences associated with peripheral blood collection.
Simultaneously, the possibility to refuse to be involved in the study, or to
withdraw after the project has started on their own request without giving
reasons were highlighted to patients; this decision did not affect the care
that patient received at a hospital. Patients were also able to ask any
questions before agreeing to be involved and during the biobanking. Patient’s
handwritten signature of informed consent were required before collecting
their blood plasma/serum samples.

The RNADIAGON partners will not come into direct contact with any patients.
The RNADIAGON partners will only be working with blood/serum samples obtained
from specific biobanks. Each subject was informed about the storage of its
plasma/serum samples in biobank, the procedures, and the intended purposes,
and only after signing an informed consent, blood plasma/serum samples have
been taken. Issues on insurance, incidental findings and the consequences of
leaving the study are discussed according to the European guidelines and local
regulations. After reading and discussing the patient information sheet, all
patients recruited into the biobanks gave written informed consent.

The RNADIAGON research will not work with any personal data, including genetic
data. We will only work with fully anonymised biological samples
(serum/plasma) and with RNA which does not allow to uncover personal identity.

Only fully anonymized plasma/serum samples will be exported from EU to the
University of Texas, USA where will be used for fulfilling the project tasks.
Before an export of peripheral blood plasma/serum samples to USA, Import
Permit Approval Letter (Permit to Import Infectious Biological Agents,
Infectious Substances, and Vectors) will be obtained (also compliant with D
9.6 NEC – Requirement No. 20).

Ethical aspects related to this issue are closely descried in Description of
Action, Part B, chapter 5 and further addressed via related ethics
deliverables (D9.4 HCT – Requirement No.10, D9.5 PODP – Requirement No. 17 and
D 9.6 NEC – Requirement No. 20).