#  Summary

This document presents the data management plan for the HarmonicSS project.
More specifically, it provides the actions to be taken and the processes to be
followed for managing the data collected and generated during the project’s
lifetime. HarmonicSS brings together and will integrate datasets from _22
entities_ _across Europe and the USA_ . The datasets to be collected and
interlinked into the HarmonicSS integrated cohort are _23_ in total and come
from _11 different countries_ (being Germany, Italy, Belgium, UK, Spain,
Norway, Sweden, Greece, France, the Netherlands, USA), including pSS-related
data for more than _11680 patients (expected to reach up to 12500 patients by
the end of the project)_ .

This report covers: a) the description of the data to be collected, processed
and generated, b) the data collection procedure followed including the
methodology and standards which will be applied, c) whether data will be
shared/made open and how, d) the storage and backup processes and e) the data
curation and preservation activities. Moreover, the specific responsibilities
for the different data management activities are described and any relevant
institutional, departmental or study policies on data sharing and data
security are presented.

#  Introduction

This report describes the data management life cycle for the datasets to be
collected, analysed, processed and produced by the HarmonicSS project. It
presents how data will be handled during the project, as well as how and what
parts of the data sets will be made available following the project’s
completion.

In an overall view, Section 3 presents the HarmonicSS data, which include the
HarmonicSS Integrated Cohort and the results of the HarmonicSS scenarios. In
Section 4 the data collection process and the individual datasets to be
collected for the purposes of the HarmonicSS project are presented, with
specific details for each dataset, including the data provider, its current
purpose, the number of unique patients and records it includes, its potential
of expanding through the inclusion of new data of old patients and/or newly
generated data for new patients, among others. Section 5 presents the metadata
to be generated for the HarmonicSS data, the accompanying documentation to be
prepared and the curation processes applied. In Section 6 the storage and back
up mechanisms and operations are presented, with a particular focus on the
Cloud infrastructure set for the purposes of the HarmonicSS operations and the
data security mechanisms to be applied, based on the close interaction with
Task 4.3 “Set up of the secure cloud infrastructure, repositories and
platform”. The legal and ethical compliance of the data management operations
are described in Section 7, based on the works and results of Task 3.2
“Ethical, legal, privacy and IPR requirements for data sharing and clinical
trials” and the continuous developments of the project. Finally, Section 8
presents data preservation, sharing and access based on the combined results
of the aforementioned Tasks 3.2 and 4.3, as well as Task 2.3 “Sustainability
and expandability” and Task 5.1 “Cohort data governance and sharing services”.
“Specific responsibilities for data management” are presented in Section

9\.

It should be noted that although HarmonicSS is not part of the Open Research
Data Pilot (ORD pilot), a Data Management Plan was considered as a useful
guide for the project’s data related operations and, thus, included in the
workplan. The report has followed the “Guidelines on FAIR Data Management in
Horizon 2020” as published by the European Commission [1]. Given that most of
the related activities and tasks are ongoing and have not yet produced their
final results, the data management plan of the project may be revised in the
future.

#  The HarmonicSS Data

##  The HarmonicSS Integrated Cohort

One of the main achievements targeted at by the HarmonicSS project is to
interlink 23 highly heterogeneous local, regional, national, international and
clinical trial cohorts of patients with Primary Sjögren’s Syndrome (pSS) from
22 entities across Europe and the USA into **one Integrated Cohort** . In
these cohorts heterogeneity is met at almost all levels, posing significant
challenges towards their integration. This data include qualitative,
quantitative, clinical measurements, medical records, administrative
information, ultrasound images, biopsy results, among others. Section 4
presents the different datasets to be integrated.

The HarmonicSS Integrated Cohort is based on a highly detailed _Reference
Model_ which will be built with Semantic Web technologies based on:

  1. the analysis of the clinical partners in terms of the minimum criteria for data inclusion and quality of a cohort (Task 4.1) and 

  

  2. parameters which are met across the datasets and are not included in (a). 

  

  

The HarmonicSS Reference Model will include a wide range of well-structured
parameters, properly annotated with information about their purpose, applied
methods, value range and units, based on the results of Task 4.1 as presented
in D4.2 “Guidelines and clinical preparatory actions for completing individual
cohorts”. In order for the HarmonicSS Reference Model to be interoperable and
extendable, it will be based on and aligned with international standards and
widely used domain models, vocabularies and classifications. The list of
minimum criteria to be included in the cohort for data inclusion and quality
purposes is presented in Annex 1.

In the end, the HarmonicSS Integrated Cohort will be the outcome of the
integration of the cohorts provided by the 22 data providers of the
Consortium, which will follow international standards both in terms of
structure and values (i.e., vocabularies, classifications and coding systems).

##  Scenarios’ Results

The approaches followed and the findings from the implementation of the
HarmonicSS scenarios, including potentially new knowledge, will also be part
of the HarmonicSS data. More specifically, Table 1 presents the expected
results by each scenario-related task of the project.  
  
<table>  
<tr>  
<th>

**Scenario**

**Result**

**Dataset ID**

</th>  
<th>

**Scenario Title**

</th>  
<th>

**Expected Results**

</th>  
<th>

**Task**

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

HSS_SR_01

</td>  
<td>

Stratification model for

classifying pSS patients

</td>  
<td>

A stratification model for:

  1. the early identification of high risk individuals in clinical practice by classifying pSS patients according to laboratory predictors, biomarkers and clinical phenotypes, 

  

  2. the estimation of the risk of subsequent organ involvement and disease course and comorbidities (e.g. atherosclerosis, osteoporosis, 

  

  

</td>  
<td>

Task 6.1

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

**Scenario**

**Result**

**Dataset ID**

</td>  
<td>

**Scenario Title**

</td>  
<td>

**Expected Results**

</td>  
<td>

**Task**

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

</td>  
<td>

</td>  
<td>

psychopathological issues) in different subgroups of pSS patients and

(iii) the prescription of specific treatments to different subgroups.

</td>  
<td>

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

HSS_SR_02

</td>  
<td>

Validation of existing

biomarkers and

discovery of novel ones

</td>  
<td>

  * Validated clinical laboratory and histopathological predictors as well as autoantibodies, and genetic variants for early pSS diagnosis, lymphoma development and response to therapy. 

  

  * Novel molecular and genetic biomarkers for early pSS diagnosis using composite indices, lymphoma development and response to therapy, that can be used in the future for targeted therapies. 

  

</td>  
<td>

Task 6.2

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

HSS_SR_03

</td>  
<td>

Models of lymphomagenesis

</td>  
<td>

 A model for lymphomagenesis development in pSS patients capturing the
important and informative features that lead to lymphomagenesis.

</td>  
<td>

Task 6.3

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

HSS_SR_04

</td>  
<td>

Formulation of common clinical practices,

guidelines and rules

</td>  
<td>

  * Common European guidelines for the management of pSS patients. 

  

  * Rules for storing blood, tissue, saliva, serum, cells, DNA, RNA and biopsies samples in biobanks for pSS. 

  

</td>  
<td>

Task 6.4

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

HSS_SR_05

</td>  
<td>

pSS health policy

development

</td>  
<td>

 Preliminary estimations of the impact of a health policy through measurement
of changes in collected measures considering also the context characteristics.

</td>  
<td>

Task 8.1-8.3

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

_Table 1 The HarmonicSS Scenarios Results_

The scenarios’ results will be published at the project’s website as soon as
they are available based on the project’s timeplan (i.e. HSS_SR_01 to
HSS_SR_04 on PM36 and HSS_SR_05 on PM42) in an .xml format and annotated with
the metadata described in Section 5.

#  Data Collection

##  Description of Data to be collected

As previously mentioned, HarmonicSS brings together and will eventually
interlink datasets from _22 entities_ _across Europe and the USA_ . The
datasets to be integrated into the HarmonicSS integrated cohort, being _23_ in
total (as one partner – UPSud – will provide 2 datasets) and coming from _11
different countries_ (being Germany, Italy, Belgium, UK, Spain, Norway,
Sweden, Greece, France, the Netherlands, USA), include pSS-related data for
more than _11680 patients (expected to reach up to 12500 patients by the end
of the project)_ . In terms of content this data cover demographics,
diagnoses, results of ocular and oral tests, biopsies results, ultrasounds,
laboratory test results, clinical assessments, previous and current therapies
and genetic data. Among the datasets to be collected and integrated, 6 are
stored in an SQL database (including 1 in PostgreSQL), 1 in OpenClinica and 16
are in excel format.

The next subsections present each dataset to be collected in terms of its
current purpose, number of unique patients and records (with one patient
having one or more records), time period it covers, whether it includes
longitudinal data, the possibility to be expanded by including either new data
from old patients or data from new patients, the language the data are into,
past integration efforts, quality assurance processes applied and
pseudonymisation status. It should also be noted that each dataset is assigned
with a dataset ID in the form of HSS_CD_[NUMBERING], with HSS standing for
HarmonicSS, CD for Collected Dataset.

###  Datasets from UoA  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_01

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

**Partner Name**

</td>  
<td>

UoA

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

To systematically collect clinical and laboratory information on patients with
primary Sjogren’s syndrome and associate them with genetic, biochemical and
histopathological biomarkers.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

No

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

How **many unique patients** do your datasets involve?

</td>  
<td>

600 patients

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

How many **different records** do your datasets include?

</td>  
<td>

600 records

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

What is the **time period** the data cover?

</td>  
<td>

From 01/01/1980 to date

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Once a year

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

the HarmonicSS integrated cohort?

</td>  
<td>

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Old and new

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

300

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

Is your dataset in English?

</td>  
<td>

Yes

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

Is the dataset already pseudonymised?

</td>  
<td>

No

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 2 The UoA dataset description_

###  Datasets from AOUD  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_02

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

**Partner Name**

</td>  
<td>

AOUD

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

The Udine cohort of Sjögren’s syndrome was created in 2010 in order to collect
data, blood and tissue samples in the prospect of performing clinic research
with the main purpose of identify new biomarkers and make a stratification of
SS patients mainly according to their different risk of lymphoma development.
The nature of the cohort is local but we share our data in a large multicenter
Italian cohort of SS patients with the other Centers of the Italian Group of
Study of Sjögren’s syndrome (GRISS).

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

No

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

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

How **many unique patients** do your datasets involve?

</td>  
<td>

275 patients

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

How many **different records** do your datasets include?

</td>  
<td>

275 records

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

What is the **time period** the data cover?

</td>  
<td>

From 2010 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Every 6 months

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

to be included in the HarmonicSS integrated cohort?

</td>  
<td>

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Both

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

30-40/year

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

Is your dataset in English?

</td>  
<td>

Yes but with also Italian

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

It has been already utilized for clinical studies

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

_Table 3 The AOUD dataset description_

###  Datasets from UNIPI  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_03

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

**Partner Name**

</td>  
<td>

UNIPI

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Clinical Research

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes for specific sub-studies

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

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

How **many unique patients** do your datasets involve?

</td>  
<td>

377 patients

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

How many **different records** do your datasets include?

</td>  
<td>

377 records

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

What is the **time period** the data cover?

</td>  
<td>

From 1999 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Every 6 months

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Also new ones

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

50

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

No

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

Have you performed any quality checks on your dataset?

</td>  
<td>

No

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

_Table 4 The UNIPI dataset description_

###  Datasets from UNIPG  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_04

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

**Partner Name**

</td>  
<td>

UNIPG

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

To collect clinical and serologic data of primary Sjogren’s syndrome patients
followed in our Rheumatology Unit.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

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

How **many unique patients** do your datasets involve?

</td>  
<td>

154 patients

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

How many **different records** do your datasets include?

</td>  
<td>

154 records

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

What is the **time period** the data cover?

</td>  
<td>

From 2010 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Every 6 months

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Yes, also new ones

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

8-10 patients/year

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

No

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

Have you performed any quality checks on your dataset?

</td>  
<td>

No

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

_Table 5 The UNIPG dataset description_

###  Datasets from UNIVAQ  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_05

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

**Partner Name**

</td>  
<td>

UNIVAQ

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

  * To assess both the diagnostic and prognostic value of MSG histopatology in stratifying different clinical subsets of disease. 

  

  * To correlate the clinical, 

  

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

</td>  
<td>

serological ad immunological spectrum of pSS patients with the histological
and molecular findings in labial minor salivary glands.

 To assess efficacy and safety of Rituximab in early primary Sjögren’s
syndrome.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

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

How **many unique patients** do your datasets involve?

</td>  
<td>

111 patients

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

How many **different records** do your datasets include?

</td>  
<td>

111 records

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

What is the **time period** the data cover?

</td>  
<td>

From 2010 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

2 times/year

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Yes (old and new patients)

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

100

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

No

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

Have you performed any quality checks on your dataset?

</td>  
<td>

No

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

_Table 6 The UNIVAQ dataset description_

###  Datasets from UNIRO  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_06

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

**Partner Name**

</td>  
<td>

UNIRO

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Research purposes. Some data have been used for collaborative works (Italian
study group for SS).

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

How **many unique patients** do your datasets involve?

</td>  
<td>

514

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

How many **different records** do your datasets include?

</td>  
<td>

514

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

What is the **time period** the data cover?

</td>  
<td>

From 1995 to 2017 (actually only 1 is from 1995, the majority from 2005)

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes - histological data with evaluation of focus score, mean foci area (mm2),
% of MSG infiltration, segregated foci (yes or no), percentage of segregated
foci, presence of germinal centre (GC)(yes or no), % of GC, presence of LESA
(yes or no).

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Whenever necessary – estimated to be every 3 months

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

They will refer to all the new patients and also part of the old patients, if
biopsies are available

(till now around 50 patients)

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

At least 50 new per year

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

Is your dataset in English?

</td>  
<td>

Originally in Italian but has been translated to English

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

Is the dataset already pseudonymised?

</td>  
<td>

Not yet

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

Have you performed any quality checks on your dataset?

</td>  
<td>

No

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

_Table 7 The UNIRO dataset description_

###  Datasets from MHH  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_07

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

**Partner Name**

</td>  
<td>

MHH

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Studying associations of autoantiobodies with CTDs and clinical features of
pSS.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

No

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

How **many unique patients** do your datasets involve?

</td>  
<td>

255 patients

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

How many **different records** do your datasets include?

</td>  
<td>

2000 records

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

What is the **time period** the data cover?

</td>  
<td>

From 2012 to 2017

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

Are there any **new data,** which will be collected during the project’s

</td>  
<td>

</td>  
<td>

No

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated

</td>  
<td>

\-

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

lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

cohort?

</td>  
<td>

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

\-

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

\-

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 8 The MHH dataset description_

###  Datasets from CUMB  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_08

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

**Partner Name**

</td>  
<td>

CUMB

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Data bank to identify patients with Sjögren’s to participate in pre-clinical
and clinical studies.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

No

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Partially

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

How **many unique patients** do your datasets involve?

</td>  
<td>

~ 180 patients

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

How many **different records** do your datasets include?

</td>  
<td>

~180 records

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

What is the **time period** the data cover?

</td>  
<td>

From around 2010 onwards

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

TBD

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Both

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

TBD

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your

</td>  
<td>

Yes

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

dataset?

</td>  
<td>

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

_Table 9 The CUMB dataset description_

###  Datasets from UoB  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_09

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

**Partner Name**

</td>  
<td>

UoB

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

**Dataset Name**

</td>  
<td>

OASIS

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

(i) To develop blood, tissue and imaging biomarkers predictive of disease
activity and complications in pSS, including lymphoma development, (ii)
peripheral blood and imaging correlates of the key diagnostic and prognostic
features present in salivary gland biopsies (iii) identify risk factors for
pSS.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Not at present.

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

No

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

How **many unique patients** do your datasets involve?

</td>  
<td>

81 pSS patients meeting AECG criteria, 13 pSS not meeting AECG criteria, 9
secondary Sjögren’s and

70 sicca syndrome

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

How many **different records** do your datasets include?

</td>  
<td>

173 records

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

What is the **time period** the data cover?

</td>  
<td>

From 04/2014 to 04/2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

TBD

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

\-

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

TBD

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

\-

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

Is your dataset in English?

</td>  
<td>

Yes

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 10 The UoB dataset description_

###  Datasets from QMUL  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_10

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

**Partner Name**

</td>  
<td>

QMUL

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

**Dataset Name**

</td>  
<td>

Sjogren EMR Biobank

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Correlation of salivary gland biopsies, peripheral blood immunophenotype and
circulating inflammatory biomarkers with clinical parameters of disease
activity.

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

How **many unique patients** do your datasets involve?

</td>  
<td>

300 patients

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

How many **different records** do your datasets include?

</td>  
<td>

300 records

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

What is the **time period** the data cover?

</td>  
<td>

From 2010 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Every 6 months

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Potentially both

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

TBD

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

Is your dataset in English?

</td>  
<td>

Yes

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 11 The QMUL dataset description_

###  Datasets from UNEW  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_11

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

**Partner Name**

</td>  
<td>

UNEW

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

**Dataset Name**

</td>  
<td>

UK primary Sjogren’s syndrome registry

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

For research and it has been used to support various research projects led by
Newcastle as well as collaborators.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes (a subset)

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

No

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

How **many unique patients** do your datasets involve?

</td>  
<td>

850 patients

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

How many **different records** do your datasets include?

</td>  
<td>

1100 records

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

What is the **time period** the data cover?

</td>  
<td>

From 2009 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Annually

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Both

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

100

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

Is your dataset in English?

</td>  
<td>

Yes

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 12 The UNEW dataset description_

###  Datasets from IDIBAPS  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_12

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

**Partner Name**

</td>  
<td>

IDIBAPS

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Retrospective clinical description

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

No

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

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

How **many unique patients** do your datasets involve?

</td>  
<td>

580 patients

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

How many **different records** do your datasets include?

</td>  
<td>

580 records

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

What is the **time period** the data cover?

</td>  
<td>

From 1992 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in

</td>  
<td>

</td>  
<td>

No

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

\-

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

the HarmonicSS integrated cohort?

</td>  
<td>

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

\-

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

\-

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

No

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

_Table 13 The IDIBAPS dataset description_

###  Datasets from UBO  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_13

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

**Dataset Name**

</td>  
<td>

DIApSS cohort

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

To study the diagnostic performance of the various existing classification
criteria at inclusion, to study the diagnostic performance of new tests used
in clinical practice, such as salivary gland ultrasound or various biological
tests, new histological methods..., to evaluate during the follow-up the
evolution of the disease and the results of the different tests, to correlate
the different tests to the prognosis of the patient (5 years) and to study the
evolution of the disease activity and quality of life of the patient.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes but not for all the patients

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes (ASSESS cohort, Precisesads)

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

How **many unique patients** do your datasets involve?

</td>  
<td>

100

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

How many **different records** do your datasets include?

</td>  
<td>

100

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

What is the **time period** the data cover?

</td>  
<td>

From 2006 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in

</td>  
<td>

</td>  
<td>

No

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

\-

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

the HarmonicSS integrated cohort?

</td>  
<td>

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

\-

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

\-

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

Is your dataset in English?

</td>  
<td>

No but easy to translate

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

No

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

_Table 14 The UBO dataset description_

###  Datasets from UPSud  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_14

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

**Partner Name**

</td>  
<td>

UPSud

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

**Dataset Name**

</td>  
<td>

Paris Sud Cohort

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Our data have been used:

  * for translational studies we made 

  

  * for the establishment of new ACR/EULAR criteria of the disease. 

  

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

No

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes with the ORMF and SICCA for establishing ACR/EULAR criteria

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

How **many unique patients** do your datasets involve?

</td>  
<td>

519 patients

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

How many **different records** do your datasets include?

</td>  
<td>

519 records

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

What is the **time period** the data cover?

</td>  
<td>

From 2001 to 2016

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes, but only if lymphoma development occurs

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Every year

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Old patients

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

\-

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

When merged with the American data for providing criteria

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

_Table 15 The UPSud (Paris Sud cohort) dataset description_  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_15

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

**Partner Name**

</td>  
<td>

UPSud

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

**Dataset Name**

</td>  
<td>

ASSESS Cohort

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

French multicentre cohort

involving 15 centers

12 publications concerning this cohort

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

1 visit every year for 20 years

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

We perform common research with Fai Ng (UNEW) involving this cohort integrated
with the UK registry

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

How **many unique patients** do your datasets involve?

</td>  
<td>

395 patients

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

How many **different records** do your datasets include?

</td>  
<td>

395 records

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

What is the **time period** the data cover?

</td>  
<td>

Inclusions From 2006 to 2009

Follow-up which is on-going

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Longitudinal data every year

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Old patients

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

\-

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

At each translational study made with this cohort

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

_Table 16 The UPSud (ASSESS cohort) dataset description_

###  Datasets from UU  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_16

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

**Partner Name**

</td>  
<td>

UU

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

**Dataset Name**

</td>  
<td>

“DISSECT”; Dissecting disease mechanisms in three systemic inflammatory
autoimmune diseases with an interferon signature.

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

To investigate genetic susceptibility for pSS through targeted gene sequencing
and genome wide association analyses, to investigate genetic variants
associated with different disease phenotypes, followed by functional analyses.

Clinical data describing female/male differences is an accepted manuscript.

A subset of the data is part of the Sjögren’s syndrome genetics network
“SGENE” collaboration with Kathy Sivils, USA.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

No

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

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

How **many unique patients** do your datasets involve?

</td>  
<td>

983 patients

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

How many **different records** do your datasets include?

</td>  
<td>

983 records

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

What is the **time period** the data cover?

</td>  
<td>

From 1956 (first year recorded as symptom onset) to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Once a year

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Mostly new patients

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

25 per year

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

Is your dataset in English?

</td>  
<td>

Yes

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 17 The UU dataset description_

###  Datasets from UMCG  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_17

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

**Partner Name**

</td>  
<td>

UMCG

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

**Dataset Name**

</td>  
<td>

RESULT cohort

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Primary: To identify biomarkers and clinical parameters that determine and
predict the longitudinal course of pSS, taking into account patient-reported,
functional, imaging, histopathological, laboratory and genetic data.

Secondary: A) To identify biomarkers and parameters that determine and predict
the progression from early pSS to established pSS. B) To evaluate the effect
of treatment of pSS in routine clinical practice and to identify predictors of
response to treatment. C) To assess the diagnostic ability of salivary gland
ultrasound in pSS and its applicability in monitoring disease activity and
progression.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

No

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

How **many unique patients** do your datasets involve?

</td>  
<td>

Current inclusion: 120 patients

Expected inclusion (total): 500 patients

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

How many **different records** do your datasets include?

</td>  
<td>

Per patient: max. 793 variables

Currently: 1-3 time points

Expected (total): max. 26 time points

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

What is the **time period** the data cover?

</td>  
<td>

Inclusion: January 2016 to

December 2020

Follow-up: until December 2030

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Up to 26 times per patient

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Current inclusion: 120 patients

Expected inclusion (total): 500 patients

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

Expected inclusion (total): 500 patients

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 18 The UMCG dataset description_

###  Datasets from UMCU  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_18

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

**Partner Name**

</td>  
<td>

UMCU

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

**Dataset Name**

</td>  
<td>

UMCU cohort, U-systems cohort

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Clinical and fundamental research - to find determinants of disease severity
in pSS.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes, partly

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

(big data cohort, Ramos Casals et al)

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

How **many unique patients** do your datasets involve?

</td>  
<td>

378 patients

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

How many **different records** do your datasets include?

</td>  
<td>

783 records

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

What is the **time period** the data cover?

</td>  
<td>

From 1996 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

40 pSS patients/year

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

New ones

And Follow up (old)

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

</td>  
<td>

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

20 pSS patients/year

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

Is your dataset in English?

</td>  
<td>

Yes

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 19 The UMCU dataset description_

###  Datasets from NIVEL  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_19

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

**Partner Name**

</td>  
<td>

NIVEL

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

**Dataset Name**

</td>  
<td>

NIVEL Primary Care Database

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Provide nationally representative information on developments in population
health and health service utilisation and the quality of primary care. Our
data has been used for several hundreds of research projects for secondary
analyses.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

No

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

How **many unique patients** do your datasets involve?

</td>  
<td>

~ 3000

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

How many **different records** do your datasets include?

</td>  
<td>

~ 3000

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

What is the **time period** the data cover?

</td>  
<td>

We have longitudinal data on this scale since 2010.

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

No

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

\-

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

\-

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

\-

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 20 The NIVEL dataset description_

###  Datasets from UiB  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_20

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

**Partner Name**

</td>  
<td>

UiB

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

Quality Register for the Department of Rheumatology and Research Group

Immunology/Rheumatology.

Substrate for further analysis/research during the last 20 years.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

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

How **many unique patients** do your datasets involve?

</td>  
<td>

200 patients within 2 years

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

How many **different records** do your datasets include?

</td>  
<td>

200 records

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

What is the **time period** the data cover?

</td>  
<td>

01.04.2017 – on going

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

TBD

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

\-

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

If yes, data on old patients will be updated and new patients included.

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

40 new patients within the end of

2017

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

Is your dataset in English?

</td>  
<td>

No

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

Is the dataset already pseudonymised?

</td>  
<td>

No

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

Have you performed any quality checks on your dataset?

</td>  
<td>

No

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

_Table 21 The UiB dataset description_

###  Datasets from ULB  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_21

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

**Partner Name**

</td>  
<td>

ULB

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

The cohort of patients suffering from Sjögren’s syndrome was created to
collect data, blood and tissue samples in the prospect of performing
translational research aiming at deciphering the pathogenesis of the disease
and identifying new diagnostic biomarkers.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

No

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

How **many unique patients** do your datasets involve?

</td>  
<td>

210 patients

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

How many **different records** do your datasets include?

</td>  
<td>

210 records

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

What is the **time period** the data cover?

</td>  
<td>

From 2008 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

2 times per year

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Yes

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

TBD

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

Is your dataset in English?

</td>  
<td>

No (could be changed to English)

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

No

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

_Table 22 The ULB dataset description_

###  Datasets from OMRF  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_22

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

**Partner Name**

</td>  
<td>

OMRF

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

This resource supports numerous clinical studies for OMRF investigators and
outside collaborators. Studies include gene mapping, transcriptional

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

</td>  
<td>

profiling, clinical characterizations and immunological studies.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

No

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

No

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

How **many unique patients** do your datasets involve?

</td>  
<td>

1310 patients

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

How many **different records** do your datasets include?

</td>  
<td>

1310 records

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

What is the **time period** the data cover?

</td>  
<td>

From Jan 2008- to Dec 2016

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

No

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

\-

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

\-

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

\-

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

Is your dataset in English?

</td>  
<td>

Yes

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

Is the dataset already pseudonymised?

</td>  
<td>

Yes

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 23 The OMRF dataset description_

###  Datasets from HAROKOPIO  
  
<table>  
<tr>  
<th>

**Dataset ID**

</th>  
<th>

HSS_CD_23

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

**Partner Name**

</td>  
<td>

HAROKOPIO

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

What is the current **purpose** of your data? How has it been **used** so far?

</td>  
<td>

The cohort of patients with Sjogren's syndrome includes sequential clinical
and laboratory data as well as tissue samples obtained for diagnostic as well
as research purpose. Part of the data and tissues from this cohort has been
used in previous clinical and translational research.

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

Does your cohort involve **longitudinal** data?

</td>  
<td>

Yes

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

Have you ever integrated your cohort with other cohorts in the past?

</td>  
<td>

Yes

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

How **many unique patients** do your datasets involve?

</td>  
<td>

100 patients

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

How many **different records** do your datasets include?

</td>  
<td>

200 records

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

What is the **time period** the data cover?

</td>  
<td>

From 1985 to 2017

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

Are there any **new data,** which will be collected during the project’s
lifetime, expected to be included in the HarmonicSS integrated cohort?

</td>  
<td>

</td>  
<td>

Yes

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

If yes, how **frequently** do you expect to provide **new** data to the
HarmonicSS integrated cohort?

</td>  
<td>

Every six months

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

If yes, do the new data refer to **old** patients or also **new** ones?

</td>  
<td>

Both old and new

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

If planning to include new patients, could you provide an estimation for their
number?

</td>  
<td>

10

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

Is your dataset in English?

</td>  
<td>

Yes

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

Is the dataset already pseudonymised?

</td>  
<td>

No

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

Have you performed any quality checks on your dataset?

</td>  
<td>

Yes

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

_Table 24 The HAROKOPIO dataset description_

##  Methodology for Data Collection

The methodology utilised for the data collection process in the HarmonicSS
project towards their successful integration into the HarmonicSS integrated
cohort is described in the next paragraphs. Given that the HarmonicSS
Scenarios’ results constitute data being the output of the project’s
scenarios, the data collection processes focus on the HarmonicSS Integrated
Cohort.

The HarmonicSS Integrated Cohort will include three different sets of data;

  1. retrospective data, i.e., data already collected by patients from the clinical partners serving as data providers, 

  

  2. new data from old patients of the clinical partners in the form of follow up visits, and (c) new data from new patients of the clinical partners (i.e., patients for whom no data has been collected and thus provided as part of the retrospective data) each of which may require different handling in legal, ethical and technical terms. Nevertheless, the initial steps of the data collection process are common across all different sets of data and are described in the following paragraphs. 

  

  

As a first step and for the technical partners to make a first assessment of
the datasets variability and required workload for analysis, high-level
descriptive information of each dataset was collected from the data providers
by means of an excel file. The requested information was in regard to:

  * the data storage type used (db, file incl. format, legacy system, EHR, etc.), 

  

  * the international or local vocabularies used (whether or not they are used, which ones are used, in case of local repositories whether there is a mapping to international ones), 

  

  * the total number of records, 

  

  * the frequency of updates and 

  

  * the number of unique patients. 

  

For the sake of effective data collection and analysis, each technical partner
participating in the analysis and integration activities of the HarmonicSS
cohorts was allocated with a number of datasets (in line with their assigned
effort), which is presented in Table 25.  
  
<table>  
<tr>  
<th>

**Technical Partner**

</th>  
<th>

**Dataset ID**

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

**ICCS/NTUA**

</td>  
<td>

HSS_CD_01

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

HSS_CD_03

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

HSS_CD_06

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

HSS_CD_10

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

HSS_CD_16

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

HSS_CD_20

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

HSS_CD_23

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

**UOI**

</td>  
<td>

HSS_CD_13

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

HSS_CD_18

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

HSS_CD_19

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

HSS_CD_21

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

**ATOS**

</td>  
<td>

HSS_CD_05

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

HSS_CD_11

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

HSS_CD_12

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

HSS_CD_14

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

HSS_CD_15

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

HSS_CD_17

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

**BIOIRC**

</td>  
<td>

HSS_CD_02

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

HSS_CD_08

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

**CERTH**

</td>  
<td>

HSS_CD_04

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

HSS_CD_07

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

HSS_CD_09

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

**TEIC**

</td>  
<td>

HSS_CD_22

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

_Table 25 Assignment of Dataset to Technical Partners_

_All subsequent actions, interactions and communications_ pertaining to the
collection of additional information, the analysis and in depth knowledge
acquisition of the dataset fields, is to be carried out among the
predetermined technical partner and dataset provider pairs. The technical
partners are organized by the WP leader in collaboration with the technical
coordinator. Regular meetings (online and/or physical) are set up in order to
organize the team, observe the status of work, identify any open issues and
risks, and promptly come up with solutions. Any serious problems related to
the cooperation with the data providers (e.g., lack of response or feedback)
is to be ultimately communicated to the scientific coordinator and project
coordinator so that the appropriate actions are performed for the issues to be
promptly resolved.

As a next interaction step, the WP leader created a set of templates for the
elicitation of more detailed information on the datasets. The table (as
presented in Section 4.1) provides information on current data purpose and
present usage, number of unique patients, number of different records, time
period that the data covers, details regarding new data to be collected during
the project’s lifetime, language of dataset, pseudonymisation status, quality
checks, etc.

The data providers were further asked to provide the exact structure of their
dataset, including all of its fields, and a data sample, which should reflect
a pseudonymised record of real patient data. These data were initially
analysed by the technical partners in terms of:

  * overall structure and individual parameters 

  

  * meaning of fields 

  

  * expected field values 

  

  * vocabularies, coding systems, classifications for specific fields, such as diagnosis, treatments, demographics (e.g., gender, ethnicity, etc.) 

  

The analysis is enriched through iterative collaborative interaction between
the individual technical and data provider pairs. The objective is to clearly
capture the meaning of each parameter in each dataset and obtain the level of
detail necessary for their prospective alignment. Towards this direction,
cardinality restrictions, thresholds and assumptions or methodology used for
defining the field value, relation among fields, are topics of discussion
within each pair.

In order to facilitate information and data sharing among the technical
partners, a collaborative file sharing repository is being utilized. A
separate folder was created for each of the 22 data providers, and was named
using the scheme [ _NR].[PARTNER_SHORT_NAME]_ with NR standing for the
partners’ number in the project Consortium. Partners work on an offline copy
of their files and regularly update them in the repository, whenever they
consider that substantial changes have been made or an internally set deadline
or milestone approaches. Versioning is taken care of by means of including the
date of last update at the beginning of each filename, in the format _YYMMDD_
\- Year, Month, Day. It should be noted that this repository is used
exclusively for the structure analysis and by no means is any patient data
uploaded and/or shared through this repository.

The collection of clinical data is carried out in accordance with the legal
requirements established in D3.2 "Ethical, legal, privacy and IPR requirements
for data sharing and clinical trials” and Ethics Requirements established in
WP9 “Ethics Requirements”.

Accordingly:

  1. retrospective data is collected by the project subject to: the receipt of written approval by the Ethics Committee, pseudonymisation and other conditions set by D.3.2, Section 4.7, Table 3, if applicable; 

  

  2. follow-up data of old patients is collected subject to Ethics Approval, pseudonymisation, informed consent of the patient for research covering HarmonicSS (either in the form provided in D.3.2, Annex 4, or in the form used by the data provider, but satisfying the scope of research in HarmonicSS), other conditions set by D.3.2, Section 4.7, Table 3, if applicable; 

  

  3. newly collected data from new patients is collected subject to: Ethics Approval, pseudonymisation, informed consent of the patient for research covering HarmonicSS (either in the form provided in D.3.2, Annex 4, or in the form used by the data provider, but satisfying the scope of research in HarmonicSS), other conditions set by D.3.2, Section 4.7, Table 3, if applicable. 

  

  

All data providers shall provide already pseudonymised data. Each technical
partner will then harmonize explicitly the datasets they are assigned with by
linking them with the HarmonicSS Reference Model, in terms of structure and
vocabularies.

It should be noted that as soon as the HarmonicSS Reference Model is built and
validated, the new data (either follow-up data of old patients or newly
collected data from new patients) will be collected based on this model, and,
hence, this data will be harmonized with the HarmonicSS Integrated Cohort.

Regarding data quality assurance, and completeness in particular, Task 4.1
“Guidelines and clinical preparatory actions for completing individual
cohorts” of the HarmonicSS workplan is specifically dedicated to ensuring the
data quality of the provided datasets, setting the clinical preparatory
actions required for filling in any missing data within their datasets based
on a minimum set of parameters. Work within this task involves the completion
of any missing data from the retrospective data, whereas any new data
collected during the project’s activities are expected to follow the
guidelines set out within Task 4.1 and, thus, be complete.

#  Documentation, metadata and curation

The HarmonicSS Integrated Cohort will be accompanied by the detailed
description of the Reference Model, which will be the basis for its
development. This description will include the different parameters of the
model along with their value range, vocabularies and classifications used as
well as their semantic relationships. Moreover, each parameter will be
followed by a clear description of its meaning and purpose as well as any
important information required for its understanding and unambiguous use, such
as method applied (if applicable).

Furthermore, the HarmonicSS Integrated Cohort will be described through
metadata which will are presented in Table 26:  
  
<table>  
<tr>  
<th>

**Metadata Element**

</th>  
<th>

**Sub-element**

</th>  
<th>

**Sub-element**

</th>  
<th>

**Description**

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

Creator(s)

</td>  
<td>

Name

</td>  
<td>

</td>  
<td>

The name of the dataset creator

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

Affiliation

</td>  
<td>

</td>  
<td>

The affiliation of the dataset creator

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

Date of Creation

</td>  
<td>

</td>  
<td>

</td>  
<td>

The date that the dataset was built

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

Data collection period

</td>  
<td>

From

</td>  
<td>

</td>  
<td>

The first chronologically date of any record within the dataset

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

To

</td>  
<td>

</td>  
<td>

The latest chronologically date of any record within the dataset

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

Format

</td>  
<td>

</td>  
<td>

</td>  
<td>

The format of the dataset (e.g., xml, SQL, RDF)

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

Conditions of data use

</td>  
<td>

Who

</td>  
<td>

Username

</td>  
<td>

A user who can use the dataset under the specific conditions set in this
element.

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

Role

</td>  
<td>

A role who can use the dataset under the specific conditions set in this
element.

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

Time Period

</td>  
<td>

From

</td>  
<td>

Starting date of conditions applied

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

To

</td>  
<td>

End date of conditions applied

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

Actions Allowed

</td>  
<td>

</td>  
<td>

The actions which are set under this specific condition.

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

Other Terms

</td>  
<td>

</td>  
<td>

Other terms related to this condition of data use.

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

Related Publications

</td>  
<td>

Author

</td>  
<td>

</td>  
<td>

The name of the publication author

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

Affiliation

</td>  
<td>

</td>  
<td>

The affiliation of the publication author

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

Publication Title

</td>  
<td>

</td>  
<td>

The title of the publication

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

Editor

</td>  
<td>

</td>  
<td>

The editor of the publication

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

Link to Publication

</td>  
<td>

</td>  
<td>

The website link at which the publication is published.

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

_Table 26 Integrated Cohort Metadata_

_Additional metadata capturing the value of the integrated cohort_ will
include the following combined fields as presented in Table 27.  
  
<table>  
<tr>  
<th>

**Metadata Element**

</th>  
<th>

**Sub-element**

</th>  
<th>

**Sub-element**

</th>  
<th>

**Description**

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

Data User

</td>  
<td>

Name

</td>  
<td>

</td>  
<td>

The name of the individual having used the data.

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

Affiliation

</td>  
<td>

</td>  
<td>

The affiliation of the individual having used the data.

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

Goal(s) of Data Use

</td>  
<td>

</td>  
<td>

</td>  
<td>

The list of goals aimed at from the data use.

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

Way of Data Use

</td>  
<td>

Step ID

</td>  
<td>

</td>  
<td>

The ID of the step for capturing the order of the actions taken.

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

Service Name

</td>  
<td>

</td>  
<td>

The list of HarmonicSS services applied on the data for achieving the
aforementioned goals.

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

Input (optional)

</td>  
<td>

</td>  
<td>

The input to the aforementioned service

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

Output

(optional)

</td>  
<td>

</td>  
<td>

The output of the aforementioned service

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

Data Use Result

</td>  
<td>

</td>  
<td>

</td>  
<td>

The result of the data use

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

Link to Result

</td>  
<td>

</td>  
<td>

</td>  
<td>

The link to the website with the details of the result (e.g., a publication),
if available

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

_Table 27 Additional Metadata for Integrated Cohort_

Furthermore, metadata will also accompany each individual dataset being part
of the integrated cohort as depicted in the Table 28:  
  
<table>  
<tr>  
<th>

**Metadata Element**

</th>  
<th>

**Sub-element**

</th>  
<th>

**Sub-element**

</th>  
<th>

**Description**

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

Dataset ID

</td>  
<td>

</td>  
<td>

</td>  
<td>

A unique identifier of the dataset (see also the respective field in section
4.1 tables)

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

Creator(s)

</td>  
<td>

Name

</td>  
<td>

</td>  
<td>

The name of the dataset creator

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

Affiliation

</td>  
<td>

</td>  
<td>

The affiliation of the dataset creator

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

Date of Creation

</td>  
<td>

</td>  
<td>

</td>  
<td>

The date that the dataset was built

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

Latest Update Date

</td>  
<td>

</td>  
<td>

</td>  
<td>

The date that the dataset was latest updated

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

Data collection period

</td>  
<td>

From

</td>  
<td>

</td>  
<td>

The first chronologically date of any record within the dataset

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

To

</td>  
<td>

</td>  
<td>

The latest chronologically date of any record within the dataset

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

Format

</td>  
<td>

</td>  
<td>

</td>  
<td>

The format of the dataset (e.g., xml, SQL, RDF)

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

Conditions of dataset use

</td>  
<td>

Who

</td>  
<td>

Username

</td>  
<td>

A user who can use the dataset under the specific conditions set in this
element.

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

Role

</td>  
<td>

A role who can use the dataset under the specific conditions set

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

**Metadata Element**

</td>  
<td>

**Sub-element**

</td>  
<td>

**Sub-element**

</td>  
<td>

**Description**

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

</td>  
<td>

</td>  
<td>

</td>  
<td>

in this element.

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

Time Period

</td>  
<td>

From

</td>  
<td>

Starting date of conditions applied

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

To

</td>  
<td>

End date of conditions applied

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

Actions Allowed

</td>  
<td>

</td>  
<td>

The actions which are set under this specific condition.

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

Other Terms

</td>  
<td>

</td>  
<td>

Other terms related to this condition of dataset use.

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

_Table 28 Individual Datasets’ Metadata_

In order to clearly present the value and potential of the HarmonicSS
Integrated Cohort, the documentation will also include **best practices based
on the Scenario’s Implementation and Results** , which will be structured as
follows:

Scenario title, Scenario goal(s), Scenario Implementation (flow of services
used), Scenario Result(s), Scenario Implementer(s).

In fact, these fields, along with parameters such as Scenario Implementation
Period, Scenario ID, will also serve as metadata for the scenarios’ results,
as presented in Table 29.  
  
<table>  
<tr>  
<th>

**Metadata Element**

</th>  
<th>

**Sub-element**

</th>  
<th>

**Sub-element**

</th>  
<th>

**Description**

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

Scenario ID

</td>  
<td>

</td>  
<td>

</td>  
<td>

A unique identifier of the scenario

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

Scenario Implementer(s)

</td>  
<td>

Name

</td>  
<td>

</td>  
<td>

The name of the scenario implementer

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

Affiliation

</td>  
<td>

</td>  
<td>

The affiliation of the scenario implementer

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

Scenario

Implementation Period

</td>  
<td>

From

</td>  
<td>

</td>  
<td>

The start date of the scenario implementation

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

To

</td>  
<td>

</td>  
<td>

The end date of the scenario implementation

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

Scenario’s Goals

</td>  
<td>

</td>  
<td>

</td>  
<td>

The list of goals aimed at from the scenario implementation.

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

Scenario Implementation

</td>  
<td>

Step ID

</td>  
<td>

</td>  
<td>

The ID of the step for capturing the order of the actions taken.

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

Service Name

</td>  
<td>

</td>  
<td>

The list of HarmonicSS services used for achieving the aforementioned goals.

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

Input (optional)

</td>  
<td>

</td>  
<td>

The input to the aforementioned service

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

Output (optional)

</td>  
<td>

</td>  
<td>

The output of the aforementioned service.

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

Scenario Result

</td>  
<td>

</td>  
<td>

</td>  
<td>

The result of the scenario.

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

Link to Result

</td>  
<td>

</td>  
<td>

</td>  
<td>

The link to the website with the details of the result (e.g., a publication),
if available.

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

Conditions of scenario’ s results use

</td>  
<td>

Who (optional)

</td>  
<td>

Username

</td>  
<td>

A user who can use the dataset under the specific conditions set in this
element.

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

**Metadata Element**

</td>  
<td>

**Sub-element**

</td>  
<td>

**Sub-element**

</td>  
<td>

**Description**

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

</td>  
<td>

</td>  
<td>

Role

</td>  
<td>

A role who can use the dataset under the specific conditions set in this
element.

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

Time Period (optional)

</td>  
<td>

From

</td>  
<td>

Starting date of conditions applied

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

To

</td>  
<td>

End date of conditions applied

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

Actions Allowed

</td>  
<td>

</td>  
<td>

The actions which are set under this specific condition.

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

Acknowledgement

</td>  
<td>

</td>  
<td>

The text that should be included for acknowledging use of the scenario’s
results.

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

Other Terms

</td>  
<td>

</td>  
<td>

Other terms related to this condition of dataset use.

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

_Table 29 Scenarios’ Results Metadata_

This documentation, including the metadata of the Integrated Cohort, will be
available at the project’s website as soon as it will be prepared and
finalized.

Most of the data to be integrated have undergone quality checks at the data
providers’ site. Moreover, each data provider should ensure that their data is
accurate, correct and up-todate (see D9.3). Nevertheless, further quality
checks and curation processes are performed within Task 4.1 “Guidelines and
clinical preparatory actions for completing individual cohorts”. Work within
the latter task focuses on setting the clinical preparatory actions required
for data curation purposes in an effort to ensure that all datasets integrated
are complete and valid, among others. In fact, this work will also feed Task
5.1 “Cohort Data Governance and Sharing Services” in order for the latter to
build a set of methodologies, tools and key performance indicators (KPIs) for
evaluating the data sources to be part of the HarmonicSS Integrated Cohort in
terms of usability, data quality, context and purpose, among others, with the
coordination steering committee closely monitoring the process.

#  Storage and Back up

All data will be stored in the storage devices of the Okeanos private cloud
[1]. Okeanos is an IaaS (Infrastructure as a Service) located in Athens Greece
and operated from the Greek Network for Research and Technology (GRNET). Using
IaaS you can build your own computers or computer network, always connected to
the Internet, without worrying about hardware failures, spaghetti cables,
connectivity hiccups and software troubles.

The overall storage allocation including RAM and CPUs as currently allocated
in the Okeanos cloud are depicted in Figure 1.

_Figure 1 The overall storage allocation including RAM and CPUs in the Okeanos
cloud_

A storage disk of 4TeraByte is allocated for the harmonized data processing.
File storage space is a common cloud storage for data sharing between team
members that will be upgraded to 200GB (it is similar to Google Drive but for
the Okeanos case). The storage is aligned in two main categories that are a)
storage per Virtual Machine (VM) and b) global storage shared by all VMs so
that only authorized users can access the shared data. The

Okeanos cloud is based on the “synnefo” cloud framework

(https://www.synnefo.org/about/) which is an open source cloud stack that
provides services similar to Amazon Web Services (AWS). Regarding storage and
backup manipulation, for the HarmonicSS private cloud the “snf-image-creator”
family of tools is used to manipulate storage backups in holistic approach of
all VMs. With “snf-imagecreator” the total VMs of the HarmonicSS project are
backed-up and most important can be preserved or transferred to any cloud
infrastructure as VDI (VirtualBox), VHD (Microsoft Hyper-V), VMDK (VMWare),
RAWS disk format and other VM-specific image formats are supported. According
to the documentation of the “snf-image-creator” the host system itself can be
imaged while sensitive user data (user accounts, ssh keys, log files, etx)
located in the Operating System of the corresponding VM can be excluded from
the image creation. The created images can be uploaded to the overall cloud
infrastructure as private images (not visible from other cloud users) using
the “kamaki” Application Programming Interface (API) which is a tool for
managing OpenStack clouds. The “snf-image-creator” supports any Linux
distribution and can be installed even from source code by using the Python 2
framework. It is used as a command line tool or with a graphical interface,
but the command line tool is preferred. The valuable information that are
required for storage backup of any VM are:

  1. The cloud account for uploading and registering the VM image 

  

  2. The short name that identifies the image 

  

  3. A short description of the image 

  

  4. The registration type that can be private or public (private is the default). 

  

  

The cloud account for uploading and registering any backup storage image is
composed of an authentication URL combined with a secure TOKEN. Both URL and
TOKEN are securely visible only to HarmonicSS Cloud Admin. A typical usage
case for creating an operational image of a VM is created as following:

**snf-mkimage / -a https://accounts.okeanos.grnet.gr/identity/v2.0/ -t**

**53CUR3_T0K34 --tmpdir /largeTMP --no-sysprep -o ubuntuVMHarmonicss1.raw**

The “snf-image-creator” tool is used next for uploading the backed-up VM image
to the private global storage of the “Pithos” environment that is allocated
for the HarmonicSS project; Pithos is the Virtual Storage service of okeanos.
Pithos enables users to store their files online and access them anytime, from
anywhere even from the VMs. A screenshot of the “snf-image-creator” for
uploading a newly created backed-up image to the cloud storage is depicted in
Figure 2:

_Figure 2 A screenshot of the “snf-image-creator” for uploading a newly
created backed-up image to the cloud storage_

Any backup VM images can be also downloaded and secured by the cloud
management team of the project and most important can be imported in any other
cloud infrastructure in case such action is required.

In case critical data are imported to the system, immediate backups will be
performed. In case a physical device is damaged it will be replaced and full
recovery of data will be performed from the most recent backup (kept outside
of Okeanos private cloud). In terms of access management and security, direct
access to the data is not allowed for anyone. All data storage devices are
behind an OpenVPN [3] server. Public access and public IP address to the data
servers is prohibited. Consortium members that are connected through the
OpenVPN server, can access their own custom data (internal data required by
the developed systems, data models produced by intermediate processing, local
databases and reference data) through secure REST services so that they can
handle (read, update) the harmonized storage. Services for data deletion in
the global harmonized data storage are not allowed. Any Consortium member
(partner of the project) even connected with OpenVPN will not be able to
access the data server of the global datasets: a) no permission will be
granted and b) no user level access to the Virtual Machine of the data server
will be provided. Inside the Virtual Private Network only secure REST services
will be developed with the appropriate user grants to allow creation, viewing
and updating of data. The REST services will operate only through the OpenVPN
network and no GET services will be developed; thus disabling a possible
inference attack even inside the VPN by a Consortium member. The REST services
will be accessible by the collaborators using SSL/TLS transport protocol and
OAUTH2 [4] access tokens will enhance the secure service requests inside the
VPN. Finally, data will be kept pseudonymized by using a strong HASH
algorithm, meaning that according to current known technologies the user
identifiers will not be possible to be reversed (or decrypted as such a
process is not feasible when a hashing algorithm is used). Hence, minimum to
zero data security risks are foreseen. In fact, the use of private OpenVPN
connections behind firewall and disabling public access to the data servers
will ensure controlled access for data security purposes.

In terms of standards the consortium of the HarmonicSS projects utilizes the
following security standards and services in the Okeanos infrastructure:
SSL/TLS, OpenVPN, OAUTH2 authentication, HASH algorithms to encrypt patient
identifiers, thus making data almost anonymized for the developer teams using
the Okeanos cloud.

#  Ethics and Legal Compliance

The HarmonicSS project makes its best efforts to ensure that all data related
processes, from collection and sharing to data research and sustainability
shall take place in compliance with the legal requirements established by GDPR
(General Data Protection Regulation).

##  Data Protection

The ethical, data protection and IPR issues surrounding the data research in
HarmonicSS are extensively analysed in D.3.2 _Ethical, legal, privacy and IPR
requirements for data sharing and clinical trials_ (M6). In particular, the
legal requirements for data sharing (i.e. informed consent and/or Ethics
Approval (Section 4.7), the data de-identification measures (pseudonymisation
vs anonymization) (Section 4.4.4), the security obligations on part of
platform administrator and processing partners (Section 5) as well as the IPR
and ownership issues (Section 6) are covered in D3.2. Compliance with the
ethics requirements is to be ensured by WP9, which i.a. proves that data is
collected and used for HarmonicSS only after the receipt of written approval
by the Ethics Committees (D. 9.2; D.9.4); that data protection officers and/or
authorities are duly involved (D.9.4).

The contractual framework, consisting of Data Protection Memorandum of
Understanding (DP MoU) and IPR Memorandum of Understanding (IPR MOU) is
proposed for the project with the aim: (a) to clarify the data protection
roles and responsibilities of the project parties and (b) to set up
contractual mechanism for managing IPR in collaborative project results, i.a.
integrative platform and pSS cohort. The DP MoU and IPR MoU are attached to
D.3.2 as Annex 1 and 2, respectively. The conclusion of legal agreements is
planned to be finalized in line with Task 4.4 “Harmonization and individual
cohorts integration”, i.e. by M26.

Regarding data privacy and security by pseudonymisation, the two options,
namely: anonymisation and pseudonymisation, were evaluated. With regard to the
safeguards for research, Article 89 (1) GDPR advocates research on anonymous
data “ _where the research can be fulfilled by further processing which does
not permit or no longer permits the identification of data subjects_ ”;
however, the GDPR allows pseudonymisation, if anonymization would render the
fulfilment of research goals impossible. The HarmonicSS Consortium decided to
apply pseudonymisation for two main reasons: (a) among the HarmonicSS tools
there is the “Patient selection tool for multinational clinical trials” (Task
7.1) which aims at offering a mechanism for facilitating patient recruitment
for clinical trials by applying the respective eligibility criteria onto the
HarmonicSS Integrated Cohort and (b) the management of incidental findings,
dictated by the ethics of clinical research, also operates on the possibility
of linking any research findings back to the individuals. Single key vs
double-key pseudonymisation and workload associated with double-key
pseudonymisation has also been described and analysed in D.3.2, Section 4.4.4.

As already mentioned in Section 6, all data will be stored in the storage
devices of the Okeanos private cloud. UoI has already encrypted all
communication to the aforementioned infrastructure ensuring that only the
technical partners and data researchers (acting as data processors) are able
to access the technical Cloud resources. Each data processor can access only
their own Virtual Machine in the Cloud infrastructure in order to perform
strictly their own individual tasks as assigned in the HarmonicSS project
workplan. Any data access will only be available on the pseudonymised data
through the necessary security mechanisms, including secure REST services in
the Virtual Private Network (VPN) of the Cloud infrastructure. No public
access to the Virtual Machines (VMs) will be allowed, while the clinical
partners will be able to connect to the HarmonicSS user services only to
specifically dedicated Virtual Machines. The tools and services which will be
developed within the Cloud infrastructure will prohibit any direct access to
the HarmonicSS Integrated Cohort, while no delete operation will be available.
Public IP addresses will be disabled to the development of the VMs, a
limitation which will ensure that no unauthorized transmission or data breach
in any HarmonicSS data storage will be performed.

###  Data protection by default

Data protection by default is applied to HarmonicSS project from the very
beginning to provide extended safeguards related with the protection of
personal data. By taking into account the nature, scope and context of
processing, the data controller is implementing data protection by design
including the purposes of processing regarding also potential risks that can
affect the rights and freedoms of patients that are participating in the
processing. All principles of article 5 of the GDPR are taken into account for
the data protection by design. Security requirements of data are presented in
section 6 while the rights of data subjects are protected with technical
processing security measures as described in Article 32 of the GDPR. To
support the data protection by design and by default in the HarmonicSS project
the following table is presented.  
  
<table>  
<tr>  
<th>

**GDPR - Article 25 Obligations**

</th>  
<th>

</th>  
<th>

**Data Phases**

</th>  
<th>

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

**Collection**

**(M1-M42)**

</th>  
<th>

**Processing (M15-M42)**

</th>  
<th>

**Harmonization (M15-M42)**

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

“the controller shall, both at the time of the determination of the means for
processing and at the time of the processing itself, implement appropriate
technical and organisational measures, such as **pseudonymisation** , which
are designed **to implement dataprotection principles, such as data
minimisation** , in an effective manner and to integrate the necessary
safeguards into the processing in order to meet the requirements of this
Regulation and protect the rights of data subjects.”

</td>  
<td>

Article 5 obligations

including

consent forms

&

Protection of

Personal Rights

</td>  
<td>

Pseudonymization

&

Data

Minimization

</td>  
<td>

Pseudonymization

&

Data

Minimization

&

Data Retention

Policy

&

Safeguards of

Human Rights

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

“The controller shall implement appropriate technical and organisational
measures for ensuring that, **by default** , only personal data which are
necessary for each specific purpose of the processing are processed. That
obligation applies to the amount of personal data collected, the extent of
their processing, the period of their storage and their accessibility.”

</td>  
<td>

Amount of

Personal

Data=~14180 records

&

Extend of

Processing=28 months

&

Period of

Storage=28 months  1

</td>  
<td>

Amount of

Personal

Data=~14180 records

&

Extend of

Processing=28 months

&

Period of

Storage=28 months

</td>  
<td>

Amount of

Personal

Data=~14180 records

&

Extend of

Processing=28 months

&

Period of

Storage=28 months

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

“In particular, such measures shall

</td>  
<td>

Users=

</td>  
<td>

Users=Clinicians,

</td>  
<td>

Users= Clinicians,

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

**GDPR - Article 25 Obligations**

</th>  
<th>

</th>  
<th>

**Data Phases**

</th>  
<th>

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

**Collection**

**(M1-M42)**

</th>  
<th>

**Processing (M15-M42)**

</th>  
<th>

**Harmonization (M15-M42)**

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

ensure that by default personal data are not made accessible without the
individual's intervention to an indefinite number of natural persons.”

</td>  
<td>

Clinicians

</td>  
<td>

Technical Experts

</td>  
<td>

Technical Experts

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

_Table 30 Data protection by design and by default in HarmonicSS_

##  IPR and ownership

The issues of IPR and ownership with respect to the Integrative Cohort and
project infrastructure are to be clarified by contractual arrangement between
the project parties, namely by conclusion of the IPR MoU (D.3.2, Annex 2).The
separation between rights in data and rights in results produced from data has
been reformulated in Clause 3.1 IPR MoU. Pursuant to Article 24.1 EC-GA, the
Parties, who contribute clinical data into the Project, as entered in the
agreement on background, hold rights in the data. These Parties retain the
rights in the raw data they contribute throughout the duration of the Project
and allow such data to be processed in the Project under the terms as
specified in the agreement on background and/or terms for the grant of Access
Rights, as provided in Section 9, Article 9.2.6 and 9.3 CA, in particular.

As regards ownership in the HarmonicSS Integrative Cohort, qualified as
research result, it would fall under the rules of composite ownership, as
introduced by Clause 4.2 IPR MoU:

_“If Project Results are generated by two or more Parties and if contributions
of the Parties are separately identifiable and/or constitute separate and/or
independent works in themselves, but are assembled into a collective whole as
inter-dependent parts (albeit without an intent to be merged to the point of
being used as a whole only), the contributing Parties agree that such Results
constitute composite work and shall be owned by the contributing Parties
according to the contribution of each.”_

Following this definition, parties contributing pSS datasets into the project
would hold rights in the Integrative Cohort according to the contribution of
each.

It should be noted, however, that given the complexity of the project’s
activities and the accompanying legal analysis, the aforementioned issues are
still under discussion and analysis. The main issues associated with data
protection obligations and management of IPR are expected to be resolved by
M26, as part of the legal and ethical activities in WP3 and the exploitation
plan formulation in WP2.

#  Data Preservation, Sharing and Access

##  Data Preservation

The detailed data used in the HarmonicSS project were described in the
previous sections of the current prototype, being in accordance with the GDPR.
The data will be collected and preserved according to the rules of the GDPR.
Data will be limited and minimized to what is exactly required to carry out
the project by also taking signed consent forms for all users exhibiting the
fair and transparent processing of data. Data will be kept exactly for the
project period and the data subjects will have all the rights that the GDPR
states for them (right of access, right to erasure, right of rectification,
right to restrict processing, right to object to processing, right to data
portability); after the end of the project, the Okeanos administration team
will destroy the hard disks used by the infrastructure service while all
developed data models, techniques, methods and algorithms will be retained as
an entire system. Furthermore, the harmonized large dataset will be kept since
it will provide useful information for clinical specific cases in anonymized
form. The harmonized dataset (a main outcome of the project) will be retained
as an anonymized data repository that will be able to serve future request
cases as enforced by the project’s requirements.

During the project development and according to Article 6 (1.e) of the GDPR
stating that _“Personal data must be kept in a form that permits
identification of data subjects for no longer than is necessary for the
purposes for which the data were collected or for which they are further
processed._ ”, all data - that will be enrolled for the development phases of
the project - will have been decided in the beginning and no future data
requests will be addressed. According to the lawfulness of processing
(including consent forms at the clinical sites) and the data protection by
design, as required by the GDPR regulation, the exact data processing of all
research phases of the project using anonymized and pseudonymized data has
been decided and no future changes for research usage may occur. It should be
noted that HarmonicSS will offer the mechanisms for exporting one or more
pseudonymised data records in any human readable electronic format, provided
that such need rises for respecting any requirement of data portability.

##  Data Sharing and Access

As already mentioned and described in the previous sections, any access to the
HarmonicSS Integrated Cohort will be available only through the HarmonicSS
services with no direct access to the data being allowed. Hence, the data
sharing will be conducted only in the context of HarmonicSS services usage
under the HarmonicSS scenarios implementation and within the HarmonicSS
Consortium. The HarmonicSS data documentation, which will be available at the
project’s website as soon as prepared and finalized (see Section 5), will
present the Reference Model in detail along with specific information
regarding the Results of Scenarios regarding the use the HarmonicSS data and
services.

Regarding the scenarios results (as mentioned in Section 3.2), they will be
available at the project website as soon as they are delivered and they will
be accompanied by metadata including [Scenario ID, Scenario title, Scenario
goal(s), Scenario Implementation (flow of services used), Scenario Result(s),
Scenario Implementer(s), Scenario Implementation Period]. Following the
project timeplan, the first 4 scenarios (i.e., 1) Stratification model for
classifying pSS patients, 2) Validation of existing biomarkers and discovery
of novel ones, 3) Models of lymphomagenesis, and 4) Formulation of common
clinical practices, guidelines and rules) will be available on M36 and the
health policy implementation ones will be on M42. In order for potentially
interested users to search for this data, they will be properly outlined at
the project website as well as their generation will be properly disseminated
through the project dissemination channels. Any user interested in this data
will then register to the project website as a guest and be able to go through
the scenarios results. The user will be prompted to accept specific “Terms of
usage” prior the finalization of the registration These terms will include
specific IPR protection related conditions as well as will guide the user
regarding the required acknowledgement in case of data re-usage. The latter
will also be presented as information to the user when having access to the
scenarios results.

#  Responsibilities and Resources

Regarding the data management related responsibilities, the Data Control
Committee (DCC) consisting of three coordinating partners has been established
to take over the role of data controller for the project. This committee will
be in charge of implementing the DMP and assigning the relevant roles and
responsibilities (from data capture and data quality assurance to metadata
production and data archiving and sharing) as well as ensure that it is
reviewed and revised, if necessary.

The Data Control Committee (DCC) is formed by:

  * **Project coordinator:** ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON (UoA), established in 6 CHRISTOU LADA STR, ATHINA 10561, Greece, VAT number EL090145420, responsible for data protection: _Prof. Dr. Athanasios Tzioufas_ ; 

  

  * **Scientific coordinator** : PANEPISTIMIO IOANNINON (UoI), 74670, established in PANEPISTEMIOYPOLE, PANEPISTEMIO IOANNINON, IOANNINA 45110, Greece, VAT number EL090029284, responsible for data protection: _Prof. Dr. Dimitrios I. Fotiadis_ ; 

  

  * **Clinical coordinator:** UNIVERSITA DEGLI STUDI DI UDINE (DSMB), CF80014550307, established in VIA PALLADIO 8, UDINE 33100, Italy, VAT number IT01071600306, responsible for data protection: _Prof. Dr. Salvatore De Vita_

  

The set-up of data protection framework for the project is led by the
HarmonicSS llegal partner Leibniz Universität Hannover (LUH).

It should be noted that the list of the persons and entities serving as data
controllers, data processors and data providers who will be responsible for
handling data management issues will be included in the letter to the Data
Protection Authority (Greek Data Protection Authority), as soon as HarmonicSS
is in the phase of collecting the data.

#  Conclusions

This document presented the data management plan for the HarmonicSS project,
covering both retrospective data and prospective data, either from old
patients in their follow up visits or new patients.

The document presents in detail the data collection process, the metadata and
accompanying documentation, the storage and back up mechanisms, the data
preservation, sharing and access methods as well as the ethical and legal
compliance of the DMP. Finally, the specific responsibilities regarding the
DMP implementation and review (if required) have been described.