#  Executive Summary

This document outlines the management lifecycle for the data that will be
collected, processed or generated in the scope of the MyPal Action, based on
the guidelines provided by the EU. The MyPal Consortium is committed on an “
_as open as possible and as closed as necessary_ ” approach, focusing on
potential personal privacy issues.

This approach is heavily depending on the national and European legislation
(e.g. the General Data Protection Regulation - GDPR) and a robust ethics
background due to the sensitivity of the data that MyPal will manage. The
three main policy axes for the data management plan (DMP) in MyPal are
summarized as follows:

  1. Data and research results produced at each Action task will be considered for publication using open-access scientific journals and/or open data repositories. 

  

  2. Protection of sensitive data is a priority according to ethical and legal constraints, therefore, each dataset will be thoroughly reviewed with respect to its potential access/sharing. Preferably, data will be published in an aggregative fashion (e.g. average values) not referring to specific persons. When data referring to individuals are decided to be published in order to facilitate further research, these must be anonymized and thoroughly examined for potential privacy issues. 

  

  3. The deliverable provides a clear and detailed approach regarding data management. However, as the project evolves, the DMP will also evolve as part of the respective activities, adapting to potentially new data, defining explicit rules for specific datasets, etc. 

  

  

Five datasets have been identified in the current stage of the project, which
the DMP accounts for:

  * MyPal-ADULT clinical study 

  

  * MyPal-CHILD clinical study 

  

  * Focus groups to extract user requirements 

  

  * Systematic and Mapping Review of use of PRO systems for cancer patients ▪ Internal Expert Questionnaires for technical design 

  

The MyPal clinical studies are expected to produce the two most important and
sensitive datasets of the Action.

While the currently presented DMP clearly outlines the MyPal Consortium’s data
management policy, it should not be considered as a “fixed” document. On the
contrary, the MyPal DMP should be considered as a live/evolving document
during the lifespan of the Action as data are generated and processed,
expected to be updated regularly in the future.

#  Introduction

MyPal aims to foster palliative care for cancer patients via Patient Reported
Outcome (PRO) systems, while focusing on their adaptation to the personal
needs of the cancer patient and his/her caregiver(s). To this end, MyPal
aspires to empower cancer patients and their caregivers in capturing more
accurately their symptoms/conditions, communicate them with a seamless and
effective way to their healthcare providers and, ultimately, foster the time
for action through the prompt identification of important deviations in the
patient’s state and Quality of Life (QoL).

The project’s ambition is to exploit advances in digital health to support
patients, family members and healthcare providers in gaining value through a
systematic and comprehensive PRO-based intervention and, therefore, provide a
paradigm shift from passive patient reporting (through conventional PRO
approaches) to active patient engagement (via personalized and integrated care
delivery) across the entire cancer trajectory.

MyPal will demonstrate and validate the proposed intervention in two different
patient groups, i.e. adults suffering from hematologic malignancies and
children with solid tumours or hematologic malignancies, hence targeting
different age groups and cancer types, through carefully designed clinical
studies that will be conducted in diverse healthcare settings across Europe.
MyPal-ADULT will be a randomized controlled trial (RCT) and MyPal-CHILD an
observational study. As MyPal intends to produce and exploit sensitive
personal health data, data management becomes a top priority, also regulated
by legislation and ethics focusing on patient privacy protection (e.g. the
General Data Protection Regulation – GDPR  1  and the ICH-GCP Guidelines EU
Clinical Trial Directive (2001/20/EG)  2  ). In parallel, as MyPal
participates in the Pilot on Open Research Data  2  , the need for a clear
data management approach which enables open access and reuse of research data
becomes imperative.

This deliverable describes the project’s Data Management Plan (DMP) concerning
the data processed, generated and preserved during and after MyPal, as well as
relative concerns generated from their usage. The deliverable aims to define a
framework outlining the MyPal policy for data management. In particular, this
deliverable covers topics like information about the data, metadata content
and format, policies for access, sharing and re-use and long-term storage and
data management.

The deliverable is organized into following sections:

  * Section 2 refers to the overall data management approach of the project. 

  

  * Section 3 provides details regarding the data sharing approach applied in MyPal. 

  

  * Section 4 describes the datasets identified so far and potential risks with respect to data management. 

  

  * Section 5 concludes the report. 

  

#  Rationale

The main guidelines used to define this DMP are summarized in Table 1\.

**Table 1: DMP guideline documents.**  
  
<table>  
<tr>  
<th>

**Document title**

</th>  
<th>

**Link**

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

European Research Council (ERC) - Guidelines on Implementation of Open Access
to Scientific Publications and Research Data in projects supported by the
European Research Council under Horizon 2020

</td>  
<td>

_http://ec.europa.eu/research/participants/data/ref/h2020/othe r/hi/oa-
pilot/h2020-hi-erc-oa-guide_en.pdf_

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

European Commission, Directorate-General for Research & Innovation -
Guidelines on FAIR Data Management in Horizon 2020

</td>  
<td>

_http://ec.europa.eu/research/participants/data/ref/h2020/gran
ts_manual/hi/oa_pilot/h2020-hi-oa-data-mgt_en.pdf_

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

European Commission, Directorate-General for Research & Innovation - Data
management

</td>  
<td>

_http://ec.europa.eu/research/participants/docs/h2020-fundingguide/cross-
cutting-issues/open-access-data-management/datamanagement_en.htm_

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

European Commission, Horizon 2020 Data Management Plan (DMP) template

</td>  
<td>

_http://ec.europa.eu/research/participants/data/ref/h2020/othe
r/gm/reporting/h2020-tpl-oa-data-mgt-plan-annotated_en.pdf_

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

Since MyPal will handle personal and sensitive health data, legal obligations
significantly affect the respective data management processes. To this end,
legal and ethical restrictions of the project as a whole have been identified
in deliverable “D1.1: MyPal Ethics”: the Convention of Human Rights with
regard to the applications of Biomedicine (the Oviedo Convention) the
Declaration of Helsinki, the EU Charter of Fundamental Rights, the ICH-GCP
Guidelines EU Clinical Trial Directive (2001/20/EG) and the ESMO Clinical
Practice Guidelines for Supportive and Palliative Care which are intended to
provide the user with a set of recommendations for the best standards of
cancer care. The principles of “Privacy by Design” will be complied with i.e.
a development method for privacy-friendly systems and services. Finally, the
General Data Protection Regulation 679/2016 (GDPR) will be the main legal text
followed for data privacy of the participants, as privacy is one of the main
concerns surrounding participation of humans, collection and processing of
data. More specifically, MyPal needs to comply with the following principles
specified in Article 5 of the GDPR:

  * Minimization: Only data that is necessary for this research will be collected. 

  

  * Lawfulness fairness and transparency of processing. 

  

  * Accuracy of the data, i.e. providing the right to the participant to erase or modify inaccurate data. 

  

  * Storage limitation. 

  

  * Integrity and confidentiality (security of the data). 

  

  * Safety of data by a Roles and Rights management. ▪ Data privacy by pseudonymization/anonymization ▪ Accountability of the data controller. 

  

According to the above guidelines and the respective legal artefacts, MyPal
DMP had to fulfil the following three main requirements:

  1. Must focus on the protection of special categories of personal data (sensitive) as imposed by legislation and widely accepted research ethics principles. 

  

  2. Must provide open access and facilitate finding of research data as widely as possible applying the principles of H2020 Open Research Data Pilot (ORDP). 

  

  3. Must be delivered by the 6th month of the project. 

  

  

The two first requirements might be considered contradictory, as they lead to
a delicate balance between openness and data protection. Furthermore, the
delivery of the DMP by the 6  th  month of the project requires the definition
of a DMP early in the project time schedule, before all project aspects are
defined (e.g. clinical studies detailed plan, datasets detailed definition,
technical decisions regarding MyPal ePRO platform etc.).

Therefore, in order to define a clear and practical data management process,
the MyPal Consortium identified the following three policy axes regarding its
DMP:

  1. Data and research results produced at each project task will be considered for publication using open-access scientific journals and/or open data repositories. 

  

  2. Protection of special categories of data (sensitive) will be a priority according to ethical and legal constraints and therefore, each dataset will be thoroughly reviewed with respect to access policies. For example, preferably, data will be published in an aggregative fashion (e.g. average values) not referring to specific persons. Where publication of data referring to individuals is planned in order to facilitate further research, these must be anonymized and thoroughly examined for potential personal privacy issues. 

  

  3. The deliverable of DMP provides a clear and detailed approach regarding data management. However, as the project evolves, the DMP also might evolve as part of the respective activities, adapting to potentially new datasets defining explicit rules for specific datasets and assuring the overall data quality management. Therefore, as project implementation progresses, the presented DMP will be iteratively adjusted in order to reflect these changes. 

  

  

As project implementation progresses, the presented DMP will be iteratively
adjusted in order to reflect changes (e.g. new datasets) and assure the
overall data quality management. The proposed data management lifecycle can be
summarized in the following steps, applied as part of each project activity
(i.e. WP, task etc.) or across project activities, as suitable (Figure 1).

  1. Data management process definition 

  

  

As a first step, the employed dataset will have to be defined. The need for
the respective dataset and a specific plan for its management must be defined
(e.g. description of the dataset, definition of Data Protection Officer – DPO
according to GDPR, definition of the consent process etc.). Furthermore, data
management risks will have to be identified and elaborated through a suitable
threat analysis/risk management approach. Finally, approval by the respective
national or local bioethics committees will be pursued.

  2. Data collection 

  

  

Collection of data will be performed using suitable methods (e.g. surveys),
applying strict confidentiality rules as well as legal and ethical
restrictions. DPO and the respective partners will make sure that the data
collection process is appropriately applied, while measures will be taken to
apply the collection in as unobtrusive a manner as possible.

  3. Data processing 

  

  

As data processing might involve data transformation processes, special care
will be taken to avoid data tampering, enabling tracing the original raw data.
Furthermore, as data processing might require data exchange among partners,
use of external IT infrastructure etc., confidentiality guarantees among the
engaged institutions as well as technical information security best practices
measures will be applied.

  4. Data publication 

  

  

Prior to data publication, the real need for the publication of personal data
will be evaluated. By principle, MyPal consortium has decided that data should
be published in an aggregated fashion. However, if there is a clear need for
personal data to be published, they will be anonymized. Furthermore, MyPal
published data will also comply with open data standards and be accompanied by
metadata (e.g. dates, provenance information etc.) to comply with FAIR
principles  3  .

  5. Data maintenance 

  

  

The MyPal Consortium will maintain data obtained in the project for 15 years,
including both published and originally collected raw datasets. The general
principle is that data should be maintained in the sites where they have been
collected or created. Furthermore, raw data which are not useful for further
research or validation purposes will be deleted in order to minimize potential
personal privacy risks.

**Figure 1: MyPal data management policy**

In order to minimize information security risks, especially regarding the
clinical studies’ data, the MyPal Consortium seriously considers the option to
host sensitive data centrally in the computational infrastructure of CERTH,
due to its information security capabilities and the fact that it is ISO
27000-certified regarding Information Security Management  4  . While this
policy decision significantly affects the DMP presented in this stage of the
project, it is currently reviewed for potential conflicts with national or
European legislations and local sites bioethics committees and therefore
cannot be considered final.

While this deliverable outlines the consortium policy in terms of the DMP,
data will be processed and therefore handled accordingly as part of the
respective work packages (WPs) and tasks. Therefore, DMP could be adjusted
based on the results of other WPs, e.g. the results regarding the intervention
design activities in WP2, the ethics management in WP9 and the risk management
activities as part of WP8. To this end, the DMP will be updated at the end of
each reporting period (in months 18, 36 and 42 of the project) to depict
information on a finer level of granularity as the implementation of the
project is progressing.

#  Data sharing

The MyPal data sharing policy requires that each dataset will be thoroughly
reviewed before getting published/shared. While special actions referring to
the respective dataset might be explicitly defined, the MyPal policy requires
for each dataset the following:

  * Definition of data owner(s); 

  

  * Definition of incentives concerning the data providers; 

  

  * Identification of user groups and the access policies concerning the data; 

  

  * Definition of access procedure and embargo periods; 

  

  * Compliance with the corresponding legal and ethical framework. 

  

As data sharing and publishing of research results in an open-access fashion
is a priority for MyPal, with regard to each project activity (i.e. WP, task
etc.), the following steps are planned:

  1. Select what data should be retained to support validation of the Action finding or datasets that might be considered useful for further research, including research out of the MyPal scope; 

  

  2. Deposit the research data into an online open-access research data repository (at least the data that are for public use). Repositories will be investigated for each dataset individually, evaluating the options in order to promote the specific dataset’s visibility and further reuse, using the most appropriate data standards, the most appropriate access control schemes, and satisfying legal requirements. Such options include: 

     * institutional research data repository, if available; 

  

     * external data archive or repository already established in the MyPal research domain (to preserve the data according to recognized standards); 

  

     * the European sponsored repository: _http://zenodo.org/_ ; 

  

     * other data repositories (searchable here: _http://www.re3data.org_ ), if the aforementioned ones are not eligible. 

  

  

  3. License the data for re-use (Horizon 2020 recommendation is to use CC0 or CC BY); 

  

  4. Provide information on the tools needed for validation, i.e. everything that could help a third party in validating the data (e.g. code, an excel macro etc.). Independent of the selected repository, the authors will ensure that the repository: 

     * Gives the submitted dataset a persistent and unique identifier to ensure that research outputs in disparate repositories can be linked back to particular researchers and grants; 

  

     * Provides a landing page for each dataset, with metadata and guiding information; 

  

     * Helps track if the data has been used by providing access and download statistics; 

  

     * Keeps the data available in the long term; 

  

     * Provides guidance on how to cite the data or relevant MyPal work; 

  

  

  5. Check if the above steps are compatible with the main DMP, and act accordingly (including potential updates to the DMP per se). 

  

  

These steps will be adapted for each dataset identified as part of MyPal
activities and each case will be examined separately, in order to select the
most suitable online repository. The respective dataset owner will have the
main responsibility for the data sharing process.

The clinical sites engaged in data collection and management as a whole are:

  * Università Vita-Salute San Raffaele, Milan, Italy (USR). 

  

  * University Hospital Brno, Czech Republic (FN BRNO). 

  

  * University Hospital of Crete, Greece (PAGNI). 

  

  * Karolinska Institute, Stockholm, Sweden (KI). 

  

  * Hannover Medical School, Hannover, Germany (MHH). 

  

  * Universität des Saarlandes, Saarbrucken, Germany (USAAR). 

  

  * Geniko Nosokomeio Thessalonikis G.Papanikolaou (GPH), linked third-party to CERTH, which will also be involved in data collection as a backup site in the case when not enough patients could be recruited by other clinical partners. 

  

A number of tools (advanced PRO systems via mobile/desktop apps and games,
self-management tools, psychoemotional assessment) will be developed for the
collection, processing and storage of personal sensitive data. These tools
will be further supported by electronic and paper-based questionnaires,
gamification methods for children and advanced user interface approaches (e.g.
embodied conversational agents offering voice-based interaction). The
appropriate questionnaires for use in palliative care that will be employed
for the reporting include:

  * Purpose-made questionnaires to assess the acceptability of ePRO system by patients/family. 

  

  * Purpose-made questionnaires to assess signs and symptoms and promptness of response by healthcare providers, level of care and level of communication. 

  

  * Standardised questionnaires such as: 

  

  * EuroQoL- EQ-5D, a QoL measure (to be used as a cost-effectiveness evaluation tool), 

  

  * European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQC30) 

  

  * EORTC PAT-SAT C-33 to assess satisfaction with care received in the hospital setting or in the clinic 

  

  * Brief Pain Inventory (BPI) to assess pain 

  

  * Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression 

  

  * Edmonton Symptom Assessment Scale (ESAS) to assess patients’ symptoms 

  

##  Policies for data access and sharing

MyPal partners will deposit the research data needed to validate the results
presented in the submitted scientific publications. This timescale applies for
data underpinning the publication and results presented _._ Research papers
written and published during the funding period will be made available with a
subset of the data necessary to verify the research findings. The consortium
will then make a newer, complete version of data, available within 6 months of
Action completion. This embargo period is requested to allow time for
additional analysis and further publication of research findings to be
performed.

Other data (not underpinning the publication) will be shared during the Action
life following a granular approach to data sharing and releasing subsets of
data at distinct periods rather than waiting until the end of the Action, in
order to obtain feedback from the user community and refine it as necessary.

Access schemes for these data are very important, especially regarding the
data produced by clinical processes, explicitly related with specific
individuals, as they could lead to important privacy issues. Therefore, MyPal
policy provides for partial or controlled publication of research data,
including:

  * Authentication systems that limit read access to authorized users only; 

  

  * Procedures to monitor and evaluate access requests one by one. A user must complete a request form stating the purpose for which they intend to use the data; 

  

  * Adoption of a Data Transfer Agreement that outlines conditions for access and use of the data. 

  

The policy for access and sharing of data will be defined on a per dataset
fashion. In general, anonymised and aggregate data will be made freely
available to everyone, whereas sensitive and confidential data will only be
accessed by specific authorised users.

##  Open access to research data

Open access to research data refers to the right to access and re-use digital
research data generated by Actions. EU expects funded researchers to manage
and share research data in a manner that maximizes opportunities for future
research and complies with relevant best practices. Therefore, the MyPal data
sharing policy promotes publishing of dataset which have at least one of the
following characteristics:

  * the dataset has clear scope for wider research use; 

  

  * the dataset is likely to have long-term value for research or other purposes; 

  

  * the dataset has broad utility for reference and use by research communities; 

  

  * the dataset represents a significant output of the research project; 

  

  * the dataset does not expose information which could be used to cause harm to individuals (e.g. patients), especially focusing on their confidentiality, according to applying legislation and research ethics. 

  

Openly accessible research data generated during the MyPal Action must be
disseminated and available for access free of charge, for use cases like data
mining, further research exploitation, reproduction and validation of already
conducted research and its conclusions etc.

As EC emphasizes on the need for publishing data complying with FAIR
principles (Findable – Accessible – Interoperable – Reusable)  5  . The
requirements if “Findable” and “Accessible”, practically correspond to having
data openly available on the internet. However, the requirements of
“Interoperable” and “Reusable” imply the need for: (a) metadata to provide an
in-depth description of data to facilitate the clear definition of their scope
and potential value and (b) use of standards to enable automatic reuse and
processing through IT systems.

The exact definition of these metadata and standards will be part of each
dataset publication process, as it might be related with the specific dataset
use cases. Publishing data as simple spreadsheets might be suitable for simple
data analysis, whereas publishing data using other more complex formats might
be a necessity depending on their scope. For example, CDISC  6  might be
selected as a more appropriate data format in order to publish produced data
in clinical trial registries, or Resource Description Framework – RDF  7
might be selected to facilitate the reuse of published data in Knowledge
Graphs according to the Linked Data paradigm.

Since most of the data in MyPal will be produced from local systems, their
publication metadata will include provenance information, including the
following:

  * Time stamp for when the data was generated; 

  

  * Data owner (including contact information); 

  

  * Data producing authority; 

  

  * Dataset versioning information explaining potential changes between versions; 

  

  * Licensing information; 

  

  * Unique identifier for the dataset (e.g. Document Object Identifier - DOI) 

  

Documenting datasets, data sources and the methodology used for acquiring the
data establishes the basis for the interpretation and appropriate usage of the
data. Each generated/collected and deposited dataset will include
documentation to help users to re-use it. If limitations exist for the
generated data, these restrictions will be clearly described and justified.

Potential issues that could affect how data can be shared and used may include
the need to protect participant confidentiality, comply with informed consent
agreement, protect Intellectual Property Rights, submit patent applications
and protect commercial confidentiality. Possible measures that may be applied
to address these issues include encryption of data during storage and
transfer, anonymisation of personal information, development of Data Transfer
Agreements that specify how data may be used, specification of embargo
periods, and development of procedures and systems to limit access to
authorised users only.

##  Open access to scientific publications

Open access to scientific publications refers to free of charge online access
for end users in order to promote further research without barriers. Open
access will be achieved through the following steps:

  1. All papers will be deposited at least by the time of publication to a formal repository for scientific papers ( _https://www.openaire.eu/participate/deposit/idrepos_ ). If no other suitable repository is found, the European sponsored repository for scientific papers will be used: _http://zenodo.org/_ . 

  

  2. Authors can choose to pay “author processing charges” to ensure open access publishing, but still they have to deposit the paper in a formal repository for scientific papers. 

  

  3. Authors will ensure open access via the repository to the bibliographic metadata identifying the deposited publication. More specifically, the following will be included: 

     * The terms “ _European Union (EU)_ ” and “ _Horizon 2020_ ”; 

  

     * “ _MyPal: Fostering Palliative Care of Adults and Children with Cancer through Advanced Patient Reported Outcome Systems_ ”, Grant agreement number 825872; ▪ Publication data, length of embargo period if applicable; and 

  

     * A persistent identifier. 

  

  

  4. Each case will be examined separately in order to decide on self-archiving or paying for open access publishing. 

  

  

It should be noted that as part of the MyPal publication policy, published
papers should also include the following acknowledgement: “ _The research
leading to these results has received funding from the European Union’s
Horizon 2020 research and innovation programme under grant agreement No
825872-MyPal_ ” and display the EU emblem.

##  Archiving and presentation

According to the MyPal data management policies, datasets will be maintained
for 15 years in the clinical sites where they have been collected or created.
Clinical study data are excluded from this rule as, due to their high
sensitivity, MyPal consortium decided to host them centrally in CERTH which
holds an ISO 27000 Information Security Management certification. To ensure
high-quality long-term management and maintenance of the dataset, the
consortium will implement procedures to protect information over time. These
procedures will permit a broad range of users to easily obtain, share and
properly interpret both active and archived information and they will ensure
that information is:

  * Kept up-to-date in content and format so that they remain easily accessible and usable; 

  

  * Protected from catastrophic events (e.g., fire and flood), user error, hardware failure, software failure or corruption, security breaches, and vandalism. 

  

Regarding the second aspect, solutions dealing with disaster risk management
and recovery, as well as with regular backups of data and off-site storage of
backup sets, are always integrated when using the official data repositories
(i.e., _http://zenodo.org/_ ); the partners will ensure the adoption of
similar solutions when choosing an institutional research data repository.

Partners are encouraged to claim costs for resources necessary to manage and
share data; these will be clearly described and justified. Arrangements for
post-action data management and sharing must be made during the life of the
Action. Costs associated with long-term curation and preservation, such as
POSF (Pay Once, Store Forever) storage, will be purchased before the Action
ends.

#  Datasets

The datasets described here are those identified at the 6  th  month of the
project, and therefore cannot be considered definite. However, these dataset
descriptions are provided to provide a clear pathway on how the overall MyPal
data management policy might be applied through the whole project.

The users engaged in the MyPal project can be categorized as following:

  * Adult patients 

  

  * Children patients 

  

  * Informal carers (typically patients’ family) ▪ Healthcare professionals 

  

At the current stage of the project, the data engaged in the project can be
categorized as following:

  * Electronic Health Records 

  

  * Personal demographics 

  

  * Lifestyle/behavioral data 

  

  * Responses to structured questionnaires 

  

  * Psychosomatic information 

  

According to GDPR Article 4.1. “personal data is defined as any information
relating to an identified or identifiable natural person (‘data subject’); an
identifiable natural person is one who can be identified, directly or
indirectly, in particular by reference to an identifier such as a name, an
identification number, location data, an online identifier or to one or more
factors specific to the physical, physiological, genetic, mental, economic,
cultural or social identity of that natural person”. In the context of MyPal,
this refers to the following identifiers: names, email addresses, medical
records, home/work addresses, phone numbers and other data linked directly to
individual users. Sensitive data constitute a big part of this collection, for
example, questionnaire-based tools and applications to monitor patients’
stress, anxiety, depression and related negative impact of the disease on
their lives and social relations will be used. At this stage of the project,
the collection of sensory data for objective physical activity assessment
(e.g. step measurement) is also planned.

The description of the identified datasets and the respective data management
activities follows the rationale of the Horizon 2020 DMP template  8  while
for each dataset, the respective document based on the ERC template  10  is
provided as an appendix. Since the most important project activities regarding
the presented DMP are the two clinical studies which have not yet been fully
designed (i.e. MyPal ADULT randomized control trial (RCT) and MyPal CHILD non-
interventional observational study (OS)), the respective dataset descriptions
cannot be finalized, but rather described in a more abstract manner.

##  MyPal-ADULT clinical study

###  Data Summary

MyPal-ADULT is an RCT planned to involve 300 patients with hematologic
malignancies, planned to start on month 17 and end on M42 of the project. Two
groups of adult patients will be employed: (a) an intervention group will use
the MyPal ePRO system and (b) a control group will receive typical palliative
care if desired.

The user categories engaged in this clinical study data management process
are: (a) adult patients and (b) healthcare professionals. As part of the MyPal
ADULT clinical study, the EORTC QLQ-C30 General Questionnaire and EQ-5D
(Czech, Greek, Italian, Swedish version) will be used to measure the
improvement of quality of life of patients every month for the first six
months and at the end of the clinical study to provide psychosomatic,
behavioural and lifestyle information for the patient. In addition, patient
and healthcare professional demographic data, along with medical history and
necessary EHR information will be employed. This data will enable the
calculation of scores for various well-defined scales (e.g. EORTC Satisfaction
with Cancer Care questionnaire, etc.).

More specifically, MyPal-ADULT dataset is expected to include the following
subsets:

  * Assessment dataset: all the data collected for the assessment of the study outcomes that are associated with the endpoints of the study – electronically collected assessment scale (i.e., questionnaire data regarding QoL, satisfaction with care, etc.) & clinical information (e.g., overall survival). 

  

  * Intervention dataset: all the data collected as part of the developed eHealth intervention: includes electronically collected assessment scale data concerning cancer-related symptoms (e.g., Brief Pain Inventory, Edmonton Symptom Assessment Scale, etc.), lifestyle data (daily steps, sleep quality) coming from sensory device, clinical data (e.g., diagnosis), treatment/medication plan, etc. 

  

The data collection process will entail answering of the respective
questionnaires using electronic or other means (e.g. interviews) while also
employing the MyPal ePRO platform. The data collected will be typically stored
in spreadsheet files (e.g. csv, or Microsoft Excel files) and would be used by
the consortium researchers to produce statistics that could assess the planned
intervention’s feasibility and improvement on overall patient’s quality of
life. The size of the collected data is estimated at 500MBs.

Data processing will mostly focus on the calculation of the various scores
regarding the improvement of the patient’s quality of life and various
statistic measures. No special needs for data processing can be identified.
Therefore, it is assumed that the respective index scores or the patient group
statistics can be calculated on each clinical site with no need for data
exchange. If data need to be exchanged among consortium members (e.g. for
validation or other purposes) they will only include anonymized information,
after written guarantees regarding data security have been provided.

###  FAIR data

_**Making data findable, including provisions for metadata** _

MyPal-ADULT data will be available online after anonymization, accompanied
with suitable metadata to facilitate finding via search engines. Furthermore,
suitable openly accessible data repositories will be selected to store the
produced data using persistent and unique identifiers (e.g. DOI) in order to
enable unambiguous identification of the dataset and referencing in future
research, either by MyPal consortium or other researchers.

_**Making data openly accessible** _

While at the current stage of the project, scientific publications or data
publications could not be defined, MyPal consortium is committed to publishing
anonymized data to the extent possible, using openly accessible data
repositories. Similarly, open access scientific journals will be employed for
scientific publications. Indicatively, outlining a publication plan, the
following 3 data or research results publications could be outlined:

  1. The clinical study’s _research protocol_ will be published in EU Clinical Trials Register (EU-CTR)  9  could be published in an open access scientific journal like “JMIR Research Protocols”  10  , “BMJ Open”  11  , “BMC Cancer”  12  and “International Journal of Clinical Trials”  13  , always in accordance with the International Committee of Medical Journal Editors (ICMJE) recommendations  14  . 

  

  2. The MyPal-ADULT produced _datasets_ could be published (after thorough anonymization) in the clinicaltrials.gov _ 17  _ . “Janus clinical trial data repository”  15  will also be evaluated as a potential repository in order to maximize future data reuse. However, since Janus currently focuses on data “ _submitted to FDA as part of a regulatory submissions_ ”, it might not be relevant to MyPal-ADULT study. Other repositories will also be evaluated (indicative such lists are published by UCL  16  , Cancer Research UK  17  , and Nature Scientific Data  21  ). It should be noted that in any case, prior to data publication, the respective data repository will be evaluated regarding its adherence to FAIR principles, ensuring that MyPal is compatible with the goals of ORDP. 

  

  3. The overall evaluation of the MyPal-ADULT study will be published in open access scientific journal, possibly referring to the respective datasets. “JMIR”  18  and “JMIR mHealth and uHealth”  23  could be identified as a potentially suitable journal. 

  

  

_**Making data interoperable** _

Data will be published applying open access formats (e.g. csv files) to
facilitate further reuse and data validation without the need for specific
vendor tools and software. Furthermore, widely accepted terminologies and
vocabularies will be used to the extent possible (e.g. ICD for diagnoses, ATC
for drugs and MedDRA for adverse drug events) to enable unambiguous semantic
interpretation of data.

_**Increase data re-use (through clarifying licences)** _

The full data regarding scientific publications will be available at the
moment of publication. Full dataset will be available within 6 months of
Action completion to allow time for additional analysis and potential further
results publication while protecting the consortium’s Intellectual Property
Rights (IPR). Data will be able to be reused from the moment they will be
published. Data will be licensed using appropriate open access licenses, based
on Creative Commons. In order to assure quality control procedures, MyPal
consortium will apply proper internal review processes. Furthermore, peer
reviewed scientific publications will be pursued to assure high quality
interpretation of the produced data.

###  Allocation of resources

A DPO will be defined for each clinical site participating in the study, in
compliance with GDPR. Finally, as already outlined in the overall MyPal
policy, data (both processed and raw collected data) will be maintained for 15
years, either locally (for low risk data) or centrally in CERTH which is
certified for its information management processes (for high risk data). Costs
for long term storage of results are eligible in the context of MyPal and the
respective partners will have the responsibility of cost management.

###  Data security

Data management risks/threats can be identified based on a widely used
information security threat analysis model, i.e. the STRIDE model  19  , as
following:

  * _Spoofing_ could refer to intercepting information for any reason, violating patient’s privacy or the MyPal consortium’s work in terms of confidentiality in order to cause harm (e.g. personal harm) or gain benefits (e.g. intellectual property rights’ issues). 

  

  * _Tampering_ could refer to altering collected data. Tampering includes modifications conducted either by mistake or on purpose, in order to cause harm to the patient or MyPal consortium. 

  

  * _Repudiation_ refers to the risk of falsely denying the validity of an action, denouncing responsibility for it. In MyPal context, an example could refer to a clinician denying that he/she is responsible for a clinical act in order to avoid legal or other consequences. 

  

  * _Information disclosure_ could refer to revealing information either to harm the patient or MyPal consortium or to provide other kind of benefits to the malicious user (e.g. financial benefit via disclosing information to insurance companies). 

  

  * _Denial of Service_ could refer to stealing data in order to stop the service of MyPal (e.g. the MyPal ePRO platform) either to cause harm to the patient or the MyPal consortium, or in order to provide other kind of benefits for the malicious user (e.g. for competition reasons). 

  

  * _Elevation of privilege_ could refer to providing access to a non-legitimate user in order to exploit collected data. 

  

To successfully mitigate such information management risks, the produced data
will be hosted by CERTH (instead of the respective clinical sites) which holds
an ISO 27000 standard regarding its Information Security practices.

###  Ethical aspects

The overall design of the study will be approved by all clinical sites local
research ethics committees as well as by any authorities defined by local or
European laws. Regarding ethics and legal issues, the overall process will be
governed by widely accepted best practices which can be enumerated as
following:

  * Ethical principles of the Declaration of Helsinki 

  

  * The General Data Protection Regulation (GDPR) 

  

  * ICH-GCP Guidelines 

  

  * EU Clinical Trial Directive (2001/20/EG) 

  

  * ICH E9 statistical principles for clinical trials 

  

  * ESMO Clinical Practice Guidelines for Supportive and Palliative Care 

  

  * Guidelines of the National Consensus Project for Quality Palliative Care 

  

  * NCCN Guidelines Insights: Palliative Care, Version 2.2017 

  

The consent process will provide documents to be signed after information
sheets regarding MyPal have been provided to potential participants.
Furthermore, a questions-and-answers session will be conducted enabling the
clarification of patients’ concerns and providing explanations to them. As
also explained in the clinical study definition, a copy of the informed
consent form will be given to the subject and the original will be placed in
the subject's medical record. Draft versions of the information sheets and the
respective consent documents have been already defined in the context of the
deliverable “D1.1: MyPal Ethics” and are also provided in this DMP for easy
reference in Appendix A and Appendix B.

Appendix C provides the data management plan for the MyPal ADULT study dataset
following the respective ERC template.

##  MyPal-CHILD clinical study

###  Data Summary

MyPal-CHILD is planned as an observational, non-interventional clinical study
of the MyPal ePRO-based early palliative care system in 100 paediatric
oncology patients (6-18 years of age). The clinical study will start at month
17, and end at month 42 of the project focusing on two groups of patients,
i.e. paediatric patients Acute Lymphoblastic Leukaemia (ALL) and paediatric
patients with solid cancers. Even though MyPal-CHILD is a less intrusive
observational study, compared to MyPal-ADULT which is an RCT, similar
principles apply.

The user categories engaged in this clinical study data management process
are: (a) child patients, (b) healthcare professionals, and (c) informal
carers. As part of the MyPal-CHILD clinical study, the Impact on Family Scale
and the EORTC PATSAT – C33 Parent version questionnaire will be used to assess
the informal carers’ burden, priorities and satisfaction regarding healthcare
services. In addition, patient and healthcare professional demographic data,
along with medical history and necessary EHR information will be employed.

More specifically, the MyPal-CHILD dataset is expected to include the
following subsets:

  * Assessment dataset: all the data collected for the assessment of the study outcomes that are associated with the endpoints of the study – electronically collected assessment scale data (i.e., questionnaire data regarding QoL, satisfaction with care, etc.) and clinical information (e.g., overall survival). 

  

  * Intervention dataset: all the data collected as part of the developed eHealth intervention: includes electronically collected assessment scale data concerning cancer-related symptoms (e.g., Memorial Symptom Assessment Scale, etc.), information obtained via a serious game planned to be developed, lifestyle data (daily steps, sleep quality) coming from sensory device, clinical data (e.g., diagnosis), treatment/medication plan, etc. 

  

The data collection process will employ the answering of the respective
questionnaires using electronic or other means (e.g. written answers or
interviews) while also employing the MyPal ePRO platform. The data collected
will be typically stored in spreadsheet files (e.g. csv, or Microsoft Excel
files) and would be used by the consortium researchers to produce statistics
that could assess the planned intervention’s feasibility and improvement on
overall patient’s quality of life. The size of the collected data is estimated
at 100MBs.

Data processing will mostly focus on the calculation of the various scores
regarding the improvement of the patient’s quality of life, the burden on the
informal carers and various statistic measures. No special needs for data
processing can be identified at this stage of the project and therefore, it is
assumed that the respective index scores or the patient group statistics can
be calculated on each clinical site with no need for data exchange. If data
need to be exchanged among consortium members (e.g. for validation or other
purposes) they will only include anonymized information, after written
guarantees regarding data security have been provided.

###  FAIR data

_**Making data findable, including provisions for metadata** _

MyPal CHILD data will be available online after anonymization, accompanied
with suitable metadata to facilitate finding via search engines. Furthermore,
suitable openly accessible data repositories will be selected to store the
produced data using persistent and unique identifiers (e.g. DOI) in order to
enable unambiguous identification of the dataset and referencing in future
research, either by MyPal consortium or other researchers.

_**Making data openly accessible** _

While at the current stage of the project, research results publications or
data publications could not be defined in detail, MyPal consortium is
committed in publishing anonymized data to the extent possible, using openly
accessible data repositories. To this end, open access scientific journals
will be employed for scientific publications. Indicatively, outlining a
publication plan, the following 3 datasets or research results publications
could be outlined:

  1. The clinical study’s _research protocol_ could be published in an open access scientific journal like “JMIR Research Protocols”, “Journal of Paediatric Haematology / Oncology”  20  , “Paediatric Haematology and Oncology”  21  and “Paediatric Haematology Oncology Journal”  22  . 

  

  2. Since no repositories directly related with the scenario of MyPal CHILD study could be identified (at least in this stage of the project), the produced _datasets_ could be published (after thorough anonymization) in local institutional or other open access repositories (e.g. zenodo). It should be noted, that in any case, prior to data publication, the respective data repository will be evaluated regarding its adherence to FAIR principles, ensuring that MyPal is compatible with the goals of ORDP. 

  

  3. The overall evaluation of the MyPal-CHILD study will be published in an open access scientific journal, possibly referring to the respective datasets. “JMIR”, “Journal of Paediatric Haematology / Oncology”, “Paediatric Haematology and Oncology” and “Paediatric Haematology Oncology Journal” have been identified as potentially suitable journals. 

  

  

_**Making data interoperable** _

Data will be published applying open access formats (e.g. csv files) to
facilitate further reuse and data validation without the need for specific
vendor tools and software. Furthermore, widely accepted terminologies and
vocabularies will be used to the extent possible (e.g. ICD for diagnoses, ATC
for drugs and MedDRA for adverse drug events) to enable unambiguous semantic
interpretation of data.

_**Increase data re-use (through clarifying licences)** _

The full data regarding scientific publications will be available at the
moment of publication. Full dataset will be available within 6 months of
Action completion to allow time for additional analysis and potential further
results publication while protecting the consortium’s IPR. Data will be
licensed using appropriate open access licenses, based on Creative Commons. In
order to assure quality control procedures, MyPal consortium will apply proper
internal review processes. Furthermore, peer reviewed scientific publications
will be pursued to assure high quality interpretation of the produced data.

###  Allocation of resources

A DPO will be defined for each clinical site participating in the study, in
compliance with GDPR. Finally, as already outlined in the overall MyPal
policy, data (both processed and raw collected data) will be maintained for 15
years, either locally (for low risk data) or centrally in CERTH which is
certified for its information management processes (for high risk data). Costs
for long term storage of results are eligible in the context of MyPal and the
respective partners will have the responsibility of cost management.

###  Data security

Similarly to the MyPal-ADULT study, data management risks/threats can be
summarized using the STRIDE model as following:

  * _Spoofing_ could refer to intercepting information for any reason, violating patient’s privacy or the MyPal consortium’s work in terms of confidentiality. 

  

  * _Tampering_ could refer to altering collected data either by mistake or on purpose, in order to cause harm to the patient or MyPal consortium. 

  

  * _Repudiation_ refers to the risk of falsely denying the validity of an action, denouncing responsibility for it. In MyPal context, an example could refer to a clinician denying that he/she is responsible for a clinical act in order to avoid legal or other consequences. 

  

  * _Information disclosure_ could refer to revealing information either to harm the patient or MyPal consortium or to provide other kind of benefits to the malicious user (e.g. financial benefit via disclosing information to insurance companies). 

  

  * _Denial of Service_ could refer to stealing data in order to stop the service of MyPal (e.g. the MyPal ePRO platform) either to cause harm to the patient or the MyPal consortium, or in order to provide other kind of benefits for the malicious user (e.g. for competition reasons). 

  

  * _Elevation of privilege_ could refer to providing access to a non-legitimate user in order to exploit collected data . 

  

To successfully mitigate such information management risks, similarly with the
MyPal-ADULT study, the produced data will be hosted by CERTH (instead of the
respective clinical sites) which holds an ISO 27000 standard regarding its
Information Security practices.

###  Ethical aspects

The study design will be approved by all clinical sites local research ethics
committees as well as by any authorities defined by local or European laws.
Similar to the MyPal-ADULT study, regarding ethics and legal issues, the
overall process will be governed by widely accepted best practices which can
be enumerated as following:

  * Ethical principles of the Declaration of Helsinki 

  

  * The General Data Protection Regulation (GDPR) 

  

  * ICH-GCP Guidelines 

  

  * EU Clinical Trial Directive (2001/20/EG) 

  

  * ICH E9 statistical principles for clinical trials 

  

  * ESMO Clinical Practice Guidelines for Supportive and Palliative Care 

  

  * Guidelines of the National Consensus Project for Quality Palliative Care 

  

  * NCCN Guidelines Insights: Palliative Care, Version 2.2017 

  

The consent process will provide consent documents to be signed after
information sheets regarding MyPal have been provided to potential
participants. Furthermore, a questions-and-answers session will be conducted
enabling the clarification of patients’ worries and providing explanations to
them. As also explained in the clinical study definition, a copy of the
informed consent form will be given to the subject and the original will be
placed in the subject's medical record. Draft versions of the information
sheets and the respective consent documents have been already defined in the
context of the deliverable “D1.1: MyPal Ethics” and are also provided in this
DMP for easy reference in Appendix A and Appendix B.

Appendix D provides the data management plan for the MyPal-CHILD study dataset
following the respective ERC template.

##  Focus groups to extract user requirements

###  Data Summary

In the context of “Task 2.1: MyPal palliative care context and user needs” a
number of focus groups meetings have been conducted in all clinical sites of
the project, including various stakeholders (e.g. clinicians, patients,
informal carers etc.). The purpose of these focus groups was to enable a live
discussion, identify potential user requirements and get end-user feedback
regarding the overall idea of MyPal. To this end, all focus groups have been
recorded and analyzed by local clinical partners to extract meaningful
information regarding user requirements. Furthermore, semi-structured
questionnaires in paper form have been used to collect user feedback.

The first level of data processing, (i.e. the extraction of useful information
from sound recordings, and the analysis of the questionnaires) has been
conducted locally on each clinical site due to both legal and practical
restrictions, as the centralized analysis of locally collected data would
require its transcription/translation. The local partners transcoded the
extracted information in English, and all the information from clinical sites
has been collected using spreadsheet files created by CERTH to collect
anonymized and aggregated data which are further analyzed centrally.

Locally collected and stored data include sound recordings and spreadsheet
files (typically in csv format). Centrally analyzed data are also stored in
spreadsheet files and they are used in order to produce graphical
representations of the collected results to facilitate the decisions regarding
the technical design of the system.

The dataset size could be estimated at about 5MBs of data in a simple CSV
format and about 1GB of sound recording files.

###  FAIR data

_**Making data findable, including provisions for metadata** _

Focus groups raw data (i.e. sound recordings, initial questionnaire responses)
will not be available online in order to protect user privacy. This decision
was made in order to reduce reluctance for stakeholders to participate in
focus groups and also facilitate the expression of opinion. However, the
results of the respective analysis will be available with suitable metadata to
facilitate finding via search engines. Furthermore, suitable openly accessible
data repositories will be selected to store the produced data using persistent
and unique identifiers (e.g. DOI) in order to enable unambiguous
identification of the dataset and referencing in future research, either by
MyPal consortium or other researchers.

_**Making data openly accessible** _

While at the current stage of the project, scientific publications or data
publications could not be explicitly defined, MyPal consortium is committed in
publishing anonymized data to the extent possible, using openly accessible
data repositories. Since no purpose specific data repositories have been
identified, Zenodo or institutional repositories will probably be used to make
data openly accessible. Similarly, open access scientific journals will be
employed for scientific publications. The analysis of the focus groups data is
planned to be published as part of the overall project’s “User requirements”
analysis process and “BMC Medical Informatics and Decision Making”  23  has
already been identified as potential publishing.

_**Making data interoperable** _

Data will be published applying open access formats (e.g. csv files) to
facilitate further reuse and data validation without the need for specific
vendor tools and software. No widely accepted terminologies/vocabularies could
be identified for this purpose.

_**Increase data re-use (through clarifying licences)** _

The full data regarding scientific publications will be available at the
moment of publication. Full dataset will be available within 6 months of
Action completion to allow time for additional analysis and potential further
results publication while protecting the consortium’s IPR. Data will be
licensed using appropriate open access licenses, based on Creative Commons. In
order to assure quality control procedures, MyPal consortium will apply proper
internal review processes. Furthermore, peer reviewed scientific publications
will be pursued to assure high quality interpretation of the produced data.

###  Allocation of resources

A DPO will be defined for each clinical site participating in the study, in
compliance with GDPR. Finally, as already outlined in the overall MyPal
policy, data (both processed and raw collected data) will be maintained for 15
years. Costs for long term storage of results are eligible in the context of
MyPal and the respective partners will have the responsibility of cost
management. Regarding publication costs, the leader partner of the publication
will handle the publication costs, in cooperation with other partners if
needed.

###  Data security

Focus group data security issues mostly refer to the data stored locally on
clinical partners site. While the data produced by the analysis process are
considered as low risk data (as they cannot lead to personal privacy risks),
the original raw data (questionnaire responses and sound recordings) might be
related with some security risks, e.g. the identification of patients and
implicit medical history information. Therefore, the local clinical sites and
the respective DPO are considered responsible for the respective data
maintenance. In cases where the local clinical sites are not able to guarantee
information security of these data, they will be able to use CERTH
infrastructures (which is certified for its Information Security Management
approaches with ISO 27000), always under the restrictions of local bioethics
committee’s approval and compatibility with national and European laws.

###  Ethical aspects

The focus groups analysis was designed according to current Research Ethics
guidelines as articulated in the European Commission’s ‘Ethics for
Researchers’, issued for the 7th Framework Programme (FP7). The only data
management related activity based on ethics is the need to maintain the
originally collected data (i.e. sound recordings and questionnaire responses)
confidential to protect participants’ privacy.

Appendix E provides the data management plan for the focus groups dataset
following the respective ERC template.

##  Systematic and Mapping Review of use of PRO systems for cancer patients

###  Data Summary

In the context of “T1.2: PRO systems in palliative cancer care”, a Systematic
and Mapping Review is conducted regarding the applications of PRO systems for
cancer patients. During this process, a large number of related scientific
publications has been reviewed to identify and quantify the characteristics
and the trends of the PRO approaches in the context of cancer treatment.

To this end, CERTH, FRAU and FORTH analyze the eligible publications and map
them to a well-defined set of criteria. These data are not sensitive by any
means and are maintained using spreadsheet files in csv format, with a size
estimated at about 5MBs.

###  FAIR data

_**Making data findable, including provisions for metadata** _

Systematic and Mapping Review data will be available online, accompanied with
suitable metadata to facilitate finding via search engines. Furthermore,
suitable openly accessible data repositories will be selected to store the
produced data using persistent and unique identifiers (e.g. DOI) in order to
enable unambiguous identification of the dataset and referencing in future
research, either by MyPal consortium or other researchers.

_**Making data openly accessible** _

While at the current stage of the project, scientific publications or data
publications could not be explicitly defined, MyPal consortium is committed in
publishing anonymized data to the extent possible, using openly accessible
data repositories. “Systematic Data Review Repository (SRDR)”  24  provided by
U.S. Department of Health & Human Services will be considered to publish the
collected data. Furthermore, the Systematic and Mapping Review protocol will
be published in Prospero  25  . Similar with the other datasets, open access
scientific journals will be employed for scientific publications. “Clinical
Cancer Informatics”  26  is identified as a potential target journal for
publication. Finally, Cochrane library of systematic reviews  27  will also be
considered for publication of the respective Systematic and Mapping Review
protocol and results.

_**Making data interoperable** _

Data will be published applying open access formats (e.g. csv files) to
facilitate further reuse and data validation without the need for specific
vendor tools and software. No widely accepted terminologies/vocabularies could
be identified for this purpose, apart perhaps from the use of MeSH keywords
28  which are widely used to organize medical scientific publications.

_**Increase data re-use (through clarifying licences)** _

The full data regarding scientific publications will be available at the
moment of publication. Full dataset will be available within 6 months of
Action completion to allow time for additional analysis and potential further
results publication while protecting the consortium’s IPR. Data will be
licensed using appropriate open access licenses, based on Creative Commons. In
order to assure quality control procedures, MyPal consortium will apply proper
internal review processes. Furthermore, peer reviewed scientific publications
will be pursued to assure high quality interpretation of the produced data.

###  Allocation of resources

Since no personal or sensitive data are engaged in this dataset, there is no
need to define a specific DPO. As already outlined in the overall MyPal
policy, data (both processed and raw collected data) will be maintained for 15
years.

Costs for long term storage of results are eligible in the context of MyPal
and the respective partners will have the responsibility of cost management.
Regarding publication costs, the leader partner of the publication will handle
the publication costs, in cooperation with other partners if needed.

###  Data security

No personal or sensitive data are involved in this dataset, therefore no
information management security risks are related apart from the ones
regarding the protection of the MyPal consortium Intellectual Property Rights
(IPR). To this end, CERTH which leads the current activity will maintain data
for 15 years, applying certified information security management practices and
no specific measures are required.

###  Ethical aspects

The only ethical aspect regarding the Systematic and Mapping Review refers to
the use of widely accepted scientific methodologies to ensure the produced
results quality and research integrity. To this end, PRISMA methodology will
be applied  29  along with widely accepted scientific publications best
practices (e.g. COPE guidelines  30  ).

Appendix F provides the data management plan for the “Systematic and Mapping
Review” dataset following the respective ERC template.

##  Internal Expert Questionnaires for technical design

###  Data Summary

In the context of “Task 2.1: MyPal palliative care context and user needs” a
series of questionnaires has been created and circulated among MyPal
consortium experts, in order to facilitate the technical requirements
engineering process and design of the system, prioritization of ICT system
features and answering to open-blocking questions regarding technical design
and development of the ePRO platform.

Data processing has been conducted by CERTH using data collected via Google
forms, typically in spreadsheet files. These data have been used in the
project’s requirements engineering process and are used to produce graphical
representations of the collected results to facilitate the decisions regarding
the technical design of the system. The dataset size could be estimated at
about 5MBs.

###  FAIR data

_**Making data findable, including provisions for metadata** _

“Internal Expert Questionnaires” raw data will be available online after
anonymization, accompanied with suitable metadata to facilitate finding via
search engines. Furthermore, suitable openly accessible data repositories will
be selected to store the produced data using persistent and unique identifiers
(e.g. DOI) in order to enable unambiguous identification of the dataset and
referencing in future research, either by MyPal consortium or other
researchers.

_**Making data openly accessible** _

While at the current stage of the project, scientific publications or data
publications could not be explicitly defined, MyPal consortium is committed in
publishing anonymized data to the extent possible, using openly accessible
data repositories. Since no purpose-specific data repositories have been
identified, Zenodo or institutional repositories will probably be used to make
data openly accessible. Similarly, open access scientific journals will be
employed for scientific publications. The analysis of the internal experts
questionnaires is planned to be published as part of the overall project’s
“User requirements” analysis process and “BMC Medical Informatics and Decision
Making” has already been identified as potential publishing.

_**Making data interoperable** _

Data will be published applying open access formats (e.g. csv files) to
facilitate further reuse and data validation without the need for specific
vendor tools and software. No widely accepted terminologies/vocabularies could
be identified for this purpose.

_**Increase data re-use (through clarifying licences)** _

The full data regarding scientific publications will be available at the
moment of publication. Full dataset will be available within 6 months of
Action completion to allow time for additional analysis and potential further
results publication while protecting the consortium’s IPR. Data will be
licensed using appropriate open access licenses, based on Creative Commons. In
order to assure quality control procedures, MyPal consortium will apply proper
internal review processes. Furthermore, peer reviewed scientific publications
will be pursued to assure high quality interpretation of the produced data.

###  Allocation of resources

Since no personal or sensitive data are engaged in this dataset, there is no
need to define a specific DPO. As already outlined in the overall MyPal
policy, data (both processed and raw collected data) will be maintained for 15
years. Costs for long term storage of results are eligible in the context of
MyPal and the respective partners will have the responsibility of cost
management. Regarding publication costs, the leader partner of the publication
will handle the publication costs, in cooperation with other partners if
needed.

###  Data security

No personal or sensitive data are involved in this dataset, therefore no
information management security risks are related apart from the ones
regarding the protection of the MyPal consortium Intellectual Property Rights
(IPR). To this end, CERTH which leads the current activity will maintain data
for 15 years, applying certified information security management practices and
no specific measures are required.

###  Ethical aspects

The only ethical aspect regarding the “Internal expert questionnaires” refers
to the use of widely accepted scientific methodologies to ensure the produced
results quality and research integrity. To this end, COPE guidelines will be
applied along with widely accepted research ethics best practices.

Appendix G provides the data management plan for the “Internal Expert
Questionnaires” dataset following the respective ERC template.

#  Conclusions

The purpose of this deliverable is to provide a clear DMP to support the
management lifecycle for all the data that will be collected, processed or
generated by the MyPal Action. This DMP is produced based on EU provided
guidelines and outlines the MyPal policy regarding research results and data
sharing.

In summary, the MyPal Consortium is committed on an “ _as open as possible and
as closed as necessary_ ” approach, focusing on potential personal privacy
issues. This approach is heavily dependent on the national and European
legislation (e.g. GDPR) and a robust ethics background due to the sensitivity
of the data to be managed.

Five datasets have been identified in the current stage of the project, for
which a first data management plan, including potential publications has been
made. The two clinical studies, MyPal-ADULT and MyPal-CHILD, are expected to
produce the two most important and sensitive datasets of the project. Three
more datasets identified as part of ongoing activities are also presented.

While the currently presented DMP clearly outlines the MyPal consortiums data
management policy, it should not be considered a fixed document. On the
contrary, MyPal DMP should be considered a live evolving document during the
lifespan of the Action as data are generated and processed, expected to be
updated regularly in the future.

Regarding the future updates of the presented DMP, the following milestones
are identified:

  * MyPal ADULT and MyPal CHILD Study protocols are expected to be finalized on month 10 of the project (October, 2019) – they will include details about the data to be collected & their management and therefore they are expected to have significant impact on the DMP 

  

  * End of 1  st  reported period on month 18 is an update milestone for the DMP 

  

  * End 2  nd  reported period on month 36 is also defined as an update milestone for the DMP 

  

  * End of the project on month 42 is the final update milestone for the DMP 

  

#  Abbreviations

ALL: Acute Lymphoblastic Leukaemia

CERTH: Centre for Research and Technology Hellas

COPE: Committee on Publication Ethics

CTR: Clinical Trials Register

DMP: Data Management Plan

DOI: Document Object Identifier

DPO: Data Protection Officer

ERC: European Research Council

EU: European Union

FACT: Functional Assessment to Cancer Therapy

GB: Gigabyte

GDPR: General Data Protection Regulation

ICMJE: International Committee of Medical Journal Editors

ICT: Information and Communications Technology

IPR: Intellectual Property Rights

MB: Megabyte

ORDP: Open Research Data Pilot

OS: Observational Study

PRO: Patient Reported Outcomes

QoL: Quality of Live

RCT: Randomized Control Trial

RDF: Resource Description Framework

SRDR: Systematic Data Review Repository

WP: Work Package

#  Appendix A. Information Sheets  
  
<table>  
<tr>  
<th>

</th>  
<th>

**APPENDIX A – INFORMATION SHEETS**

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

ANNEX A.1

</td>  
<td>

ADULT PATIENTS Information Sheet

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

ANNEX A.2

</td>  
<td>

PARENTS Information Sheet

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

ANNEX A.3

</td>  
<td>

ADOLESCENTS 16-18 Information Sheet

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

ANNEX A.4

</td>  
<td>

HEALTHCARE PROFESSIONALS Information Sheet

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

ANNEX A.5

</td>  
<td>

FAMILY MEMBERS (HEALTHY ADULTS) Information Sheets

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

ANNEX A.6

</td>  
<td>

CHILDREN PATIENTS 10-15 Information Sheet

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

ANNEX A.7

</td>  
<td>

CHILDREN PATIENTS 6-9 Information Sheet

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