#  Introduction and aim

The ultimate goal of the GetReal Initiative is to drive the sustainable
adoption of tools, methodologies and best practices from IMI GetReal and
thereby increase the quality of real-world evidence (RWE) generation in drug
development and regulatory/Health Technology Assessment (HTA) processes across
Europe. In this way, the project is committed to maximizing the societal value
of public and private investments in the IMI GetReal project.

The GetReal Initiative Description of Action (DoA) includes a Data Management
Plan (DMP) as deliverables 3.13, 3.14 and 3.15, as part of WP3. Together with
the GetReal Initiative Consortium Agreement, the DMP provides a general
framework regarding data management, data protection, data ownership,
accessibility and sustainability requirements.

Overall, the DMP provides a description of the data management, regarding
generated research data, that will be applied during the GetReal Initiative
project including:

  * A description of the data repositories, who is able to access the data, and who owns the data. 

  

  * The main DMP elements for each of the studies contributing (or sharing data) to GetReal Initiative and its tools. 

  

  * The time period for which data will be stored 

  

  * The standards for data collection, validation evaluation. 

  

  * The possibilities of and conditions for sharing data. 

  

  * The implementation of data protection requirements. 

  

The DMP is an evolving documents, therefore, some aspects may updates and/or
updated in later versions of the documents. An updated version of the document
will be uploaded as deliverables 3.14 and 3.15 in M12 and M24 respectively.

In summary, the GetReal Initiative DMP gives guidance and provides an
oversight of general data management, while each study needs to provide
specific data management information including, but not limited to, data
capture systems, data analysis systems, data protection and data privacy
measures, including description of de-identification of data sets and access
rules. In cases where the research results are not open access a justification
needs to be provided.

The following descriptions regarding research data and personal data are used:

**Research data** 1

_Refers to information, in particular facts or numbers, collected to be
examined and considered as a basis for reasoning, discussion, or calculation.
In a research context, examples of data include statistics, results of
experiments, measurements, observations resulting from fieldwork, survey
results, interview recordings and images. The focus is on research data that
is available in digital form. Users can normally access, mine, exploit,
reproduce and disseminate openly accessible research data free of charge._

**Personal data** 2

_Personal data is any information that relates to an identified or
identifiable living individual. Different pieces of information, which
collected together can lead to the identification of a particular person, also
constitute personal data. Personal data that has been de-identified, encrypted
or pseudonymised but can be used to reidentify a person remains personal data
and falls within the scope of the law._

_Personal data that has been rendered anonymous in such a way that the
individual is not or no longer identifiable is _no longer_ considered personal
data. For data to be truly anonymised, the anonymisation must be irreversible.
_

#  General principles

This is the first version of the DMP for GetReal Initiative. The DMP is a
working document and will evolve during the course of the project. The
document will regularly be updated to reflect the project progress. Table 1
lists the deliverables related to the multiple versions of the DPM for GetReal
Initiative.

_Table 1 GetReal Initiative DMP deliverables_  
  
<table>  
<tr>  
<th>

**Deliverable no.***

</th>  
<th>

**Deliverable name**

</th>  
<th>

**WP no.**

</th>  
<th>

**Short name of lead participant**

</th>  
<th>

**Type**

</th>  
<th>

**Dissemination level**

</th>  
<th>

**Delivery date**

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

3.13

</td>  
<td>

Data Management

Plan (M6)

</td>  
<td>

3

</td>  
<td>

UMCU

</td>  
<td>

R

</td>  
<td>

PU

</td>  
<td>

November

2018

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

3.14

</td>  
<td>

Data Management

Plan (M12)

</td>  
<td>

3

</td>  
<td>

UMCU

</td>  
<td>

R

</td>  
<td>

PU

</td>  
<td>

June 2019

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

3.15

</td>  
<td>

Data Management

Plan (M24)

</td>  
<td>

3

</td>  
<td>

UMCU

</td>  
<td>

R

</td>  
<td>

PU

</td>  
<td>

May 2020

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

_DMP = Data Management Plan; WP = Work Package; R = Document, Report; PU =
public_

_*Accordingly to the Description of Action for GetReal Initiative, page 37_

The DMP follows the ‘FAIR data principle’, i.e. data should be findable,
accessible, interoperable and reusable  3  . The general principles on access
rules are defined in the GetReal Initiative Consortium Agreement (Section 8
Intellectual property – Access rights).

GetReal Initiative makes use of one information exchange platform, the GetReal
Initiative member area. The member area is an password secured web space were
consortium member can store and exchange reports and documents. The platform
is not meant to share patient research datasets. The member area is hosted by
UMCU, contact person: Florian van der Nolle ( _f.l.vandernolle-
raven@umcutrecht.nl_ ).

#  Overview of data types generated and collected in GetReal Initiative

The GetReal Initiative will generate and collect the following types of data:
user surveys, interview reports, usage data, website analytics, market data,
and recruitment data. No personal data will be transferred from/to a non-EU
country or international organisations. Interview report are most prone to
contain confidential information.

The individual research projects and their main researcher will ensure
appropriate data storage and protection. Therefore they are asked to complete
a small dataset specific DMP table, as described in this DMP (chapter 4). The
processes will be worked out and implemented between M6 and M24, in
collaboration between WP3 Project management and the main researchers.

A summary of the data generated in the project can be found in Table 2, this
table will be updated along the course of the project. All generated data is
expected to be useful for the GetReal Initiative project, especially for the
sustainability of the tools, methodologies and best practices generated in IMI
GetReal.

_Table 2 Summary of data generated in GetReal Initiative_  
  
<table>  
<tr>  
<th>

**Group**

</th>  
<th>

**Task**

</th>  
<th>

**Objective**

</th>  
<th>

**Design**

</th>  
<th>

**Format**

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

Task Force A

</td>  
<td>

1.2.3

</td>  
<td>

Evaluation and maximization of the value/use of the PragMagic tool

</td>  
<td>

User data

</td>  
<td>

Numerical + textual

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

Task Force A

</td>  
<td>

1.2.2

</td>  
<td>

Identify reasons for (not) conducting pragmatic trials, as well as describing
encountered challenges in the consideration, planning, conduct and evaluation
of pragmatic trials.

</td>  
<td>

Survey

</td>  
<td>

Textual

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

Task Force A

</td>  
<td>

1.2.2

</td>  
<td>

Substantiate results from surveys and provide more in-depth insights into
specific challenges and their possible solutions

</td>  
<td>

Interviews

</td>  
<td>

Multimedia + textual

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

Task Force B

</td>  
<td>

1.3.3/ 1.3.3

</td>  
<td>

Determine requirements for ADDIS uptake and implement/test improvements to the
ADDIS tool

</td>  
<td>

User data

</td>  
<td>

Numerical + textual

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

Task Force B

</td>  
<td>

1.3.3

</td>  
<td>

Determine requirements for ADDIS uptake

</td>  
<td>

Interviews

</td>  
<td>

Multimedia + textual

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

Work

Package 2

</td>  
<td>

2.1/2.3

</td>  
<td>

Conducting a market research and establishing the value of the GetReal brand
and the tools

</td>  
<td>

Interviews

</td>  
<td>

Multimedia + textual

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

Work

Package 3

</td>  
<td>

3.6

</td>  
<td>

Maintaining the public website

</td>  
<td>

User data

</td>  
<td>

Numerical + textual

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

#  Operational data management requirements for GetReal Initiative research
projects

All individual studies within the project will need to complete the study-
specific DMP table (Table 3). The table will be shared on the member area. The
data owners are responsible for the completion of the table. Thereafter, the
completed table shall be shared with the data management team in WP3. They
will review the table for completeness, compliance with the DMP and the CA.
Furthermore, the completed tables will be added to the annex of future
versions of the DMP.

The data owners of the respective dataset are responsible to comply with all
legal and ethical requirements for data collection, handling, protection and
storage. This includes adherence to regulations, guidelines such as (but not
limited to) the EU clinical trial directive 2001/20/EC, Good clinical practice
(GCP) and Good Pharmacoepidemiology Practice (GPP), as applicable.

_Table 3 study specific DMP table (adapted from the Data Management General
Guidance of the DMP Tool_ 4  _)_  
  
<table>  
<tr>  
<th>

**General Overview**

</th>  
<th>

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

**Title**

</td>  
<td>

_Name of the dataset or research project that produced it_

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

**Task**

</td>  
<td>

_GetReal Initiative task/subtask where dataset was generated_

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

**Data owner**

</td>  
<td>

_Name(s) and address(es) of the organizations or people who own the data_

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

**Start and end date**

</td>  
<td>

_Start and end date of the study_

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

**Methods**

</td>  
<td>

_Explain how data is generated and analysed, listing equipment and software
used_

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

**Type of data**

</td>  
<td>

_User data or Interview data;_

_Does the dataset contain personal data?_

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

**Processing**

</td>  
<td>

_How is the data altered or processed (e.g. normalized), including de-
identification procedures_

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

**Sources**

</td>  
<td>

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

**Source**

</td>  
<td>

_E.g. Citations to data derived from other sources, including details of where
the source data is held and how it was accessed._

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

**Funder**

</td>  
<td>

_Information regarding financial support such as research grants, or indicate
that the data owner funds the study._

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

**Content description**

</td>  
<td>

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

**Subject**

</td>  
<td>

_Describe the subjects or content of the data_

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

**Language**

</td>  
<td>

_All languages used in the dataset_

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

**Variable list and codebook**

</td>  
<td>

_List all variables in the data file_

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

**Data quality**

</td>  
<td>

_Description of data quality standards and procedures to assure data quality_

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

**Technical description**

</td>  
<td>

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

**File inventory**

</td>  
<td>

_Files associated with the project, including extensions_

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

**File formats**

</td>  
<td>

_Format of the files_

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

**File structure**

</td>  
<td>

_Organization of the data file(s)_

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

**Checksum** _(if applicable)_

</td>  
<td>

_A digest value computed of reach file that can be used to detect changes_

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

**Necessary software**

</td>  
<td>

_Names of any special-purpose software packages required to create, view,
analyse, or otherwise use the data_

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

**Access**

</td>  
<td>

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

**Rights**

</td>  
<td>

_Any known intellectual property rights, statutory rights, licenses, or
restrictions on use of the data_

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

**Access information**

</td>  
<td>

_Where and how your data can be accessed by other researchers_

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

**Data sharing**

</td>  
<td>

_Description of how data will be shared, including access procedures_

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

**Ethical and legal issues**

</td>  
<td>

_Description of any ethics and legal issues associated with the dataset, if
any_

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

**Archiving and preservation**

</td>  
<td>

_Description of how and to what extent long-term preservation of the data is
assured. This includes information on how this long-term preservation is
supported._

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

#  Sharing and secondary use of data generated within GetReal Initiative

The information collected from the completed study specific DMP tables will be
uploaded on the member area. This will enable easy identification of the
available datasets and their respective data owners by consortium members. The
data owners are responsible for appropriate findability outside the
consortium.

To achieve the objectives of GetReal Initiative, it is imperative to follow
the collaborative approach the partners agreed on when signing the consortium
agreement. This includes the necessity to share data from the individual
studies for the implementation of the project, while respecting data
protection and intellectual property of the partners’ work. For those
individual studies within the project that need to use data generated in
another task, the metadata will contain the data owner contact details to whom
a requester can reach out if they need to access the results.

All data that will be generated within the project will be made accessible for
verification and re-use for subsequent research in due time, taking into
account intellectual property rights. When third parties want to use the data
that was generated or collected as part of the GetReal Initiative project, the
consortium PMO office should be contacted via Florian van der Nolle (
_F.L.vanderNolle-Raven@umcutrecht.nl_ ). Giving access to external parties
will be considered by the Coordinating Team (CT) and the data owner. Decisions
are made on a case by case basis. A separate procedure for accessing
consortium data after the end of the project will be described in the final
version of the Data Management Plan (D3.15, M24).

#  Personal data

The collection, handling storage and exchange of personal data will be
conducted in a secure manner, through secure channels. In addition, this will
happen under the applicable international, IMI and national laws and
regulations. Only data of relevance for the proposed research will be
collected, no excess data will be stored. GetReal Initiative researchers
commit to the highest standers of data security and protection in order to
preserve the personal rights and interests of study participants. They will
adhere to the provisions set out in the:

  * Regulation (EU) 2016/679 - General Data Protection Regulation (GDPR)  5 

  

  * Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications)  6 

  

#  Ethical aspects

The partners of GetReal Initiative and the associated partners are required to
adhere to all relevant international, IMI, and national legislation and
guidelines relating to the conduct of studies. ‘Ethics requirements’ are set
out in more detail by Work package 4 in Deliverable 4.1-4.4.