#  Introduction

This Data Management Plan (DMP) is created for the project CO-CREATE –
Confronting Obesity: Co-creating policy with youth. Project details:

  * Call: H2020-SFS-2016-2017 

  

  * Topic: SFS-39-2017 

  

  * Proposal number: 774210 

  

The consortium collaborating in CO-CREATE includes members from 14
institutions from 9 different countries. In order to appropriately respond to
the identified research questions, the project will re-use survey data from
other studies, and also collect data from three stakeholder groups; young
people (16-18 years old), scientific experts on adolescent obesity, and policy
makers and business leaders. The data types that will be collected include
system maps, interview data, and survey data. Moreover, system modelling maps
will be produced based on the system maps and existing research evidence, as
will benchmarking scores for policy effects on individual level behaviour.

  * This DMP contains the general principles for handling of each of the different data sources to be used in this project. 

  

  * Each partner is required to follow the principles outlined in this DMP, in protocols supporting the DMP, and in the signed Data Protection Agreement. 

  

  * Each partner is required to collect and store data in accordance with national law, and specific regulations of each partner institution. This also includes research ethics. 

  

  * The project will use a solution for secure processing of sensitive personal data called SAFE. SAFE is based on “Norwegian Code of conduct for information security in the health and care sector” (Normen) and ensures confidentiality, integrity, and availability are preserved when processing sensitive personal. Within this system the data will be anonymised before data are shared through open access. 

  

  * The data management centre at the University of Bergen will merge data from the different partners to build an international datafile for data analyses, document the data collected by each partner and openly share data according to details outlined below. 

  

  * In the first part, general administrative information about CO-CREATE will be presented, followed by a description of each data source. 

  

\-

#  1\. Administrative information

##  1.1 Project name

Confronting Obesity: Co-creating policy with youth (CO-CREATE)

##  1.2 Project Description

CO-CREATE aims to reduce childhood obesity and its co-morbidities by working
with adolescents to create, inform and disseminate evidence-based obesity
prevention policies. The project applies a systems approach to provide a
better understanding of how factors associated with obesity interact at
various levels. The project focuses on young people within the ages of 16-18
as the specific target group, a crucial age with increasing autonomy and the
next generation of adults, parents and policymakers, and thus important agents
for change. CO-CREATE aims to involve and empower young people themselves, as
well as youth organizations, to foster a participatory process of identifying
and formulating relevant policies, deliberating such options with other
private and public actors, promoting relevant policy agenda and tools and
strategies for implementation. CO-CREATE strengthens interdisciplinary
research, and it has an inclusive multi-actor approach with involvement of
academics, policy makers, civil society, relevant industry and market actors
to ensure long-lasting implementation of the results. The project has a strong
gender profile, and considers the relevance of geographic, socio-economic,
behavioural and cultural factors. CO-CREATE engages with international
partners from different policy-contexts in Europe, Australia, South Africa and
the US. Applying largescale datasets, policy monitoring tools, novel
analytical approaches and youth involvement will provide new efficient
strategies, tools and programs for promoting sustainable and healthy dietary
behaviours and lifestyles.

##  1.3 PI / Researcher (person, institution or organisation)

Coordinator (PI): Prof. Knut-Inge Klepp, Norwegian Institute of Public Health,
Norway. Phone:

004721078052 email: _knut-inge.klepp@fhi.no_ ORCID:
_https://orcid.org/0000-0002-3181-6841_

##  1.4 Participating researchers and/or organizations

Due to the size of the project, only the participant institutions and the
work-package leaders are listed below.

Participating Organisations:  
  
<table>  
<tr>  
<th>

No.

</th>  
<th>

Name

</th>  
<th>

Country

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

1

</td>  
<td>

Norwegian Institute of Public Health (NIPH)

</td>  
<td>

Norway

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

2

</td>  
<td>

University of Amsterdam (UvA)

</td>  
<td>

Netherlands

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

3

</td>  
<td>

University of Oslo (UiO)

</td>  
<td>

Norway

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

4

</td>  
<td>

World Obesity Federation (IASO-IOTF)

</td>  
<td>

UK

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

5

</td>  
<td>

London School of Hygiene & Tropical Medicine (LSHTM)

</td>  
<td>

UK

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

6 University of Cape Town (UCT)

</th>  
<th>

South Africa

</th>  
<th>

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

7 Centro de Estudos e Investigacao em Dinamicas Sociais e Saude (CEIDSS)

</td>  
<td>

Portugal

</td>  
<td>

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

8 World Cancer Research Fund International (WCRF)

</td>  
<td>

Belgium

</td>  
<td>

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

9 EAT

</td>  
<td>

Norway

</td>  
<td>

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

10 The University of Texas School of Public Health (UTHealth)

</td>  
<td>

USA

</td>  
<td>

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

11 Press (Press)

</td>  
<td>

Norway

</td>  
<td>

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

12 University of Bergen (UiB)

</td>  
<td>

Norway

</td>  
<td>

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

13 SWPS University of Social (SWPS University)

</td>  
<td>

Sciences and Humanities

</td>  
<td>

Poland

</td>  
<td>

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

14 Deakin University (DEAKIN)

</td>  
<td>

</td>  
<td>

Australia

</td>  
<td>

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

Work-package leaders:

</td>  
<td>

</td>  
<td>

</td>  
<td>

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

WP No.

</td>  
<td>

Name

</td>  
<td>

Name and E-mail

</td>  
<td>

</td>  
<td>

Org. No.

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

1

</td>  
<td>

Project management and coordination

</td>  
<td>

Therese Bakke _therese.bakke@fhi.no_

</td>  
<td>

1

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

2

</td>  
<td>

Policy assessment and monitoring

</td>  
<td>

Kate Oldridge Turner

_k.oldridge-turner@wcrf.org_

</td>  
<td>

8

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

3

</td>  
<td>

Obesity rates and energy balance related behavious

</td>  
<td>

Arnfinn Helleve

_Arnfinn.Helleve@fhi.no_

</td>  
<td>

1

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

4

</td>  
<td>

Obesity system mapping

</td>  
<td>

Cecile Knai

_Cecile.knai@lshtm.ac.uk_

</td>  
<td>

5

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

5

</td>  
<td>

Youth Alliances for

Overweight Prevention

Policies

</td>  
<td>

Christian Bröer

_c.broer@uva.nl_

</td>  
<td>

2

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

6

</td>  
<td>

Dialogue forum with representatives from policy and business

</td>  
<td>

Sudhvir Singh sudhvir _@eatforum.org_

</td>  
<td>

9

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

7

</td>  
<td>

Evaluation of CO-CREATEd

policy interventions and methodology

</td>  
<td>

Nanna Lien

_Nanna.lien@medisin.uio.no_

</td>  
<td>

3

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

8

</td>  
<td>

Open science and fair data management

</td>  
<td>

Oddrun Samdal

_Oddrun.samdal@uib.no_

</td>  
<td>

12

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

9

</td>  
<td>

Dissemination, exploitation and communication

</td>  
<td>

Hannah Brinsden

_hbrinsden@worldobesity.org_

</td>  
<td>

4

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

10 Ethics requirements Isabelle Budin-Ljøsne 1

_Isabelle.Budin.Ljosne@fhi.no_

##  1.5 Project Data Contacts

During the project, questions about the data or project should be addressed to
the Project Coordinator:  
  
<table>  
<tr>  
<th>

Name

</th>  
<th>

E-mail

</th>  
<th>

Org. No.

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

Knut-Inge Klepp

</td>  
<td>

_Knut-inge.klepp@fhi.no_

</td>  
<td>

1

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

Therese Bakke

</td>  
<td>

_Therese.bakke@fhi.no_

</td>  
<td>

1

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

After the project: When data is delivered to the data repository, questions
related to the data should be addressed to the PI and the leader of WP8:  
  
<table>  
<tr>  
<th>

Name

</th>  
<th>

E-mail

</th>  
<th>

Org. No.

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

Knut-Inge Klepp

</td>  
<td>

_Knut-inge.klepp@fhi.no_

</td>  
<td>

1

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

Oddrun Samdal

</td>  
<td>

Oddrun.samdal@uib.no

</td>  
<td>

12

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

##  1.6 Ownership of the material

As a general rule, results are owned by the party that generates them, with a
strong commitment to share the data for open use.

The physical activity framework and policy database that links to the healthy
diets framework and the policy database (NOURISHING), ref. WP2, D2.1 & D2.5,
shall be owned by World Cancer Research Fund International.

An interactive youth-focused website hosted by the World Obesity Federation,
including materials generated within the project, shall be owned by the World
Obesity Federation.

Further details in the CO-CREATE Consortium Agreement.

#  2\. Data Summary

##  2.1 Purpose of the data collection/generation and its relation to the
objectives of the project

By focusing on upstream factors and context change instead of individual
behaviour change, COCREATE will generate sustainable impacts that contribute
to narrowing inequalities in adolescent obesity. The project will i) evaluate
and also provide methodology of how to assess effectiveness of existing
policies on adolescent obesity, ii) provide knowledge base on what young
people, experts and policy makers find are important policy factors to address
when aiming to prevent adolescent obesity, and iii) provide a model that will
focus on how to involve young people and the range of relevant stakeholders by
explicitly politicizing the issue of obesity. This will be actualized by
providing specific obesity related policy proposals, and by designing and
testing advocacy tools and strategies for implementation and evaluation.

Figure 1 depicts the flow of data within the project and the transfer to the
public version of the data. All data will be collected and stored in a
safeguarded password protected system (see section 5 for details) to ensure
data protection. Safeguarded data include person details such as names and
contact details, but also indirectly identifiable data from notes. Only
anonymized data will be shared openly.

Figure 1: CO-CREATE Data management showing flow of data and data security
measures implemented as detailed in table

1 below and in accordance with the project Data Protection Agreement as
detailed in deliverable 10.3

##  2.2 The project objectives and how data collection/generation is connected
to them

  1. Provide methodology and evaluating existing policies 

  

  

To develop, test, and subsequently provide a valid, reliable, and easily
accessible and applicable methodology for monitoring and benchmarking policies
which directly or indirectly can influence energy balance related behaviours
(EBRB), no new data will be collected, but rather a benchmark of EBRB policies
will be generated based on existing data sources. Two sources of existing data
will be used; national policy documents addressing ERBR across the seven
European CO-CREATE countries, and data regarding individual level adolescent
ERBR and BMI measures. The individual level data will be re-used from the two
international surveys “Health Behaviour in School-aged Children. A WHO

Cross-national study” (HBSC) (www.hbsc.org) and the WHO European Childhood
Obesity Surveillance Initiative (COSI) ( _http://www.euro.who.int/en/health-
topics/diseaseprevention/nutrition/activities/who-european-childhood-obesity-
surveillance-initiative-cosi_ ), that both apply open access procedures to
their data. The benchmarking of each country’s policy will address its content
and effect on individual level behaviour in adolescents. The national policy
documents and the result of the benchmarking process will be made available on
the website of the World Cancer Research Fund International.

  2. Provide knowledge base 

  

  

The project will develop and deliver a set of visual system maps of policy-
dependent multi-level drivers of adolescent obesity across six countries
(Netherlands, Norway, Poland, Portugal, South

Africa, and the United Kingdom), and synthesize them into a single consensus
overview maps (WP4). For this purpose, both existing data from published
research as well a new data collected from mapping workshops with young people
and other stakeholders. Notes will be taken from the mapping workshops
involving discussions where the participants are asked to develop conceptual
maps of the drivers of positive energy balance through the food and physical
activity systems, informed by the existing evidence base. The conceptual maps
and the transcript of notes will be used to generate an overarching map
(system dynamic model) that depicts the key policy-amenable drivers of
adolescent obesity across Europe.

  3. Develop obesity related policy proposals 

  

  

In order to provide a model that will focus on how to involve young people and
the range of relevant stakeholders by explicitly politicizing the issue of
obesity the project will establish, make use of, and evaluate multi-actor
dialogue forums between public and private sector stakeholders (including
adolescents) that define and/or are influenced by obesity prevention policies
to work towards wider acceptance and support for effective obesity prevention
policies (WP6). The aim of the dialogue forums it to address and help refine
obesity prevention policies developed by youth, that policymakers and
businesses can respond to, based on engagement with youth to work towards
positioning youth as active agents of change and generating support for
effective obesity prevention policies. These policies and solutions will
accelerate the move from dialogue to implementation at a local, national and
regional level.

##  2.3 Types and formats of data that will be collected and generated by the
project

Three types of data will be collected in the CO-CREATE project: system maps,
interview data, and survey data. Based on the systems maps developed in the
mapping workshops and in combination with existing research evidence,
appropriate system modelling maps will be generated. Whilst building on
existing policy documents and existing survey data, benchmarking of national
policies will be generated. In section 2.4 the data protection measures
undertaken are presented in more detail.

System maps

System maps - in the form of causal loop diagrams – will be generated via
workshops, using a process called ‘group model building’ (GMB). Mapping
workshop participants will include adolescents from diverse socio-economic
backgrounds. The UK team will also host workshops for policy-makers and
academic experts working across Europe.

These system maps will represent the factors perceived by groups of
participants to affect the diets and physical activity of adolescents. In
addition to generating the maps, participants will discuss ways in which these
systems could be reshaped through policy actions in order to generate
healthier outcomes; this information will be captured via notes taken on paper
or digitally (laptop or tablet) but not attributed to any individual
participant. These notes will help in writing the reports, and in informing
the next steps (WP5 and WP6) but will not be otherwise qualitatively analysed.

Interview data

Following the youth alliance participation group and individual interviews
will take place in order to address the experience of the adolescents. These
interviews will be transcribed and coded.

Survey data

Adolescents participating in the youth alliances and other stakeholders
recruited to take part in the dialogue forums will be asked to fill in a
survey regarding their readiness for change and attitudes towards actions
preventing obesity. The youth alliance participants will be asked to fill in
the questionnaire prior to entering the alliance (baseline), and thereafter
regularly (monthly), with the final one three months after the stakeholder
forum. The survey to other stakeholders will be undertaken before, after and
three months after the dialogue forum. In order to describe the diversity of
the participants, the baseline questionnaire will also include data on date of
birth, gender, ethnicity, spoken language at home, their height and weight,
thoughts about their weight, socioeconomic status, physical activity habits,
and eating habits.

###  2.4 Data protection measures

Table 1 shows the data protection measures that will be undertaken for the
treatment of directly and indirectly identifiable personal data. Prior to
anonymization of data for the purpose of open access, all data will be
collected and stored in safeguarded password protected systems.

Table 1: Data protection measures in CO-CREATE during project period and post
project period, in accordance with roles of responsibility presented in figure
1.  
  
<table>  
<tr>  
<th>

Description of personal data collected

</th>  
<th>

Data protection measures implemented

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

</td>  
<td>

Delivery from data providers

</td>  
<td>

Level/privacy status

</td>  
<td>

Data protection measures

(responsible for fulfilment – see figure 1)

</td>  
<td>

Data management

and risk minimising measures within the project period

</td>  
<td>

Data

management

after project period

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

WP-4

</td>  
<td>

Participant name and contact information (e.g. phone number, email)

</td>  
<td>

Person level/directly identifiable

</td>  
<td>

Secure storage with access control

(1)

</td>  
<td>

Delete in accordance with project procedure

</td>  
<td>

N.A

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

</td>  
<td>

Systems maps

</td>  
<td>

Group level/anonymi sed

</td>  
<td>

N.A

</td>  
<td>

In line with ICF and in accordance with

obligations in GA 774210 and publication procedures

</td>  
<td>

Open access published results Provide as open access data

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

WP-5

</td>  
<td>

Participant name and contact information (e.g. phone number, email)

</td>  
<td>

Person level/directly identifiable

</td>  
<td>

Secure storage with access control

(1)

</td>  
<td>

Delete in accordance with project procedure

</td>  
<td>

N.A

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

</td>  
<td>

Notes from meetings

</td>  
<td>

Group level (indirectly identifiable)

</td>  
<td>

Secure storage with access control (1,2,3) Secure data delivery when
transferring

data (1,2,3)

</td>  
<td>

In line with ICF and in accordance with

obligations in GA 774210 and publication procedures

</td>  
<td>

Open access published results Secure fully anonymised data Provide as open
access data

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

</th>  
<th>

Alliance policy forms

</th>  
<th>

Group level indirectly identifiable)

</th>  
<th>

Secure storage with access control (1,2,3)

Secure data delivery when transferring data (1,2,3)

</th>  
<th>

In line with ICF and in accordance with

obligations in GA 774210 and publication procedures

</th>  
<th>

Open access published results Secure fully anonymised data Provide as open
access data

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

</td>  
<td>

Vlogs

</td>  
<td>

Person level/directly identifiable

</td>  
<td>

Separate follow up as part of Youth

Alliances (1) Provided channels controlled by the project partners (ref.

D9.1 version

1.2)

</td>  
<td>

In line with ICF and in accordance with

obligations in GA 774210 and publication

procedures

Separate follow up in information procedures

</td>  
<td>

Public access through platforms chosen by vlogger

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

WP-6

</td>  
<td>

Participant name and contact information (e.g. phone number, email)

</td>  
<td>

Person level/directly identifiable

</td>  
<td>

Secure storage with access control

(1)

</td>  
<td>

Delete in accordance with project procedure

</td>  
<td>

N.A

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

</td>  
<td>

Notes from forums

</td>  
<td>

Group level/ potentially indirectly identifiable

</td>  
<td>

Secure storage with access control (1,2,3) Secure data delivery when
transferring

data (1,2,3)

</td>  
<td>

In line with ICF and in accordance with

obligations in GA 774210 and publication

procedures

</td>  
<td>

Open access published

results

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

WP-7

</td>  
<td>

Participant name and contact information (e.g. phone

</td>  
<td>

Person level/directly identifiable

</td>  
<td>

Secure storage with access control

(1)

</td>  
<td>

Delete in accordance with project procedure

</td>  
<td>

N.A

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

</td>  
<td>

number, email)

</td>  
<td>

</td>  
<td>

</td>  
<td>

</td>  
<td>

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

</td>  
<td>

Questionnaire

</td>  
<td>

Person level/ indirectly identifiable

</td>  
<td>

Secure storage with access control

(1,2,3)

Personal identifiers replaced with code (1) Identifiable data and code key
stored separately with separate access control

(1)

Secure data delivery when transferring data (1,2,3)

</td>  
<td>

In line with ICF and in accordance with

obligations in GA 774210 and publication procedures

</td>  
<td>

Open access published results Secure fully anonymised data Provide as open
access data

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

##  2.5 Re-use of existing data

Existing data from two international surveys will be used: “Health Behaviour
in School-aged Children.

A WHO Cross-national study” (HBSC) (www.hbsc.org) and the WHO European
Childhood Obesity Surveillance Initiative (COSI) (
_http://www.euro.who.int/en/health-
topics/diseaseprevention/nutrition/activities/who-european-childhood-obesity-
surveillance-initiative-cosi_ ). Both surveys apply open access procedures to
their data.

The HBSC study has collected data on adolescent health behaviours in several
countries since 1981.

Currently there are 45 countries from across Europe and North-America involved
with the study.

Survey data collection is conducted every four years among a nationally
representative sample of 11, 13 and 15-year-olds. For the current project,
variables on height, weight, body perception, eating behaviours and physical
activity will be used. The 10th cycle of data collection took place 2017/2018.
A total of 200.000 students participate each survey year.

The COSI study has since 2007 collected nationally representative data on
objectively measured weight and height measurements among 6-9-year-olds. In
addition, the study collects information on school characteristics of
relevance for healthy eating and physical activity, and information from
parents on their child’s eating behaviours and physical activity. The fifth
round of data collection took place during the 2018–2019 school year. A total
of 300.000 children participate during each cycle.

Both studies follow standardised protocols for sampling, data collection and
data cleaning, as well as for translation of study items across the
participating countries, allowing cross-country comparison.

##  2.6 Expected size of the data

2.6.1 Collected data from adolescents

Approximately 600 adolescents will participate in different dialogue
activities organised across WP4-

7\.

The mapping workshops aiming to develop the system maps will take place in the
Netherlands, Norway, Poland, Portugal, the United Kingdom, and South Africa.
In each country, four schools will be selected and invited to host one mapping
workshop each. It is expected that a total of 24 workshops will be conducted.
Each workshop will aim to gather 10 to 15 adolescents. Thus, it is estimated
that about 360 adolescents will participate in the workshops led by WP4, where
60 adolescents per country (15 adolescents x 4 schools = 60) would be
recruited in six countries (60 x 6 = 360). From the 24 workshops, a similar
number of system maps is expected as a data outcome. In addition to these
system maps. The system maps, in combination with notes from the workshops and
existing evidence will be used to generate systems dynamics models visualizing
the relationships between the variables to determine the direction of
influence that increases or decreases adolescent ERBR and

obesity, and to illustrate balancing and reinforcing feedback loops. The
system dynamic models represent new data that can be used by others for
further research.

For the youth alliances a variety of recruitment strategies will be used,
including schools, youth organisations and peers. The aim is to recruit 40
adolescents in each of the six countries, establishing three alliances in each
country with 10-15 adolescents in each. In addition to these country-based
alliances, 40 adolescent students at the International school will be
recruited in the Netherlands to specifically address the EU level strategy in
an International Youth Alliance. In total, CO-CREATE will recruit
approximately 240 adolescents from six countries for participation in the
Youth Alliances, focus group and individual interviews.

2.6.2 Collected data from other stakeholders

About 30 experts and policymakers attending two different conferences will
participate in group model building workshops. Similarly, policy makers,
business leaders, and other stakeholders will participate in dialogue forums.
The exact group size for these group model building workshops and dialogue
forums are under development.

2.6.3 Re-use of existing data

For each of the surveys in the COSI study 300.000 children participate, whilst
200.000 adolescents participate in each HBSC study. As a starting point, data
from all surveys in the COSI study will be used, as well as HBSC data from the
2001 surveys and onwards. From 2001, major changes were made to the HBSC study
questionnaire as well as the introduction of new EBRB measures, hence data
after these changes were put into place will be used. By including data from
the last five surveys of the two studies, data from a total of 1.500.000
children and 1.000.000 adolescents across Europe and North America are
available for analyses.

##  2.7 Data utility

All data collected in the CO-CREATE project will be described and documented
to facilitate use of the data through open access.

The principal document for data description will be the protocol developed for
the different data collections. The protocol outlines the theoretical
framework for the data to be collected, translation with back-translation
procedures to ensure comparability of data and concepts used, recruitment
procedures (described in deliverable D10.1), coding procedures for qualitative
data and computing guidelines for quantitative data. Thus, the protocol
standardizes procedures to be followed by all countries and for all activities
taking place in the project, and conclusively will be a vital document for
everyone wanting to use the data collected in the project.

Guidelines will be developed for information from each mapping workshop, and
interviews after participation in youth alliances and dialogue forums. These
files will be documented and stored safely (including names of files etc.).
Moreover, procedures for how countries should transcribe focus group
interviews and individual interviews will be provided.

For the quantitative survey data a codebook has been developed providing
variable names and labels, values and labels. The University of Oslo
(organisation no 3) is responsible for undertaking the survey data collection
for all involved partners. They will be using a safeguarded password protected
system called TSD for this purpose. Clear procedures on how to ensure that
confidentiality is secured during data collections processes (including
storage of codes connecting longitudinal data) are with this system in place,
as well as instructions on how to ensure anonymity of data submitted to the
data management centre, placed at the University of Bergen (organisation no
12).

Guidelines will be developed for how each country will need to document their
data and in which format the data should be delivered, and how each file
should be named. Documentation of the data relates to concrete description of
recruitment procedures undertaken (e.g. number of invitations sent, number of
responses received, final number of participants), any deviations from
protocol (e.g. recruitment, data collection (procedures, instruments), any
coding procedures used (e.g. for qualitative data).

Based on the documentation of the data and the data itself, each file will be
checked for consistency with protocol and guidelines. Agreed cleaning
procedures to secure comparability of the data across the participating
countries will be performed by the data management centre. National files that
have been cleaned will be merged into international datafiles both for the
qualitative and quantitative data for use in the project as well as by
external users.

#  3\. FAIR data

The project will adopt the FAIR principles of making data findable,
accessible, interoperable and re-usable.

##  3.1 Making data findable, including provisions for metadata

The data from the project will be made easily available on a data website. A
Digital Object Identifier (DOI) system will be developed and used when
publishing findings using the data for easy access to both check and further
use the data. Our metadata will be in the form of an Atlas.ti documents. Our
naming convention will follow a certain uniform agreement, such as: type of
data-country-pic-date taken-version. Example: fgd-poland-zofia-170819-v1. A
set of key words will be developed to identify the datafiles from the CO-
CREATE project.

Use of data is vital to identify any errors in the data. Additionally, the
data will provide basis for standardising derived variables. To document such
changes made to the international data files it is important to have clean and
concise version numbers of the data file, as well as documentation of changes
undertaken from one version to the next.

Metadata providing information on overall protocol for recruitment procedures,
sample, data collections guidelines and instruments, deviations from protocol,
and any coding of data undertaken will be presented. The metadata will be
provided along with the data.

##  3.2 Making data openly accessible

All data collected in the project will be anonymised, and will after cleaning
be shared through open access as soon as the data has undergone the cleaning
procedures and international quality assurance procedures. The quality
assurance process will need internal use of the data between 6-9 months to
allow identification of errors in data that have not been discovered through
the cleaning process, and that typically are better observed when analysing
the data. The data will be made available through an open access data
deposition repository. The decision on which open access data deposition
repository to use has not yet been made, but some relevant options have been
identified.

We are looking into two options for access, either accessible for direct
download or with a request for a name and email address to keep track of those
interested in the data and that data is not used for commercial purposes. If
the latter approach is chosen, we will ensure that storage of person
information is undertaken in alignment with the regulations for the General
Data Protection Regulation (GDPR).

The qualitative metadata, namely the qualitative coding and the analysis,
might be accessed through Atlas.ti in which different data will be organized
in different categories, such as data type, locality, participants and other
relevant emerging categories. Atlas.ti offers an XML exchange format for
future data stewardship and is part of the the QDA-XML Exchange Standard (REFI
on _http://www.qdasoftware.org_ ).

The quantitative data will be made available as SPSS files, but can also be
exported as excel files.

##  3.3 Making data interoperable

In the protocol for the CO-CREATE project we will identify approaches and
variables used in other studies, so that data can be connected across studies.
When appropriate, international standard coding systems will be used (ISO
coding), I.e. for country codes and socio-economic codes. The project will aim
to connect its data with other projects and make the CO-CREATE data available
for other projects to connect to.

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

The data will be made available as soon as it has been checked for errors and
documented properly. There will be no licences required to access the data.

#  4\. Allocation of resources

The project has included resources for data management as part of its budget.
That involves resources to prepare the data for open access as well as to
manage the future maintenance of the data. The data management centre is
situated at the University of Bergen and will aim to maintain access to the
data also after the project period, or make sure to deposit the data to a
repository that will maintain access to the data.

#  5\. Data security

The University of Bergen (organisation no 12) has a strong fire wall security
and safety related to storage of data. A copy of all the original data will
therefore be kept safe and provide basis for data recovery should the online
platform fail.

The project will use a solution for secure processing of sensitive personal
data called SAFE. SAFE is based on “Norwegian Code of conduct for information
security in the health and care sector” (Normen) and ensures confidentiality,
integrity, and availability are preserved when processing sensitive personal
date. SAFE uses a 2-factor authentication, and each user will have to supply a
onetime code received on their phone. This process demands for each user to be
set up to use SAFE via the University of Bergen and WP8, ensuring no
unauthorized access is possible. All researchers requiring access to SAFE will
be guided by WP8, to ensure correct installation and usage. A similar data
collection and data storage system (TSD) has been developed by the University
of Oslo (organisation no 3), and this system will be used for safeguarded data
collection of the survey data.

Dats will be anynomised before transfer to the SAFE system at the University
of Bergen (see table 1).

#  6\. Ethical aspects

Emphasis will be given to secure confidentiality during data collection and
anonymity when data are shared. Informed consent is sought from all
participants with regard to the data and information collected in the project,
including approval to open access sharing of the data.