#  Overview of data types generated and collected in BigData@Heart

A goal of BigData@Heart is to create a beyond-the-state-of-the art, open-acess
informatics platform that will bridge the available knowledge on AF, ACS and
HF, related comorbidities and current/emerging risk factors from observational
and experimental studies. In this platform, the BigData@Heart consortium will
combine a variety of resources such as biomedical knowledge, phenotyping
algorithms and informatics tools for exploring and analyzing heterogeneous
data from clinical, multi-omics and imaging sources.

To reach its ambitious goals, BigData@Heart will leverage national and
international research and innovation activities. BigData@Heart will exploit
the data from the various cohorts and registry studies described above.

Of note, certain specifications on the data sets provided by EFPIA partners
can only be provided after all confidentiality agreements (as part of the
grant agreement) are in place. Cohort and registry studies may include:

  * ACS, AF, HF disease-based genetic collections (e.g. GENIUS-CHD, HERMES,AFGen, EPICCVD, UCORBIO, Myomarks, CARDIoGRAMplusC4D, BiomarCaRE MORGAM, German young 

  

MI GS, SMART-NL)

  * Disease-based collections without omics (e.g. Nicor, ESC EORP HF Long Term, ESC EORP AF 

  

General LT, SwedeHF, SwedeHeart, Hamburg clinical cohorts, German young MI
study)

  * Hospital-based EHR data (e.g. HELIOS hospital group, UPOD, Farr Institute Scotland) 

  

  * Population based cohorts (e.g. CALIBER, ABUCASIS, Mondriaan) 

  

  * Population-based consented cohorts (e.g. ERFC) 

  

  * Healthy population cohorts with omics (e.g.INTERVAL, UCLEB, Blood donor cohorts, UK- 

  

Biobank, LRGP, EPIC-NL)

  * Trial Data (e.g. EAST - AFNET 4, AXAFA - AFNET 5 & 6) 

  

#  Operational data management requirements for BigData@Heart research
projects

Each research project (interviews, literature review, surveys, case studies,
etc.) needs to provide a short dataset-specific DMP, 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. If the research results cannot be open access a justification
needs to be provided.

##  Requirements for the short dataset specific DMP

All data owners need to fill in **Table 1** containing the meta data and
describing the data management of data sets. Metadata are specifications for
data that provide the contextual information required to understand those
data. Such specifications describe the structure, data elements,
interrelationships and other characteristics of data, the data repository
used, and need to be securely stored with the database.

These tables will be reviewed by the WP1 PMO team for completeness, compliance
with the DMP and compliance with the Consortium Agreement.

The completed descriptions for the subprojects (based on Table 1) will be kept
and maintained in Internal Workspace of the project and attached to the DMP as
Annexes as updated deliverable during the annual technical report.

**Table 1** Data requested per dataset

##  Sources

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

**Funded by** _Provide information regarding financial support such as
research grants, or indicate that the data owner funds the study._

##  Content Description

**Data description** _Keywords or phrases describing the dataset or content of
the data. Indicate version number if applicable. Describe the nature and
origin of the data._

**Language** _Describe languages used in the dataset._

**Variable list** _Give a short description of the variable. Describe:
variable name, length, and code lists._

**Data quality** _Please describe the applicable data quality standards,
procedures to assure data quality._

**Contact person** _Please indicate who should be contacted for detailed
explanation of e.g. file names, codes or abbreviations used in either the file
names or the variables in the data files._

##  Technical Description

**Repository** _Indicate where the data is stored._

**File** _Give a description of which files are stored, the data formats, and
file structure._ **inventory/formats/ description**

**Necessary software** _Indicate if specific software is needed_

##  Access

**Rights** _Please indicate which access rights are applicable according to
the data owner. Any known intellectual property rights, statutory rights,
licenses, or restrictions on use of the data._ **Access** _Please indicate how
the data can be accessed by other researchers, and what procedures exist._
**information**

**Sharing** _Please describe how the data can be share, what procedures are
relevant, if any embargo periods exist, and other information that is relevant
for data sharing. If the dataset cannot be shared or made open access, please
indicate the reasons._

**Archiving and** _Please describe how and to what extent long-term
preservation of the data is assured. This includes_ **preservation**
_information on how this long-term preservation is supported._

#  Responsibilities of the data owner

Data owners per task will be identified and described in Table 1/the Annexes,
which will be maintained. The data owner of the respective research projects
must ensure and is 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), Good Pharmacoepidemiology Practice
(GPP), as applicable.

#  Sharing and secondary use of BigData@Heart generated or collected data

##  Procedures for making data findable

With the overview of data owners and data repository used per task (Table 1)
available on the Internal Workspace and Annexes, the data owner can be
identified and contacted.

##  Re-use within the BigData@Heart consortium

For the success of BigData@Heart, it is critical that partners adhere to the
to the collaborative approach agreed in the consortium agreement. With the
overview of data owners and data repository used per task (Table 1) available
on the Internal Workspace and Annexes, the data owner can be identified and
contacted.

##  Re-use of BigData@Heart results by third parties

When third parties want to use data that was generated or collected as part of
the BigData@Heart project. The Consortium PMO office should be contact via
Linsey van Bennekom

(L.vanBennekom@umcutrecht.nl). Giving access to external parties will be
considered by Management Board and the Data Owner. Decision are made on a case
by case basis. The consortium strives for optimal access of third parties
during the course of the project, while keeping in mind the overall
objectives, goals and activities of the project consortium.

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.

#  Protection of personal data

Personal data will be stored in accordance with relevant national and
international legislation and good practice. Only those data will be collected
that are of relevance for the proposed research, no excess data will be
stored. Data will only be processed for BigData@Heart research purposes. For
all studies in this proposal all data will be coded and de-identified, and
where possible fully anonymised.

BigData@Heart involves further processing or secondary use of existing data,
as well as of data that are being collected currently or during the project.
To ensure patient privacy, all datasets for researchers include subject unique
identification numbers that enable feedback about one subject to the data
manager but do not enable identification of that particular subject.
Importantly, we will comply with the General Data Protection

Regulation: i.e. Regulation of the European Parliament and of the Council

(http://data.consilium.europa.eu/doc/document/ST- 15039-2015-INIT/en/pdf) on
the protection of individuals with regard to the processing of personal data
and on the free movement of such data that all organisations must comply with
during the project life time.

All research is conducted in compliance with applicable EU (e.g. Directive
95/46/EC of the European Parliament and of the Council of 24 October 1995) and
national legislation, which includes:

  * Compliance with the original study consent for which data were collected; 

  

  * Personally Identifiable Information (PII) is adequately protected; - Ensure that anonymisation/de-identification is conducted appropriately; - Ethical review is completed as required. 

  

In general terms, the appropriate data protection principles will be observed,
including:

  * Data are fairly and lawfully processed; 

  

  * Data are used only in ways that are compatible with the original consent; 

  

  * The amount of data collected is relevant and not excessive; 

  

  * All reasonable efforts are taken to ensure data accuracy; 

  

  * The data are used in accordance with the rights of the study participant; 

  

  * The data are stored securely; 

  

  * The relevant international and national guidance will be consulted. 

  

The EU General Data Protection Regulation (Regulation [EU] 2016/679, revising
Directive 95/46/EC on Data Protection and Privacy) will apply to the project
from May 2018 and is taken into account to ensure continuing compliance (as
described in WP7). New techniques developed within the project shall comply
with the general principles of the EU General Data Protection Regulation such
as the data minimisation and privacy by design. Proposals for data handling
during the project will be presented to the independent ethics advisor for
ethical assessment.

#  Ethical aspects

##  General ethical aspects

To achieve BigData@Heart’s goals, data derived from clinical care and studies
with human participants will be used. Throughout BigData@Heart, the aim will
be to attain high ethical standards in the conduct of research involving
humans and the collection, handling and storage of data. The study will adhere
to fundamental ethical principles of respect for human dignity (including the
principles of non-exploitation, nondiscrimination and non-
instrumentalisation), respect for individual autonomy (entailing the giving of
free and informed consent, and respect for privacy and confidentiality of
personal data) and the principle of beneficence with regard to the improvement
and protection of health. The consortium is aware of international regulation,
conventions and declarations and will properly address any other currently
unforeseen ethical issue that may be raised by the proposed research.

An extensive strategy to ensure potential ethical issues are dealt with
accordingly will be in place throughout the project and has a prominent role
in WP7. Ethics issues will be actively monitored throughout the project and if
new issues arise, the European Commission will be notified immediately.

  * provide expert support to the consortium in all relevant ethical questions 

  

  * ensure compliance with legislation and guidelines 

  

  * conduct regular project reviews 

  

  * issue recommendations to the consortium when appropriate 

  

Researchers are requested to have appropriate training regarding Good
Scientific, Good Clinical, Good Pharmacoepidemiology Practice Guidelines and
the legal and regulatory framework described in the following sections.

##  Studies using human data

For all studies that involved humans, approval of the local and national
ethics committees has been or will be sought. A portfolio of all relevant
documents such as ethical approvals, informed consent Forms, Information
sheets, and policy documents concerning recruitment, handling of incidental
findings, transfer of data and material etc. will be compiled. An analysis of
these documents will be performed – as part of WP7 – to create an overview of
current policies. This portfolio will be presented and discussed in the
Governance Committee (part of Task 7.3). In this committee, we will appoint an
independent Ethics Advisor. Any ethical issues arising from these documents
will be taken up by the partners from WP7.

Appropriate Informed consent from study participants has been and will be in
place prior to use of materials and prior to inclusion into the study.
Informed consent will be prepared according to EU standards and written in a
manner to enable laypersons to fully understand the aims of the studies, what
the study procedures are, which information will be used and for what purpose.
All potential participants will be informed about the relevance (with respect
to science and public health) and the content of the studies as well as about
the protection of their personal rights, data management and privacy. Copies
of the templates of Informed Consent and the ethical approvals which will
cover transfer of biological samples or personal data will be submitted to
IMI. Detailed information will be provided to the IMI on the procedures that
will be used for the recruitment of participants (e.g. number of participants,
inclusion/exclusion criteria, informed consent, direct/indirect incentives for
participation, the risks and benefits for the participants etc.). If
applicable, the applicants will demonstrate that human participants are
properly insured. All informed consent materials will be presented to the
independent Ethics Advisor for an ethical assessment.

##  Human Cells and tissues

Medical and ethical approval for the gathering and use of the human blood
samples – the blood samples that will be used for BigData@Heart are left-over
material from routine exams as well as planned sampling according to cohort or
trial specifics. In cases where additional sampling is necessary for data
enrichment (WP4), the subject needs to undergo only minimal additional
procedures in order for us to procure the blood sample. In addition, we will
have access to the related patient files through pseudomised procedures at the
relevant facility. The researchers involved in this project will not have
direct access to the patient’s identity but will obtain the required
information for their research. The material will be provided only if the
patient has signed an informed consent. The protocol, as well as the informed
consent will describe how we will deal with retraction of permission, no-
solicited findings, insurance, vulnerable subjects, and other ethically
sensitive issues. Specially trained hospital staff informs patients about
their voluntary consent and answers all possible questions in separate private
sessions with the patients. The rights, safety and welfare of the research
subjects override the interests of the study, society and science.

The infrastructure and management of blood sample collection and database
management of patient information has previously been established at all
relevant biobanks. All documents relevant to ethics approval, informed
consent, ethical study conduct, transfer of data, handling of incidental
findings etc. will be part of the portfolio of described under Task 8.2

In the case of human cells/tissues that are obtained within the project,
ethics approval will be provided to the IMI. In the case of human
cells/tissues that are obtained within another project, details on
cells/tissues type and authorisation by primary owner of data (including
references to ethics approval) will be provided to the IMI. In the case of
human cells/tissues stored in a biobank, details on cells/tissues type will be
provided, as well as details on the biobank and access to it.