#  Data summary

Whereas the HARMONIC project involves the collection and processing of
sensitive personal data on medical and radiological history (all data,
regardless of genetic, biometric and/or health data, are subject to medical
confidentiality and data protection), we will ensure that, whenever possible,
our data is Findable, Accessible, Interoperable and Reusable.

Protocols are developed for each of the four scientific WP (as shown in Figure
2 below):

**—** WP2: protocol to build the cohort of cancer patients

**—** WP3: protocol to build the cohort of cardiac patients

**—** WP4: dose reconstruction protocols (one protocol dedicated to each
cohort) **—** WP5: biology protocol

**FIGURE 2** : Organisation of the project

##  DATA PURPOSE

The HARMONIC project combines retrospective and prospective data collection in
two paediatric populations: paediatric patients treated with ionising
radiation for cancer or for cardiac defects. Data collection will be performed
in the participating hospitals after local, regional/national ethics approvals
are obtained. Our study will not affect treatment.

Data collected and processed within HARMONIC will be relevant and limited to
the purpose of the research project in accordance with the `data minimisation´
principle.

To fulfil the objectives of HARMONIC in _evaluating specific outcomes,
reconstructing_ _doses and investigating radiation-induced cellular responses
and biomarkers of_ _sensitivity_ , data collection will include:

**—** In WP2, extracting data from medical records and hospital databases such
as clinical outcomes, lab test results, specific prescriptions, collecting
data from electronic and paper records from the radiotherapy departments
(Treatment planning, DICOM RT data), obtaining neurovascular/MRI imaging and
cardiac echography data, collecting blood and saliva samples and interviewing
participants via questionnaires. Linkage with regional/national registries or
healthcare databases is anticipated.

**—** In WP3, collecting data from electronic and paper records from the
radiology and cardiology departments (DICOM data). Linkage with cancer,
mortality, other local/national registries and with health insurance databases
will be performed.

Retrospective data collection will be performed in all hospitals participating
in WP3 and three centers participating in WP2 (UZ Leuven (Belgium), Gustave
Roussy (France) and University Hospital Essen (Germany)). Linkage with
regional/national registries or healthcare databases will be done at the
national level, following the regulation in place in each participating
country. All personal identifiers necessary for linkage will be dissociated
with the link between the study ID and personal information stored in password
protects computer files either in the study centre or in appropriate authority
departments, depending on the country. Access to these files will be strictly
limited to authorised project personnel. Only pseudonymised data will be
included in the study database and transferred to participating centres for
processing and analysis

Prospective data collection is anticipated in all medical centres
participating in WP2 (KU Leuven (Belgium), DC Aarhus University hospital
(Denmark), Centre François Baclesse (France), Gustave Roussy (France),
University Hospital Essen (Germany)) and in at least two Italian cardiology
centres (Genova, Bergamo) of WP3.

Prospective data collection will be performed under informed consent signed
with the clinicians in the participating hospitals. For that, adapted
documents on the study description and procedures will be prepared to explain
the project to the participant and its legal representative and to guarantee
their comprehension. Material will be prepared specifically for the assent to
understand and consent to participation in the study.

Informed consent will include

**—** In WP2 and WP3, collection of human cells and tissues (blood and
saliva):

  * A safe amount of blood samples will be collected. 

  

  * Saliva collection is a non-invasive procedure; it is performed in dedicated tubes. 

  

**—** Specifically, in WP2, prolonged MRI acquisition of 7 to 14 minutes per
scan (but no additional MRI) resulting in minimal discomfort.

##  DATA TRANSFER

The HARMONIC project is collaborative by nature with main objective to pool
data and build European cohorts of pediatric patients. Transfer of data or
material between partners (or with linked third parties) is therefore
essential and will be performed after Data/Material Transfer Agreements are
signed. Templates of these agreements are included in the Consortium Agreement
and are provided in Annex-1 of this document. It is reminded that only
pseudonymised data will transferred, through secured servers, to the central
databases for analyses.

##  DATA COLLECTION

Data collection will be done independently for the two cohorts. For
preservation and longterm access, data collection will be accompanied with
proper documentation and associated metadata. Files will include the data
itself, documentation files with a description of how the data was collected,
and metadata that administer each behavioural task.

###  1\. CANCER PATIENTS

A detailed table of the cohort database is provided in Annex-2, with data
type, coding system and time point of collection (assuming prospective data
collection could be pursued in the last year of the project in parallel to
analyses). The database is structured with a core dataset including data which
should be available, for all patients, to allow building the cohort and
reconstruct doses (Task 4.2 in WP4). It also includes task-specific datasets
to performed WP2 tasks and subtasks on:

**—** Endocrine dysfunctions

**—** Cardiovascular diseases

**—** Neurovascular damages

**—** Second cancer

**—** QoL and societal impact

All data are classified in mandatory or optional as follows:

**—** Level I (Task 2.1, all centres): Mandatory for all patients

**—** Level II (Task 2.1, all centres): Optional for all patients / if
information is available **—** Level III

  * a) (Additional data, Tasks 2.2. to 2.6, in participating centres): Mandatory for patients included in the specific Task 

  

  * b) (Additional data, Tasks 2.2. to 2.6, in participating centres): Optional for patients included in the specific Task 

  

Optional information will be used to conduct specific sub-analyses within each
task.

The database of the project (HARMONIC-RT) will be developed at INSERM (partner
2): an experienced data manager (permanent staff) will be responsible for the
development of the CRFs, the setting-up of the database and supervising the
maintenance of this database. A budget has been secured to hire a data manager
(half-time for 4 years) to ensure the daily maintenance of the database and
data quality control. Beyond the resources directly allocated to the project,
INSERM can benefit from the support of its IT and data management permanent
staff, who is experienced to setting-up and maintaining databases for large-
scale epidemiological studies.

INSERM will develop the structure of the database and the CRFs, in close
collaboration with Essen and with the help of all investigators. An overview
of the circuit of data is provided in Figure 3 below. The CRFs and the
database will be developed by an experienced data manager. The use of RedCap (
_https://www.project-redcap.org/_ )  is currently investigated as potential
secure web application to build and manage the database.

A significant proportion of the included patients will come from Essen, which
already has a local registry. Automatically data transfer from this database
to the HARMONIC-RT centralized database will be explored.

Data collection will be performed in participating centres:

**—** Investigators from each participating centre will have access rights to
their own structured data at any time, but only to their own data except if
they contribute to a task group. Task group investigators should have access
to core data + taskspecific data that are provided by all centres contributing
to that task

**—** Linkage with external registries or databases (e.g. national cancer
registries, health insurance data) should be made at the centre or sponsor
level, because personal identifiers are needed for this purposes, and only
pseudonymized data will go to the centralized database

**—** Results of WP2, WP4 and WP5 tasks and subtasks (e.g. estimated radiation
doses, measured biomarkers) will be transferred to the centralized database

**FIGURE 3**

:

Overview of the circuit of data

_Reconstruction of doses and optimization_ (task 4.2 of WP4). Data mandatory
for dose reconstruction are height, weight and sex of the patient, DICOM files
including CT images and treatment planning data and delivered dose (see
Annex-2 Radiotherapy table). These data will be used together with
characteristics of the machine (beam commissioning data: Linac, Beam data and
detectors) to estimate doses to the main organs and structures (whether there
are in or out of the radiation field) (See Annex 3 for details). Pseudonymised
DICOM files will be transferred between treatment centre and partners involved
in dosimetry activities via a secured dedicated platform (several options are
being investigated considering technical specifications and compliance with
GDPR).

Contouring of the structures of interest will be provided by the clinical
centres to the dosimetry team (WPE, SCK●CEN, CEA and UZH) so that doses could
be estimated based on exiting analytical models, available phantom library and
Monte-Carlo simulation. A whole-body representation of the patient will be
created automatically by matching the patient structures acquired for
treatment planning through imaging with a computational human phantom.

Based on data collected for organ dose estimation, we will refine current
dosimetry systems and further develop and validate dosimetric tools, in
particular developing tools for estimation of dose in the clinic from
secondary neutrons in PBT, to provide the medical community with means to
improve real-time patient specific dosimetry, investigate the overall
radiation burden in radiotherapy patients, including contribution from CT
imaging for therapy planning and re-planning.

###  2\. CARDIAC PATIENTS

Individual epidemiological data for study subjects included in the study will
be collected by participating national centres. Database will be organised in
a similar way in all participating countries with a relational database
structure similar to the one presented in Annex-4. Data will be stored locally
and standards procedures will be implemented to send the data to centralized
database which will be localised at ISGlobal on a password protected SQL
server with restricted access to the data manager. The preferred mode of
transferring the data and the type of files will be defined in collaboration
with the responsible data base manager of national study centre. Each data
transfer should be accompanied by a description of the data: list of datasets,
number of rows in each file, the coding system used. The anticipated size of
the database (incl. dose data) is approximately 500Go. National data managers
will be in direct contact with data manager at ISGlobal, they will send data
samples to test data quality, validity and compatibility; feedback on the data
received will be provided. ISGlobal (following agreement with national
centres) will append national datasets into one international dataset and
transfer it to the centre responsible for the specific analysis task
(Statistical analyses) as defined in Annex I (Description of work) of the
Grant agreement. This will be done in close collaboration with national teams
and the centre responsible for specific analysis task, adjusting for the needs
of each specific data analyses task.

Basic data will be collected mainly from hospital electronic records
concerning the patient and cardiac procedure. Health insurance databases will
also be used where possible.

Basic data which will be transferred will include:

**—** Study ID (link with patient ID will remain at national level in a
password protected file with limited access to allow linkage with external
registries or databases (e.g.

national cancer registries, health insurance data)

**—** Name/code of the cardiology department

**—** Date of cardiac catheterisation,

**—** Machine type if available

**—** Name of procedure according to the classification built within the
project.

**—** Height and weight if available

**—** Dosimetric data: radiation dose structured reports (RDSRs) will be
obtained when available. The information from these RDSRs will be used to
estimate exposure parameters (see Annex 5).

Data on potential confounding will also be collected, where possible. It will
include data on transplant, confounding by indication/predisposing syndroms
and socio-economic status. Also, since these patients might have been
subjected to other types of medical (diagnostic) procedures, efforts will be
made to reconstruct, where possible, the personal radiological history of the
patients, including history of CT examinations.

_Reconstruction of doses and optimization (WP4)_

Detailed dose reconstructions will be performed for examinations in which
RDSRs can be obtained. The use of a dedicated software for data collection is
currently under investigation. The information from these RDSRs will be used
to estimate exposure parameters (beam angle, x-ray energy, etc.) for
examinations in which less detailed data were recorded. Dose estimation will
be performed using computer modelling which will be validated using physical
measurements in tissue-equivalent anthropomorphic phantoms.

Target organs for dose reconstruction will include breast (right and left),
bone marrow, brain, thyroid, heart, lens, oesophagus and lungs. Estimated
organ doses will be linked to the patient study ID.

Optimization of interventional procedures is difficult, as doses depend
largely on factors including difficulty of case, experience of operator, type
of procedure. Our data will provide a unique set of data on the trends in
radiation doses, patient characteristics and procedure types over time. This
information will be useful in the setting of indicationspecific diagnostic
reference levels (DRLs) for radiation protection purposes. The dosimetry
system developed during the project, linking organ doses to DAP or K  A,R  as
a function of a discrete set of variables, will be of use to hospitals and
researchers in radiation dose audits and dose reduction research.

To further contribute to optimization of doses in interventional cardiology,
we propose to develop, in collaboration with 2 to 3 pilot sites, an innovative
Augmented Reality (AR) Computer System that is able to support the operator
and assess the procedure. The operator will be supported with AR information
(wearing a dedicated headset) to increase image quality. The tool can then be
presented in dedicated training sessions to improve the realization of future
procedures.

###  3\. BIOMARKERS ANALYSES

All patients, radiotherapy and interventional radiotherapy will receive a
consent form and short invitation from wp2 and wp3 including the purpose and
aims of the research in a concise and clear manner. For each patient who
agreed to participate blood and saliva samples will be collected. Other
relevant patients’ data for biomarker and mechanistic studies include
demographics and treatment data: Age at first cancer diagnosis, sex, other
vascular and cardiotoxic treatment (e.g. cumulative doses of anthracyclines,
alkylating agents and other chemotherapy, including start date and end date),
radiation dose to different organ and substructures of interest performed by
WP4, follow-up data e.g., health events including; vascular and cardiac
damages, hypertension etc. Estimated doses of interest for WP5 activities are
doses to the heart, brain and large/middle vessels (mediastinal carotids,
willis polygon; cerebral arteries).

Blood and saliva samples from 300 patients will be collected in WP2 and WP3.
Blood will be collected at 3 time points: 1- Before start of
radiotherapy/interventional cardiology 2- day of finishing
radiotherapy/interventional cardiology or anytime up to three months after
finishing therapy 3- one year after finishing radiotherapy/interventional
cardiology.

Biological samples will receive a unique identification number prior to any
transfer of material (link between the ID of the patient and the code will be
kept at the collection centre in password protected files). Centralization of
material will be performed at SU (Sweden) where material will be sent in boxes
containing dried ice to keep the samples (blood, serum, plasma) frozen during
the transport.

The biomarkers which will be investigated are associated with changes induced
by radiation at the level of the transcriptome (miRNA), the proteome (plasma
and saliva protein profiling; and RPPA) and the epigenome (gene expression
regulation and protein modification) as well as inflammation and oxidative
stress levels (see Deliverable 5.1 for specific details)

##  DATABASE STRUCTURE VALIDATION

The CRFs will be reviewed against the database specifications documents as
well as the protocols to ensure the following:

**—** There is no duplication of data being collected.

**—** The forms are in the correct order.

**—** All associated code lists are correct.

**—** Data required for the statistical analysis have been included.

After completing the above, test data will be entered into the database to
ensure that all the specifications for each field have been programmed
correctly, including:

**—** Tab order of the fields.

**—** Sufficient field length.

**—** Entering of valid vs invalid data.

These checks ensure that when the database goes live, the data management
system works as expected.

Any changes that are required to the CRF during the study (assuming they are
approved by relevant ethical committees), will follow the above validation and
verification procedures before going into the production database.

##  DATA CLEANING

We assume that data will be checked and validated by providers. A list of
logical validation checks will be generated and shared with all contributing
centres (a list of basic checks is provided in Annex 6). The validations will
be performed at the level of the centre (or national level in WP3). Additional
validation and cleaning will be performed at entry in centralized database and
prior to analyses for specific tasks.

#  Data sharing

Intellectual property and data generated by this project will be managed in
agreement with the guidelines of EC and based on the Consortium Agreement and
Publication Policy. HARMONIC beneficiaries will disclose all inventions
developed within the project and such inventions will be reported and managed
according to the e.g. EC guidelines.

Integration and re-use of the data relies on the data being well organized and
adequately documented. The shared data are expected to be of interest to the
scientific and more specifically the radiation protection community, the
medical community and the general public. The type of data and tools to be
produced in HARMONIC include (but are not restricted to) background
demographic information, results from computational model simulations,
software….. Data and data products will be made available with as few
restrictions as possible. The publication of the research data or tools may
take place during the project or at the end of the project in accordance with
normal scientific practices.

Access to the project tools will be made available for educational, research
and non-profit purposes. This access may be provided via web-based
applications.

Research data documenting, supporting and validating research results will be
made available after the main findings of the final research dataset have been
accepted for publication. This research data will be processed to prevent the
disclosure of personal data. Reported study results will pertain to analyses
of aggregate data. No individual’s name will be associated with any published
or unpublished report of this study.

Results of the HARMONIC project will be disseminated mainly through open
access (free of charge online access for any user) peer-reviewed scientific
publications. Most beneficiaries have secured a budget for manuscript
publication.

Each beneficiary publishing results will:

**—** as soon as possible and at the latest on publication, deposit a machine-
readable electronic copy of the published version or final peer-reviewed
manuscript accepted for publication in a repository for scientific
publications; the repository of University Pompeu Fabra, Barcelona, is used by
the coordinator (ISGlobal);

**—** deposit at the same time, the research data needed to validate the
results presented in the deposited scientific publications and/or publish data
papers.

**—** deposit — via the repository — the bibliographic metadata that identify
the deposited publication

**—** The bibliographic metadata shall include all of the following:

  * the terms “Euratom” and “Euratom research and training programme 20142018”; 

  

  * the Health effects of cArdiac fluoRoscopy and MOderN radIotherapy in paediatriCs, HARMONIC and grant number 847707; 

  

  * the publication date, and length of embargo period if applicable, and 

  

  * a persistent identifier or digital object identifier (DOI) for the submitted data set(s). 

  

#  Ethical Requirements (POPD 4 & 5)

As described in Deliverable 1.1 - Ethics and Data Protection Requirements,
general procedures to be included in the research protocol to safeguard the
privacy of study subjects are:

**—** Pseudonymization will be implemented as a general standard meaning that
all material obtained in the framework of the project (questionnaires,
diagnostic images and imaging data, detailed information on treatment if
available) will be identified through a code, the name and/or other personal
data that could allow the identification of the participant will never be
indicated. This unique identifier will link all basic data required for the
study.

**—** The master key file linking the centre’s study numbers with personal
identifiers will be maintained in a password protected file with limited
access.

**—** All files containing personal data will be stored in encrypted and/or
passwordlocked files. Access to these files will be limited to authorized
project personnel;

**—** Written consent to use personal data will be obtained from the
participants consenting to be involved in specific parts of the project. The
contact details of the DPO will be made available to the participants.

**—** The patient will be free to withdraw his or her consent to the study at
any time

**—** Separate age-graded information and consent forms will be available for
minors/assents.

**—** If, according to the project requirements, it is necessary to transfer
personal data, participants will be properly informed in the consent form and
measures to ensure personal data protection will be implemented. Transfer of
anonymized data will be done according to the current legislation.

**—** Reported study results will pertain to analyses of aggregate data. No
individual’s name will be associated with any published or unpublished report
of this study.

**—** All project personnel will be trained in the importance of
confidentiality of individual records and required to sign a confidentiality
agreement.

**—** All data transfers will be completed using secured servers.

##  PSEUDONYMISATION TECHNIQUES

The codification of a study subject consists of a country code and a study
subject code. This entire code is called the “Study ID of study subject”
throughout this document. A Study ID should not be any number, such as social
security or health insurance number, which could allow the identification of
the subject.

Study ID of the study subjects are therefore created as a 9-digit number

**—** Country code (2-digit number)

**—** Study subject code (7-digit number)

As an example: the subject with national ID=5689 in the country coded as 13
would have the ID=130005689. Keeping the country code inside the ID allows
rapid grouping of subjects in analysis.

If the country code cannot be set for any raison, the code “99-unknown” will
be used. However, each patient should belong to specific national cohort.

Pseudonymisation of DICOM data will be performed under the following principle
_(1,2)_ to ensure that there are no reasonably likely means to identify the
patient from the use of this data:

**—** All DICOM tags associated with patient ID (example tag 0010,0020) will
be systematically replaced by Study ID or any other relevant general term.

**—** A code will be automatically generated (or Study ID will be entered) as
a new field.

**—** Where required for de-identification, date of birth (month/year to be
kept) and/or date of examination will be removed

**—** Link between Patient ID and code will be kept on a password protected
file in the centre providing data.

“To ascertain whether means are reasonably likely to be used to identify the
natural person, account should be taken of all objective factors, such as the
costs of and the amount of time required for identification, taking into
consideration the available technology at the time of the processing and
technological developments.”

##  TRANSFER OF DATA TO NON EU COUNTRIES

Transfer of pseudonymised data is anticipated from and to Switzerland (for
dose reconstruction purposes). The European Commission has recognised that
Switzerland is providing adequate protection (Adequacy decision). The effect
of such a decision is that personal data can flow from the EU (and Norway,
Liechtenstein and Iceland) to Switzerland without any further safeguard being
necessary. In others words, transfers to the country in question will be
assimilated to intra-EU transmissions of data.

#  Data security, storage and archiving

##  DATA SECURITY AND INTEGRITY

Data must never be sent via public networks or external wireless (including
email), and it should be encoded (or protected by any other encryption method)
that guarantees the information is not intelligible or manipulated by third
parties.

###  1\. CANCER PATIENTS

All data sent to INSERM is stored on the Institution’s server, within an
internal network duly protected to guarantee the integrity and security of the
information. Access is restricted to users with unique, personal and non-
transferrable authorisation.

The REDCAP application used at CESP for data collection is hosted on a
virtualized infrastructure (VMWARE). Access to the application is possible
from outside the CESP network, through a web proxy. The application is
protected by a double authentication (a first authentication at the level of
the proxy and a second at the level of the application itself). The
identifiers are different and nominative. Communication between the
application and the remote stations is encrypted with the implementation of
the https protocol.

In terms of network communications, security is provided by STORMSHIELD
firewall to ensure the filtering between the web proxy and the virtual server.
Daily backups are performed on disks, which are then outsourced on tapes
(fireproof box).

###  2\. CARDIAC PATIENTS

All data sent to ISGlobal is stored on the Institution’s server, within an
internal network duly protected by the _IT Resources Service_ to guarantee the
integrity and security of the information. Access is restricted to users with
unique, personal and non-transferrable authorisation. All information housed
on the ISGlobal servers is of a confidential nature. All the computer
equipment of the Institution is equipped with anti-virus software, connected
to a central database where all the virus definitions are up to date, and
there are periodically scheduled scans. Also, all the files coming from an
external source (usb devices, e-mail...) are scanned in real-time to avoid
accidental infections.

The data backup and storage infrastructure comprises six NAS server devices.
Of these, five are in the PRBB  1  data centre and are used to manage the
storage of all the institution’s data (administration and research projects)
and backup tasks corresponding to said data. A sixth Synology is located in a
nearby data centre, to have a physical device outside the main headquarters as
an external backup.

There are four kinds of backup copies with two levels (1-internal, 2-external)
to be able to restore the institution’s data and systems in different
scenarios (see below):

  * Internal backup of data 

  

  * Internal backup of Server 

  

  * External backup of data 

  

  * External backup of server 

  

The back-up strategy in place is meant to prevent accidental loss of data, to
allow reset of the service to its previous, fully functional status, in such
diverse situations as corruption of the operating system, configuration errors
or those caused by an IT attack, to restore all the centre’s data and data
infrastructure in the event of a critical incident at the institution’s data
centre.  
  
<table>  
<tr>  
<th>

</th>  
<th>

</th>  
<th>

**DATA**

</th>  
<th>

**SERVER**

</th>  
<th>

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

INTERNAL

</td>  
<td>

PROTOCOL

</td>  
<td>

Hyperbackup & Active Backup for Server

</td>  
<td>

Snapshots

</td>  
<td>

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

FREQUENCY

</td>  
<td>

daily

</td>  
<td>

3 times a week

</td>  
<td>

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

RETENTION

</td>  
<td>

30 days

</td>  
<td>

15 days

</td>  
<td>

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

EXTERNAL

</td>  
<td>

PROTOCOL

</td>  
<td>

Hyperbackup

</td>  
<td>

Hyperbackup Snapshots

</td>  
<td>

and

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

FREQUENCY

</td>  
<td>

Twice a week

</td>  
<td>

Twice a week

</td>  
<td>

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

RETENTION

</td>  
<td>

15 days

</td>  
<td>

15 days

</td>  
<td>

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

##  STORAGE AND ARCHIVING

Parties shall negotiate, toward the end of the project, an agreement to
provide guidance on future use of the databases including the following
provisions:

  * The access policy for the Parties, Affiliated entities to the databases 

  

  * The modalities for third parties to access databases 

  

  * The modalities to maintain the integrity of the datasets, the storage place for the databases and modalities to keep copies on remote storage 

  

  * The legal framework 

  

###  1\. CANCER PATIENTS

The HARMONIC-RT database is meant to initiate a pan-European registry of
particle beam therapy (and photon therapy at a later stage) in children and
adolescents. It is anticipated that toward the end of the project, agreements
will be signed for data to constitute such a sustainable registry. Complete
documentation for long-term data use and preservation will be provided.

###  2\. CARDIAC PATIENTS

ISGlobal Data Manager will follow ISGlobal guidelines to provide accurate and
complete documentation for data preservation. It will ensure that the data are
curated in a relevant long-term archive and ensure data will be available
after project funding has ended. We will create metadata for long-term data
preservation.

If no agreements are signed, the data will be returned to the providing
centre, in the format used for analysis and it will be destroyed from the
centralized database.

###  3\. BIOLOGICAL SAMPLES

Samples will be kept at 20°C for short-term storage (6 months) and -80 °C for
long-term storage. The plan is to analyse the samples within 6 months and the
left-over samples will be sent to the original centres upon request.
Otherwise, the samples will be decoded and used for new method development or
discarded after the results are published.