A key aspect of the project is the processing of my data in an exclusively pseudonymised manner. What does that mean and how is it carried out?
During your first visit,
your clinician will enter certain data about you into the computer. From these
personal data a unique code name (pseudonym) is calculated,
consisting of a series of 9 digits.
following personal data are used: first name, birth name (surname), date of
birth, place of birth and mother’s maiden name.
Mary Miller nee Smith, born 10.11.1964 in London,
mother’s maiden name Taylor.
This information generates the code (pseudonym
the pseudonym is created on the basis of a hash-algorithm. This is where an
explicit unique value is assigned during a complicated mathematical procedure.
The mathematical algorithm ensures that this can only take place in one
direction, i.e. the resulting value (the pseudonym) cannot be traced
back to your person by anybody (not even the system programmer).
Which data do I have to reveal apart from the registration data in the course of the Registry study and subsequent studies?
During the course of the
Registry study, some medical data will be recorded as well as your
personal details (see Participant Information Sheet for further details). If
you are participating in any subsequent studies, your clinician will give you
detailed information about the study and the data required for it accordingly. Each subsequent study requires separate patient consent.
Who can see and use my data?
If you wish, you can gain access rights with which you can call up your data.
If you don’t have access to your stored data, you can view the data stored
about you through the clinician treating you.
The clinician treating
The clinician treating you locally, who is also
your contact person with the European HD Network, is the only person apart from you
who can link your pseudonym and personal details.
After the initial registration, however, data entry and viewing by your
treating clinicians is carried out via the pseudonym assigned to your person.
Your clinician can use your personal information to contact you as and when
future studies arise for which you are a suitable candidate.
Euro-HD staff analyses your stored data in order to
investigators can only view and use pseudonymised (non-identifying) data
entered on the European HD Network.
- contact the treating
- co-ordinate projects and trials with the
For the purpose of data
control, investigators of the European HD Network (monitors and auditors)
are allowed to check with clinicians treating you that the data entered onto
the network matches with the data found in your medical records. Naturally,
monitors/auditors are bound by confidentiality during this, and no personal
data will be recorded outside the documentation belonging to clinicians treating
This only includes scientists who are involved in Huntington’s disease
research. The scientists have to apply to the Board of Directors (a group of
eight experienced clinicians and scientists) for authorisation to use the data.
These scientists can only view and use the pseudonymised data. They are
also required to ensure that any further use of the data and any publications
will be carried out in an anonymised form (i.e. not even using the pseudonym).
In order to administrate and to safeguard the Euro-HD Network central database,
a small number of authorised system administrators can view pseudonymised
Other individuals and
Nobody other than the groups and individuals stated above can access or receive
your data. This applies for both identifying and pseudonymised data.
What reassurance do I have that unauthorised individuals cannot gain access to my data via the internet?
During data entry, data processing is
encrypted. The server where the database
is stored is located behind a firewall. This sophisticated security system ensures that only authorised
computers and individuals can access the database. Furthermore, the central database holds no
record of your personal identity as it is pseudonymised.
How long is my data stored for?
All data will remain stored for the foreseeable
future. A complete deletion of data is impossible because the data is
have become part of a scientific study. The reason for this is because
the responsible researchers have to be able to prove that the relevant
carried out in accordance with regulations, even years after the
completed. Alternatively, complete
anonymisation can be carried out in the following cases:
- If you withdraw from participation in REGISTRY and request anonymisation of past data relating to that study.
- If you request complete anonymisation of your data.
Following anonymisation, there is no
possibility of the data being linked to you.