Frequently asked questions

During enrolment into the study, personal data about you will be entered into the computer. From these personal data an unique code name (pseudonym) is calculated, consisting of a series of 9 digits (see example below). The following personal data are used: first name, last name, birth name (surname), date of birth and gender.

Which data do I have to reveal apart from the registration data ?

During the course of the TTP Registry study, medical, molecular, and observational data related to hTTP will be entered (see Patient Information Sheet for more explanation).

The clinician treating you
The clinician treating you locally, who is also your contact person for the Hereditary TTP Registry, is the only person apart from you, who can link your pseudonym and personal details. After the initial registration, data entry and viewing by your treating clinician 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 may be a suitable candidate, or when new findings for the treatment get available.

The Hereditary TTP registry staff
The Hereditary TTP Registry staff can see your stored data and can contact the treating clinician anually for the follow-up data. They can only view and use pseudonymised (non-identifying) data entered on the TTP registry.

For the purpose of data control, the hTTP Registry staff or assigned monitors and auditors are allowed to check with clinicians treating you that the data entered into the database match 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 you.

Scientists
This only includes scientists who are involved in hereditary TTP research. The scientists have to apply to the Steering committee 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).

System administrators
In order to administrate and to safeguard the hTTP Registry central database, a small number of authorised system administrators can view pseudonymised data.

Other individuals and groups
Nobody other than the groups and individuals stated above can access or receive your data. This applies for both identifying and pseudonymised data.

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.

All data will remain stored up to 10 years after the project has ended. A complete deletion of data is impossible because the data is likely to 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 study was carried out in accordance with regulations, even years after the research was completed. Alternatively, complete anonymisation can be carried out in the following cases:

• If you withdraw from participation in the Hereditary TTP registry and request anonymisation of past data relating to the study.
• If you request complete anonymisation of your data.

Following anonymisation, there is no possibility of the data being linked to you.