Patients
Explanation Registries
Our patient registries are databases that contain information about people diagnosed with rare endocrine or rare bone conditions.
We collect data on these rare endocrine and bone conditions to do research and improve the healthcare for our patients.
We have two different databases:
- e-REC an e-reporting tool that captures new clinical encounters. Your data might be shared in this registry, but only as an anonymous number. The clinician only writes down how many people they saw with a certain condition and you might be one of them. There is no way that number can lead back to you.
- Core Registry, that collects general information on all patients in the registry but also condition-specific in some cases. Your doctor will add your data to the registry only after you give your permission via an Informed Consent Form. In this form you can also tell us if and how you want your data to be shared.
Before you agree to share your information in our patient registries it is important that you understand what it is and what will be done with the information you provide. This page contains answers to some of the questions you might have. If you still have a question which is not in the Q&A section below, please ask your healthcare provider or contact us at registries@lumc.nl.
Frequently Asked Questions
Doctors share their knowledge, data and resources in virtual networks . Patient registries can gather data in a secure place and a uniform manner, which makes it possible to compare the information. With the data in our patient registries we can do research and are able to improve the health care for our patients with:
- shorter diagnosis time;
- homogenous treatment for patients (or expert care accessible to) in all European countries;
- better treatments and development of new treatments;
- improve quality of life of people affected by rare endocrine and bone conditions.
To evaluate if a medical, surgical, or behavioural intervention is effective you have to perform research studies, so called clinical trials. Some endocrine and bone/mineral conditions are so rare that only a few patients in the world will have the right profile for a clinical trial. It is very important that patients suitable for that trial can be found and contacted quickly.
The best way of ensuring this can happen is to make sure that patients’ details are all collected together in a single database, or ‘registry’, that contains all the information that researchers will need, including each patient’s particular condition and other key information about their condition.
The registries are intended as a public service for the benefit of patients living with rare endocrine and rare bone/mineral conditions. You will be informed of any new information relating to your condition which might be of interest to you – for example if better ways of caring for patients with your condition have been identified.
Benefits for you as patient:
- shorter diagnosis time;
- homogenous treatment for patients (or expert care accessible to) in all European countries;
- better treatments and development of new treatments;
- improve quality of life of people affected by rare endocrine and bone conditions.
The data collected can also provide benefits to other patients with your condition, for example by revealing statistics on how many people across the world have the same condition, or providing information for researchers interested in the best standards of care for your condition. Overall improving quality of life for people affected by rare endocrine and bone conditions.
All patients with a confirmed diagnosis (or pending diagnosis) of a rare endocrine or bone/mineral condition. It is possible to give your permission to your doctor to share your data in the database, without you actively participating in the database. If you would like to actively participate in the Core Registry, you can tell your doctor, who can invite you. Both patients and their caregivers or family members can participate in the registry to provide researchers with valuable data regarding a specific condition.
If you agree to have your data shared, you should read the Patient Information Sheet and sign the last page, the Informed Consent form. You can have your doctor share your data in the database, without you actively participating in the database. If you would like to actively participate, you can ask your doctor, who can invite you.
In case your doctor is not yet active in the registries, but you would like to share your data, you can send an e-mail to the Registry Team at registries@lumc.nl.
Your data will be stored securely and no unauthorized people will be able to gain access to any personal information about you. It is possible that your data will be used for research, but then your data will be as much anonymized as possible (e.g., your data of birth will be recoded in ‘child’ or ‘adult’).
When researchers would like to use data from the registries for research, they will have to put in an official request.
Your data will be kept for an indefinite period with an evaluation every 5 years under the responsibility of the coordinator of our registries. The Leiden University Medical Center (LUMC) is the current owner of the e-REC and the Core Registry platforms. The Core Registry and e-REC have been approved in the Netherlands by Science Committee of Internal Medicine at the Leiden University Medical Center as ‘research databases’. For further information please visit our page on ethics.
The data governance standards in the e-REC and the Core Registry comply with General Data Protection Regulation (GDPR). All information kept in our registries will be treated confidentially. If any research or other documents based on data from the registries is published, this research will never identify you by name.
Third parties wishing to have access to data (such as researchers or companies planning clinical trials or conducting research on new therapies) will only be given anonymous information. Before they are granted access to this anonymous information, they have to receive approval from our Data Access Committee. Your data will not be made available to employers, governmental organizations, insurance companies or educational institutions, nor to your spouse, other members of your family or your doctor.
If there is a change in your contact information, you can e-mail the Registry Team at registries@lumc.nl. Data regarding your condition will be updated by your clinician.
No, our registries will never pass on any personally identifiable data to anyone outside the registries. If a company asks to find patients who might be suitable for their trial, you will be sent a letter, giving you details about the trial and the name of the person to contact if you are interested (usually the doctor who is running the trial at the centre nearest you). But only when you have previously given us consent to contact you. That is the only legal way that patients can be recruited for trials, and we think it is also the best way, because you have time to consider whether it is something you are interested in without being put under any pressure.
We hope you will be interested in registering even if you don’t want to take part in a trial. Your information will still be useful to researchers who are trying to find out more about people living with your condition, and you will be provided with other information that might be relevant to your condition.
Your participation in our registries is completely voluntary. Our national data protection laws grant you the right to access your own data and to rectify it or withdraw it completely at any time. Should you wish to withdraw your data from our registries you will be free to do so without having to provide any explanation.
If you would like any additional information about our registries, please do not hesitate to contact us at registries@lumc.nl
