NISR are currently running registries for Epidermolysis Bullosa, COVID-19, Alopecia Areata, and Eczema or Atopic Dermatitis, with others to follow.
A database of information which includes clinical details regarding maintenance and treatment of patients with a particular dermatological disease is extremely useful in improving the overall condition of patients and promoting research and publication in that disease area. By gathering relevant information regarding diagnosis and treatment of a specific patient population into one central repository, it is easier to devise best practice strategies and guidelines; and at the same time, monitor clinical management regimes.
The purpose of individual dermatology registries is broadly to achieve the objectives below. However, these should be discussed and prioritised by the registry governance group.
- To capture the demographics of the condition and report on this annually
- To support advocacy
- To promote patient involvement in research
- To better understand the needs of patients and those caring for them
- To bring the experience of patients, experts and outcomes of research together to make best practice more accessible to all.
- To identify unmet needs and adverse events
High-quality dermatology patient registries require considerable time to develop and produce meaningful data. Development time is influenced by registry complexity and regulatory hurdles that vary significantly institutionally.
Our focus is on the dermatology community and the people they care for, to support them to adopt a more cohesive approach to patient registry development and data sharing that can lead to myriad benefits. These include improved utilisation of limited resources, increased data interoperability, improved ability to rapidly collect meaningful data, and shortened response times to generate real-world evidence. NISR works to support the development of an international federation of patient registries to consolidate and operationalise the lessons learned by the dermatology community. (Wall et al. Clin. Dermatol. 2021) We believe rare diseases in particular can benefit by cooperation and data harmonisation with our international colleagues. Conditions which have smaller numbers need support to combine their data with that of other countries to increase the power of their data. We believe this federation would provide an enduring means of applying international knowledge to the maintenance and development of sustainable, coherent and impactful patient registries of benefit now and in the future.
We have a network of organisations and individuals working with us who can help you.
Research Link 1
Research Link 2
Research Link 3
How do we define our registries?
NISR registries are observational studies of dermatological conditions. They collect and analyze data in order to better understand peoples health conditions, general well being and the treatments they receive. Registries are long term studies, ideally they would run for many years gathering epidemiological data over generations.
Data Sharing Statement
The role of NISR is to collect and protect patient data. We do not own any of this data, but act as stewards for the patients who wish for their experiences to be studied. We will never sell patient data. We act as an interface between the data and researchers. Permission to use the data is only given to researchers who have met all of our legal, ethical and safety criteria and show a clear research purpose and output strategy for the results.
We do not collect data to generate a profit for NISR, our Board do not receive any financial benefit from volunteering to work for NISR.
We serve our registry participants by providing a standardized structure that protects their data at an international level and a disease specific oversight to promote research focuses on what will most benefit patients.
We expect that we may by approached by companies to assist them in linking with patients who have given their informed consent to participate in clinical trials, to be contacted for surveys or asses epidemiology of patients.
Data applications are open to all health researchers. Terms and conditions may vary depending on the source and size of the application.
All the registries listed in the Our Registries section are now open for data requests.
Researchers will have to apply to the registry scientific committee for access to any data for research purposes and then will only be granted access to a specific dataset. The request for data will be reviewed for approval by the Registry scientific committee according to a present list of criteria which allows for only data which has been consented for the purpose to be shared.
It is the responsibility of the applicant to obtain appropriate ethics committee approval for any research relating to the data supplied, and to submit this approval with the application.
Which data, how it will be analyzed, the predicted output and the communications plan must also be presented in the researchers application and will be reviewed by the scientific committee.
The release of data for marketing purposes will not permitted.
If the researcher is approved access to the data all transfers will be anonymized and only the minimum amount of data required by the researcher will be provided by NISR.
In the event that the application is approved, the applicant must agree to use the registry data in accordance with the following terms and conditions:
- Data shall be obtained and used only for the purpose(s) specified by the applicant, and shall not be processed in any manner incompatible with that purpose(s).
- Data requested shall be adequate, relevant and not excessive in relation to the purpose for which they are processed.
- Data processed for any purpose(s) shall not be kept for longer than necessary for that purpose(s). Upon the completion of data analyses, you must destroy the original and any duplicate data files and notify the registry committee of the same.
- The data applicant ensures that the data are stored in a secure manner and they abides by the requirements to ensure confidentiality of the data. Data must be kept secure from any potential abuse.
- Appropriate technical and organizational measures must be taken against unauthorized or unlawful data processing and against accidental data loss, destruction, or damage.
- Data transfer onto a portable device such as a laptop, USB stick, CD or disk must ensure that the data is encrypted, so that data remain safe, even if the portable device is lost or stolen.
- The data applicant ensures that data shall not be transmitted to another party or legal or natural person without the committee’s permission.
- The data applicant is liable for any damage-causing events (e.g. loss of data), transfer to other persons/parties/ companies etc.
- The registry committee reserves the right – without prior notification – to retract its permission for data use. Additionally, the registry committee reserves the right to take legal action against the data applicant for compensation in case of inappropriate use of data or in case of a data procession in any manner incompatible with the purpose(s), including their right to penal actions.
These Terms and Conditions may be ammended and updated by NISR.
All NISR registries are secure web-accessible electronic platforms that support highly secure data entry as well as reporting, sharing and anonymization of the registry dataset for the purposes of patient benefitting research.
All data is stored and processed in a European Tier 3 data centre that comply with ISO27001 security accreditation.
All data from the primary server is copied to the secondary server every night. Daily full backups are maintained for 14 days. Weekly full backups are maintained for 8 weeks. Monthly full backups are maintained for 12 months. Backups are tested regularly to check the quality of restoration. All backups are protected from unauthorised access, theft and tampering with IP address restriction, restricted user access and password authentication.
Approved data applications should lead to the publication of NISR data in peer-reviewed journals. Submission to a peer-reviewed journal should be aimed for within 2-3 years upon receipt of the data. If this is not possible, the approved data application should result in the publication of an abstract.
NISR should be acknowledged for the release and use of the data in any oral presentation, publication etc., of the data, with the text: “We would like to thank the National and International Skin Registry Solutions CLG (NISR) for providing access to patient data, the individual centers for allowing the use of data, the parents/guardians of children, and adults with (the studied condition) participating in the registry.”
Where NISR provides statistical services, the contribution of the statistician should be reflected in manuscript authorship listings, as per journal manuscript authorship criteria.
Prior to submission of manuscripts, abstracts or posters, a final draft should be sent to firstname.lastname@example.org for review by the scientific committee. A review period of 30 days is required for manuscripts, and abstracts/posters. This is to ensure verification that the interpretation and conclusions of the authors are accurate and consistent with the scientific objectives initially stated in the proposal.
A copy of any publication (also report, abstract, article, program, essay, dissertation etc.) resulting from use of data must be forwarded to the email@example.com, on notice of the acceptance by the journal or scientific organization, together with the details of the publication.
Should any intellectual property rights arise from the use of the data, NISR should be informed. The applicant and NISR will be required to enter into separate agreement on patents, copyright, disclosure and sharing of financial returns.