RRP Patient
Registry
A Secure and Simple Way for RRP Patients and Caregivers to Advance Research and Treatment
A patient registry is a collection of standardized information about a group of patients who share a condition. The information may be used for a variety of purposes such as conducting natural history studies and supporting disease-specific clinical trial recruitment.
The RRP Patient Registry is sponsored by the Recurrent Respiratory Papillomatosis Foundation and hosted by the National Organization for Rare Disorders.
The Purpose of a Registry
Support the design of clinical trials that explore new rare disease treatments
Describe the people who have RRP and to better understand the variability and stages of RRP
Understand how RRP changes over a person’s lifetime
Learn about clinical practice patterns and variations over the course of treatment
Help to develop best practices, management guidelines, and recommendations so that clinicians can know how to give the best care to improve the quality of life and outcomes of people with RRP
Identify people with RRP who might be willing to take part in other research studies or clinical trials. You can choose whether you want to hear about these other studies.
Data We Collect
The RRP Patient Registry collects the following information:
Socio-demographics
Medical history and diagnostics
Treatment and disease progression
Management of care
Quality of life
A Natural History Study
A natural history study tracks the course of a disease over time. It includes people who have a specific medical condition or disease. It may also include those who are at risk of developing the condition/disease. This type of research identifies demographic, genetic, environmental, and other information that may be common within the disease and its outcomes. A natural history study can also show differences in symptoms and changes over time among people with the same disease. Natural history studies often aim to find unknown similarities within the disease population. They have many potential uses, such as developing best practices for patient care and recruiting for clinical trials. Researchers often collect natural history data through patient registries.
For Researchers
Our Patient Registry collects disease-specific natural history data about individuals with Recurrent Respiratory Papillomatosis (RRP), with the goal of improving the understanding of RRP and informing treatment development. Registry questionnaires were built from common data element standards and cover the following topics:
Socio-demographics
Medical history and diagnostics
Treatment and disease progression
Management of care
Quality of life
Clinical trial participation
We are interested in sharing our data with you! If you would like access to the RRPF RRP Patient Registry data for a research project, please contact our registry administrator at registry@rrpf.org for more information. Access to RRPF Patient Registry data is contingent upon project approval by the RRPF Patient Registry Advisory Board.
Institutional Review
An Institutional Review Board, for the purpose of protecting your/the Study Participant’s rights, has reviewed this registry. An Institutional Review Board is a group of people who are responsible for protecting the rights and welfare of people who participate in studies. For questions about your rights as a Study Participant in this Registry or to discuss other study-related concerns or complaints with someone who is not part of this Registry team, you may contact the North Star Review Board at https://learningirb.org/.
Data Security
The RRP Patient Registry follows strict government guidelines to protect patient information. Your data is encrypted immediately when sent from your browser to the NORD servers. The data is also kept encrypted in the NORD database. Communications between the registry platform application server and the database are also encrypted. As with any information provided electronically, there is a very small chance that privacy could be compromised. However, the registry and the security measures minimize the chance of this occurring.
RRP Patient Registry FAQs
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This registry is open to anyone with a diagnosis of Recurrent Respiratory Papillomatosis who meets the study inclusion criteria.
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There is no cost to the patient to join this registry.
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You will not be paid for the information you provide. By participating, you will provide valuable data that can help researchers and new drug development efforts that may lead to a cure for RRP.
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A registry on NORD’s IAMRARE platform will typically be open for at least five years. Participants will be asked to return periodically to update their information.
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The registry uses an online platform which allows participants to contribute data from anywhere in the world. Individuals from other countries who enter data into the registry should be aware that data and privacy laws are different in the U.S. from those in other countries. This U.S. based registry will protect data and privacy according to U.S. requirements.
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For individuals living outside the United States who choose to share information about themselves, the same protections for privacy and confidentiality are offered as in the United States. Residents of the European Union and Switzerland have additional particular rights related to personal information. This information is disclosed within the informed consent document. If an individual signs this document, they acknowledge that they are disclosing information that would otherwise be private. Privacy laws in an individual’s country may have different protections than those provided in the United States.
Registry participants who are residents of the European Union and Switzerland are entitled to:
Request to obtain access to and rectification or erasure of personal data;
Receive personal data in a portable, readily-accessible format;
Restrict or withdraw permission for the processing of personal information; and
Lodge a complaint with an appropriate supervisory authority.
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The study sponsor, Recurrent Respiratory Papillomatosis Foundation (RRPF), owns the study data. RRPF decides how and with whom to share the data. NORD staff will have access to the data for activities related to the support and maintenance of the Platform and will collect Platform-wide participation statistics. The specifics will be outlined in your informed consent.
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All data, including those with PHI, will be stored in a password protected secure server. Access to PHI will be limited to:
Approved members of the RRPF Patient Registry research team
NORD staff, in cases where technical support is needed and with the permission of registry staff
With agreement from the Sponsor, NORD may conduct IRB-approved, cross-disease research using registry data.
In all cases, your privacy will be protected. The Registry Advisory Board will evaluate all requests for data from researchers. Researchers will only be provided with the minimum data necessary to accomplish their research study goals. Data containing PHI will only be shared if the research cannot be done without it. The researchers will be required to sign a Confidentiality Agreement in which they promise to keep your information safe.
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NORD, an independent nonprofit, is leading the fight to improve the lives of rare disease patients and families. We do this by supporting the rare community, its people, and organizations. We work together to accelerate research, raise awareness, provide valuable information, and drive public policy that benefits the estimated 25-30 million Americans impacted by rare diseases.
Learn more about NORD at https://rarediseases.org/.