Get started today at pwsregistry.org

The Global PWS Registry is a comprehensive and secure database, compliant with U.S. Health information privacy laws and FDA regulations. We invite you to register and participate today! Data from the registry can be used in de-identified aggregate form to help advance the understanding and treatment of PWS. The purpose of the Global PWS Registry is to

  • Document and increase understanding of the full range of PWS characteristics
  • Enable researchers to identify trends that generate new insights into PWS, and identify areas for additional study
  • Facilitate partnerships with university researchers and pharmaceutical companies
  • Guide the development of standards of care
  • Expedite the completion of PWS clinical trials
  • Allow participants to store their PWS medical data in one place
  • Accelerate solutions for PWS

You will be asked to provide details on topics such as as developmental milestones, scoliosis, medications, appetite, behavior and other aspects of PWS. Depending on your personal story,  the registry may take one or more hours to complete. However, you do not need to complete the entire registry in one sitting.

If you have any questions while completing the registry or encounter any challenges, please contact: info@pwsregistry.org

 

Get started today at pwsregistry.org

 


 

“The creation of this registry will allow families to document all of the medical, psychological, and behavioral issues their child may have over time, and to then have an open and complete dialogue with their physicians about these issues. Additionally, this will give families the opportunity to indicate their willingness to be contacted about possible research studies and researchers the possibility of having greater access to those families who wish to participate in research studies.” 

— Dr. Jennifer Miller, University of Florida


 

Get started today at pwsregistry.org

Our guide to “Getting Started in the Global PWS Registry” includes step by step instructions with visual screenshots.

Frequently Asked Questions

Q. Why should I join the registry?

The purpose of the Global PWS Registry is to collect and analyze PWS patient data to enhance the understanding of PWS. The Global PWS Registry is a critical tool to advance PWS research. The registry will:

  • Document and increase understanding of the full range of PWS characteristics
  • Enable researcher to identify trends that generate new insights into PWS, and identify areas for additional study
  • Facilitate partnerships with university researchers and pharmaceutical companies
  • Guide the development of standards of care
  • Expedite the completion of PWS clinical trials by helping to connect interested registry participants with clinical trials and other research studies for which they may be eligible
  • Allow participants to store their PWS medical data in one place
  • Accelerate solutions for PWS

 Q. Is my information secure?

The Global PWS Registry is hosted on the National Organization for Rare Disorders (NORD) “IAMRARE” Registry Platform. NORD’s Registry platform was developed with extensive input from experts at the National Institutes of Health, patient advocacy groups, and the FDA. The Global PWS Registry is a secure platform, compliant with:

  • US Health Information Privacy Laws (HIPPA, HITECH, and FISMA)  State privacy laws (where applicable)
  • FDA regulations on electronic records (21CFR Part 11) and
  • European Union Data Directive and General Data Protection Regulation

The Global PWS Registry guidelines and procedures have been reviewed and approved by an independent Institutional Review Board (IRB) (Hummingbird IRB). The purpose of the IRB is to ensure that human subject research is conducted in accordance with all federal, institutional, and ethical guidelines.

 Q. Who will be able to access my information?

The information you provide will be made anonymous (de-identified) and then aggregated (combined and summarized) with data from other registry participants. The Registry may share de-identified data with the PWS community, PWS groups, investigators and institutions conducting research studies or clinical trials, companies developing potential drugs or other treatments for PWS, or other parties. All data sharing is in accordance with the data access and sharing guidelines outlined in the IRB approved Registry protocol. Any information that identifies you will be removed. The only people with direct access to the Registry data are the co-investigators on the Registry protocol.

Q. I want to be involved in PWS clinical trials, how will I be contacted?

This registry will help match participants with potential clinical trials. If your profile matches the needs of an upcoming clinical trial, the Registry will notify you of the opportunity to participate and provide you with the contact information for the study coordinator. You will have the option to follow up with the study coordinator and determine if the study is the right fit for you.

Q. I completed the Registry last year, why am I being asked to complete the surveys again?

We ask Registry participants to update their data every year so that the database reflects the most current information on its patients. Our “Guide to Updating Your Surveys in the Global PWS Registry” provides step by step instructions with visual pictures.

Q. I’m in PWSA(USA)’s database, should I join the Global Registry, too ??

Yes! The PWSA(USA) database has been a valuable tool in helping the PWS community and researchers learn more about the frequency of symptoms and related issues in PWS. The Registry is designed to be a dynamic resource for the global PWS community. The Registry aims to be a Natural History Study, capturing the life experience of PWS from birth, through one’s entire life. Surveys can be updated as the person with PWS experiences changes in symptoms and life experiences. New questions can be added as the community identifies new research areas. The Global PWS Registry was developed based on the current standards for patient registries. The Registry questions, protocol, and data use policies have been reviewed and approved by an independent ethics committee called an Institutional Review Board (IRB), and the data is collected after participants provide ‘informed consent’. Data collected in this way can be fully utilized by university, government, and industry researchers (e.g. NIH, FDA) and published in major medical journals. The procedure for matching participants with clinical trials has been reviewed and approved by the IRB, facilitating patient recruitment. The Registry information is maintained in a secure manner, compliant with patient privacy laws.

Q. Where can I get additional information?

The Registry Protocol and Informed Consent documents, which detail how data is collected, stored and used, are available below. If you have additional questions, please email us at info@pwsregistry.org, or call the Registry Coordinator, Jessica Bohonowych, at (843) 302- 6295.

Q. How long will it take to fill out the registry?

The initial registration and general medical history will take 20-30 minutes to complete. After that process, the registry will lead you to a list of forms on different aspects of PWS (e.g., behavior, scoliosis, medications). Depending on how many complications the person with PWS has experienced, this section may take 30 mins – 2 hours to complete. We know that your time in very valuable and we appreciate your willingness to provide information so that the full spectrum of PWS characteristics can be determined. Entry of information into the registry does not have to be finished in one sitting – the data entered will be stored and can be completed at a later time, although we encourage you to complete the process as soon as you can.

Informed Consent

Protocol-for-Global-PWS-Registry

Get started today at pwsregistry.org