Patient Registry Data Requests

The Patient Registry is an invaluable tool for researchers conducting observational studies about people with CF in the U.S. About 50,000 individuals have been followed in the Registry since its inception in 1986; many of them have been included for over 20 years.

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Summary
  • Researchers who wish to request Registry data for observational studies can complete a formal application.
  • Requests for Patient Registry data undergo a thorough review for scientific merit to ensure that the information needed for the study is available within the Registry, and that the proposed study design and analyses will yield valid results.
  • If the application is approved, data are securely delivered to the researcher after all regulatory and legal requirements are met.

The CF Foundation Patient Registry is an invaluable tool for researchers who are interested in conducting observational studies about people with CF in the United States. About 50,000 individuals have been followed in the Registry, and many have been included for over 20 years. 

Researchers who wish to request Registry data for observational studies can complete the formal application, which includes:

To date, more than 100 projects using CF Foundation Patient Registry data have been approved. Through many manuscripts published in peer-reviewed journals, these projects have made significant contributions to our knowledge of the disease.

Project topics include:

  • Demographics.
  • Pulmonary, nutritional, and microbiological outcomes among individuals with CF.
  • Impact of treatments and therapies.

A list of ongoing and completed approved Patient Registry data requests is available for download. We encourage you to review these projects to foster collaboration and prevent duplication of efforts.

The formal application guidance document indicates the format of the applications, regulatory requirements, and other responsibilities for individuals receiving Registry data. Please note that we require the involvement of a CF Foundation-accredited care center director as a member of the project team.

We recently linked the CF Foundation Patient Registry with The Pediatric Health Information System (PHIS) database. Investigators at PHIS sites can request to use these linked data using the same application process described above. 

Requests for Patient Registry data undergo a thorough review for scientific merit to ensure that the information needed for the study is available within the Registry and that the proposed study design and analyses will yield valid results. This review is completed by members of the Patient Registry/Comparative Effectiveness Research Committee, comprised of CF clinicians and researchers working with CF Foundation staff.

Meeting these requirements allows the CF Foundation to maintain our obligation and commitment to protecting the privacy of people with CF who allow their information to be included in the Registry. This information is protected by the Health Insurance Portability and Accountability Act (HIPAA) and the informed consent that was signed by every Registry participant or their legal guardian through their CF Foundation-accredited care center. The CF Foundation is entrusted with this personal health information and is responsible for keeping that information private and secure. For this reason, we have a standard set of criteria that must be met by all individuals requesting to use Registry data. 

The request and review process can take at least three months once the application and variable list are submitted. If the application is approved, data are securely delivered to the researcher after all regulatory and legal requirements are met. 

Projects generally take up to three years to complete. Study investigators are required to submit annual progress reports and are encouraged to present their findings to the larger CF community at the annual North American Cystic Fibrosis Conference and through dissemination in peer-reviewed journals.

Questions? Please contact us at datarequests@cff.org.

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Topics
Patient Registry | Research
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Downloads
Guidelines for CFFPR Data Requests Download (PDF)
Application for CFFPR Data and Confidentiality Agreement Download (PDF)
Patient Registry Approved Projects Download (XLSX)
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