FSR Clinical Data Registry

Request for Applications

The FSR Clinical Data Registry will collect data on at least 2,000 patients at approximately 10 clinical sites in the United States where they have established care within the last 2-4 years.

The Registry will systematically collect, store, and analyze health information from patients diagnosed with sarcoidosis, with the aim of improving understanding, management, and outcomes of the disease. The registry will serve as a resource for clinicians and researchers, with the objectives to:

Collect well-characterized baseline and prospective data on patients with complex sarcoidosis, including those with extra- pulmonary involvement, that can be used to better understand:

-Current practice patterns with respect to diagnosis and treatment
-Risk factors for disease, specific phenotypes, and disease progression
-Patient reported outcomes

Enable comparative outcomes and other natural history research for patients seen at registry specialist clinical sites

Click Here to Apply

The primary goals of the Registry include:

Define the spectrum of phenotypes in sarcoidosis

Describe treatment patterns in sarcoidosis

Describe outcomes related to sarcoidosis disease course

Document the prevalence of treatment side effects and disease manifestations

Clinical sites interested in participating in the FSR Clinical Data Registry must complete the Site Application form no later than April 22, 2026 for consideration.

Participation Eligibility Criteria:

- Willing to participate in the FSR Patient Registry where survey data will be collected
  - Have a diagnosis of sarcoidosis established by consensus criteria and confirmed by biopsy with exclusion of other potential known diagnoses
  - New to the clinic in past 2–4 years
  - Age 18 or older
  - Anticipated follow-up at participating site and willingness to consent to participation

Exclusion Criteria:
- Disease diagnoses that, in the opinion of the investigator, limits the interpretability of the analysis of sarcoidosis (i.e. malignancy, infection, or exposure-related diseases). These include severe comorbidities and/or overlapping diagnoses that are the primary drivers of clinical course and therapy (i.e., rheumatoid arthritis)
- Non-consent to data use and sharing
Key Outcomes

Outcomes of interest include clinical trajectory (progression, hospital-related outcomes, and mortality), new organ involvement, patient-reported outcomes, and treatment initiation and response.

Registry Clinical Sites – Request for Applications

The FSR Clinical Data Registry will collect data on at least 2,000 patients at clinical sites in the United States. Patients will be followed every six months from the time of consent through the lifetime of the Registry, unless the participant chooses to withdraw from the Registry.

Registry participation will require collecting informed consent from participants to provide permission to access the individual's electronic medical record at the study site and contact for additional related research opportunities; no non-standard clinical procedures or testing will be required. Clinical site staff will extract clinical data as part of routine clinical care in the management of sarcoidosis. These data will be entered into a web-based, electronic data capture platform. Sites will be compensated for participation and efforts required for patient recruitment and data capture, with an expectation of 40-50 participants enrolled in the first year.

Imaging studies collected for diagnosis or management of sarcoidosis will be de-identified and uploaded to a secure platform. The Foundation for Sarcoidosis Research will serve as the Registry Data Coordinating Center and will manage data entered into the data platforms by clinical sites.

Funding Support

Registry clinical sites will be provided with a $20,000 start-up grant to assist with coordinator support. Sites will be compensated at $200 per patient at enrollment (upon completion of their baseline data entry), and $100 per patient upon data entry for each annual longitudinal follow-up. Enrollment and data entry for 10 participants will be included in the $20,000 start-up grant and payments will begin at participant #11. Starting year 2, sites will be provided with an annual $10,000 site grant to cover study team effort towards data management and oversight. All compensation will be provided by the Foundation for Sarcoidosis Research and is expected to be used at the discretion of the PI to cover clinicians with dedicated time or support for data entry and oversight. Indirect costs are limited to 10% of the award.

Applicant Requirements

Eligible study sites seeking to apply must meet the following criteria:

Member of the FSR Global Sarcoidosis Clinic Alliance (GSCA)

Willing to utilize a Central IRB, follow regulatory compliance, and adhere to data quality standards

Multidisciplinary sarcoidosis clinic with notable patient volume and distribution of organ manifestations

Accomplished clinical research team with proven track record of success

Principal investigator should be an established sarcoidosis expert with demonstrated commitment to the field (e.g., significant publication history or funding recipient for sarcoidosis-related projects). Preference will be given to applications that include junior faculty in a Co-Investigator capacity to encourage specialization and engagement in sarcoidosis.
Principal Investigators must commit to serving on the Clinical Data Registry Steering Committee and participate in discussions on program management and data access requests. PIs will also be included in all publications utilizing Registry data.

Please enter all information as requested on the ProposalCentral application form.

Application Requirements

Institution details
Applicant/PI and Key Personnel information
1. Role, name for each (PI, Co-PI, Sub-I, Research Coordinator, Regulatory Coordinator, Data Coordinator)
2. For clinicians, please include specialty
What electronic medical record system does your institution use? (EPIC, Cerner, Meditech, other)
Clinical Research Accomplishments (2,000 characters maximum). Describe relevant successful, completed or ongoing data registries, health record extraction projects, or clinical research studies conducted at your institution by your research team (including both investigator-initiated and sponsor-initiated research)
Describe your institution’s environment where the study will be conducted, and specifically the team’s research readiness and capabilities
Describe the average volume of patients with sarcoidosis seen at your clinic in the past year, include both returning and new (2,000 characters maximum)
1. Include general distribution of organ manifestations and demographics
2. Provide justification of a reasonable estimate of how many patients the team would anticipate enrolling in year 1 of the program
Describe the multidisciplinary team at your clinic, methods of collaboration, and how this will enable your site to most effectively capture a diverse cohort of patients with sarcoidosis with multiple organ manifestations, phenotypes, and histories. Preference will be given to sites able to bring in a comprehensive number of Co-Investigators representing the variety of specialties involved in treating patients with sarcoidosis (2,000 characters maximum)
Review the general data elements here and comment on the feasibility of collection through coordinator-level record review or informatics support at your institution. Detail your plan to ensure appropriate data quality in compliance with the study protocol. (2,000 characters)
Confirmation of support from PI’s Department Chair (commitment to support faculty engaging in the FSR Clinical Data Registry; intent to work with FSR to identify a new PI if investigator should leave the institution)
Attachments
1. Biosketches for key personnel
2. Letters of support from key personnel

Review Process

Applications will be reviewed by FSR Registry leadership and designated reviewers using a standardized scoring process. Each section will be scored on a scale of 1 to 5, with 1 representing the highest score. Reviewers will assess how well each proposed site aligns with the goals, needs, and long-term success of the FSR Clinical Data Registry.

Recruitment and Retention Plan: Clinical site’s ability to recruit and retain a well-characterized cohort of patients with sarcoidosis. Factors considered will include the historical volume of new and returning sarcoidosis patients, diversity of organ manifestations and phenotypes seen at the site, and demonstrated strategies for sustained patient engagement over time. Applications should clearly justify anticipated enrollment estimates for Year 1 and describe clinic workflows that support longitudinal follow-up.

Principal Investigator And Key Research Team Qualifications: Expertise, experience, and readiness of the Principal Investigator (PI) and key study personnel to successfully conduct registry-based clinical research. Consideration will be given to demonstrated leadership in sarcoidosis care or research, prior experience with multicenter studies or data registries, and the overall strength and complementarity of the proposed research team. Preference may be given to applications that include mentorship or engagement of junior faculty in Co-Investigator roles and to individuals who contributed to the development or governance of the FSR Clinical Data Registry.

Clinic Infrastructure And Institutional Support: Whether the clinical and institutional infrastructure is sufficient to support high-quality registry participation. This includes availability of dedicated research staff (e.g., coordinators, data personnel), integration of research activities into clinical workflows, multidisciplinary collaboration across relevant specialties, and evidence of departmental or institutional commitment to supporting the PI and study team over the duration of registry participation.

Data Quality And Compliance Plan: Feasibility and robustness of the proposed data collection and quality assurance approach. Applications should demonstrate familiarity with the Registry data requirements, including the data dictionary, and describe plans for accurate, timely, and compliant data entry through medical record review or informatics-supported extraction.

Overall Site Engagement and Program Impact: Overall potential of the site to meaningfully contribute to the success of the FSR Clinical Data Registry.

Timeline

Applications open: February 2, 2026

Deadline for applications: April 22, 2026

Review period: April – May 2026

Awardee notification: June 2026

Questions? Please reach out to research@stopsarcoidosis.org