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Research Projects - Applications
The European Cystic Fibrosis Society Patient Registry (ECFSPR) is a unique data source. With pseudonymised demographic and clinical data from more than 56,000 people with CF across nearly 50 countries within the WHO European Region and longitudinal data from 2008, the database reflects the natural heterogeneity of CF across Europe.
Data are collected in accordance with agreed inclusion criteria, definitions and coding standards and rigorously checked. This rich source of information on many aspects of CF is used to produce annual reports and is also available to support and foster scientific research.
We invite applications from researchers, industry representatives and pharmaceutical partners seeking to leverage these valuable data for scientific research purposes.
Application Process
Researchers interested in using ECFSPR data must complete the Research Project Application Form and submit it via email to: coordination@ecfregistry.eu
All applications will be subjected to review by the ECFSPR Scientific Committee. In addition, applications from industry and pharmaceuticals partners will also be evaluated by the ECFS Clinical Trials Network (CTN) Executive Committee (CTN Executive | European Cystic Fibrosis Society (ECFS)). Per the recommendations of the Scientific Committee, all members of the Steering Group (comprised of national representatives from the countries contributing data to the ECFSPR) will decide to approve or not the use of their country’s data for the research project. This decision will be final. For comprehensive details regarding the review procedure, please read the Code of Conduct.
Data Provision and Requirements
The ECFSPR provides aggregated (anonymised) data and in exceptional cases non-aggregated (pseudonymised) data, provided that members of the ECFSPR Scientific Committee collaborate on the project. The data are sent via secure file transfer protocols.
Researchers or research groups may apply for ECFSPR data for only one research project at a time.
Before submitting a new data request, a manuscript based on the previous project must be completed and ready for submission to a non-predatory peer-reviewed journal.
To ensure the responsible use and safeguarding of the ECFSPR data all applicants must adhere to the following agreement requirements:
Use of Data Agreement
All applicants are required to sign a Use of Data Agreement. By signing this agreement applicants confirm that:
- The data will be used only for the specific purpose stated in the application.
- The data will not be retained longer than necessary to fulfil that purpose.
Data Transfer Agreement (non-aggregated data)
Applicants requesting access to non-aggregated data must also sign a Data Transfer Agreement.
This agreement sets out the conditions for:
- Secure transfer and storage of data;
- Ensuring compliance with data protection regulations;
- Prevention of unauthorised sharing.
Applications from non-European countries must demonstrate compliance with an adequate level of data protection, as stipulated in Chapter V of the General Data Protection Regulation (Regulation (EU) 2016/679).
Country-Specific Requests
For applications that request country-specific data, the ECFSPR will consult with the relevant national representatives/centre directors to determine the preferred method of data extraction.
Fees
Data applications will be subject to a fee depending on the nature and source of the request.
Composition of the fee:
The ECFSPR charges a fee for reviewing the application, whether the request is approved or not. To promote and stimulate research in CF, the application review fee will be waived for researchers and research groups.
A. Academic researchers ECFS Members:
free of charge
B. Patient organisations:
free of charge
C. Independent researchers/research groups:
Handling fee:
Free of charge
Data extraction:
Free of charge
Data analysis:
€ 250.00 per hour (equal to the number of hours spent on the project for the analyses)
D. Industry:
Handling fee:
€ 5,000.00 If the initial application needs to be amended and resubmitted an additional € 250,00 will be charged;
Feasibility & data-extraction:
Min. €25,000.00, to be decided on a case by case basis;
Data analysis:
€250.00 per hour (equal to the number of hours spent on the analysis/es);
Overhead :
50% of the hours for data-analysis/es.
Publication Policy
To ensure transparency, scientific integrity, and appropriate recognition of contributors, the following publication policy applies to all approved research projects:
- All approved research projects are expected to result in publication in non-predatory peer-reviewed journals. The manuscript should be completed and submitted within one year of data receipt.
- If journal publication is not feasible the project outcomes should be submitted as an abstract to a scientific conference, preferably the annual ECFS Conference.
- Draft publications and abstracts intended for submission to journals or conferences must be reviewed and approved by the Scientific Committee in advance. Authors are required to submit their drafts to the Committee no later than 15 working days prior to journal submission or 10 working days prior to conference abstract submission.
- All publications must include an acknowledgement of the ECFSPR with a link to the list of the national representatives/centre directors of the presented data; For an updated list please contact: coordination@ecfsregistry.eu.
- All publications will be listed on the ECFSPR website.
- A copy of any publication must be forwarded to the ECFSPR Epidemiological Research Liaison Manager (coordination@ecfsregistry.eu).
Conflict of Interest
As part of the application process, all applicants are required to declare any potential conflicts of interest. This is essential to uphold the transparency, objectivity, and integrity of all research activities involving ECFSPR data.
What Constitutes a Conflict of Interest?
A conflict of interest includes, but is not limited to:
- Direct financial involvement;
- Indirect financial involvement (e.g., shareholding);
- Peer conflicts (e.g., direct academic or institutional competition, collaborations that could bias the review or interpretation of results);
- Personal relationships that may influence the conduct or reporting of the work.
Declaration Requirement
All applicants must disclose relevant conflicts of interest in their research project application. The ECFSPR Scientific Committee will review these declarations as part of the evaluation process.
Consequences of Non-Compliance
Failure to declare a conflict of interest—whether intentional or due to negligence—will result in exclusion from submitting applications to the ECFSPR for a period of one year.
Team
Panagiota Gkolia
Epidemiological Research Liaison Manager
Federico Ambrogi
Lead Statistician
Univeristy of Milan
Annalisa Orenti
Statistician
Univeristy of Milan
Simone Gambazza
Statistician
Univeristy of Milan
Arianna Adamoli
Statistician
Univeristy of Milan