Updated 06 December 2018
Guidelines for the ECFSPR
a. The guidelines of the ECFS Patient Registry (ECFSPR) are made according to the Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. The definitions according to chapter 1, article 2 are as follows:
i. Data subject: the individual CF patient
ii. Controller: the ECFS and the ECFS Patient Registry Steering Group.
iii. Processors: the software service provider, the steering committees of the national registries and the local centRes.
iv. Third party: any scientist or project manager applying for data access.
b. The ECFSPR is founded and run by the European Cystic Fibrosis Society (ECFS).
The aim of the registry is to gather data that is accurate (measured against an internationally agreed standard) and which can be used for patient benefit as defined in the consent.
In reaching this aim, the ECFSPR is:
i. To measure and compare epidemiological and clinical aspects of cystic fibrosis in the participating countries, thereby encouraging the identification of new standards of CF management.
ii. To provide data for epidemiological research and identify groups of patients potentially eligible for multi-centre trials.
d. The data collected will be restricted to include only data needed to fulfill these purposes.
e. Funding of the ECFSPR can be private or public. Private funding should be through the ECFS and must be unconditional regarding access to data. No demands or request for special data or access to data will be met.
f. The ECFS is responsible for the ECFSPR observing the EU Data Protection Law on data handling and storage, use of data, anonymity, security etc. The individual centres are responsible for the data being accurate and kept up to date (on a yearly basis). The individual centers are responsible for obtaining informed consent according to the specific national requirements.
g. After an individual country/centre decides to participate in the ECFSPR, they can later decide to withdraw their data, but not retroactively. Projects already approved by the ECFSPR scientific committee will have access to the data included in the ECFSPR at the date of the approval.
2. Responsibility for Data Storage
a. The ECFS is responsible for the use and storage of data delivered to the ECFSPR by the countries and centres. The ECFS is the data controller.
b. Storage of data at a software service provider is to be supervised by the ECFS. The service provider should be authorised for data storage by the national data protection agency of the country where the data are stored (must be an EU country).
c. Should the ECFSPR be closed for any reason, all data will be cleared. Each centre will be able to get an extract of their data before closure of the ECFSPR. Authorisation of storage and handling of such data will be the responsibility of the single centre.
3. Ownership of data
a. Each centre/country owns its own data and has the right to use them freely (as stated in the local consent form). Each centre/country should be able to have their data extracted directly from the ECFSPR.
b. Access to the total dataset of the ECFSPR is governed exclusively by the ECFS, following the guidelines below.
a. ECFS Registry Contributors Group
The Registry Contributors Group is defined as anyone who contributes or plans to contribute to the ECFS Patient Registry.
b. The Registry Steering Group
The composition of the Registry Steering Group:
- ECFS Patient Registry Director, Chairperson
- One national representative per country contributing to the ECFS Patient Registry (Individual Country Manager or representative of the National Registry or an elected individual representing centres from a country)
- 2 members appointed by Cystic Fibrosis Europe, the Federation of Patients’ organizations.
The above listed are the voting members.
The Registry Steering Group will be augmented by the following non-voting members:
- A statistical expert
- A data protection legal and ethics expert on an ad hoc basis
- Representatives from Non European Cystic Fibrosis Patient Registries
- The ECFS Patient Registry Executive Coordinator
- A representative from the ECFS Clinical Trials Network
- The “Trusted third party”: responsible for centre codes for anonymisation purposes
The ECFSPR Steering group will set the strategic direction and areas of priority of the ECFS Patient Registry.
Responsibilities of the Steering group:
a. Ensures project is aligned with general ECFS strategy.
b. Approves formal collaborations of ECFS Patient registry with external organizations.
c. Nominates individuals to serve on the Executive Committee to replace members rotating off
d. By a voting process, nominates the Registry Director, nomination subject to approval of ECFS Board
e. Ensures the project makes good use of assets.
f. Assists with resolving strategic level issues and risks.
g. Provides advice and guidance on business issues facing the project.
h. Uses influence and authority to assist the project in achieving its outcomes.
i. Reviews and approves final project deliverables.
All officers of the Registry Board are envisaged to have a 4-year tenure.
The Registry Board will meet once a year, in conjunction with the European CF Conference.
The Registry Board may create committees amongst its members to focus on specific aspects of the Registry.
The Registry Board will be chaired by the Director. The responsibilities of the Registry Director are as follows:
- Handling of meetings of the ECFSPR (agenda, materials, purpose, actively leading the meetings, follow-up)
- Annually reports to ECFS Board and Annual General Meeting (AGM)
- Assesses project progress and reports on project to ECFS Board
The ECFS Patient Registry Director is appointed by the ECFS Board, based on a nomination from the Registry Board. The tenure will be of 4 years. In the last year of tenure, the Director will train the new Director to the position. The ECFS Patient Registry Director is a co-opted member of the ECFS Board.
d. An Executive Committee (EC) of interested stakeholders will be assembled.
Responsibilities of the Executive Committee include the following:
- Implements the strategy and policies decided by the Registry Board.
- Implements the ECFS Board's overall recommendations for change.
- Proposes new strategy and policies to the Registry Board.
- Monitors the ECFS Patient Registry activities, the operation, and all activities where ECFS Patient Registry undertakes legal obligations.
- Reviews reports and budgets prepared by the ECFS Patient Registry Executive Coordinator and makes recommendations to the Registry Board.
- Prepare an annual strategic and financial report to be submitted to the registry board and subsequently to ECFS board for approval.
The Executive Committee is comprised of
- ECFS Patient Registry Director
- 3 Members of the Registry Board
- One representative of the patient associations nominated by CF Europe
- CTN representative (the CTN director)
The ECFS Executive Director is an Ex Officio member of the Executive committee (non-voting)
The ECFS Patient Registry Executive Coordinator (non-voting).
Members of the Executive Committee will be appointed for 3 years (except the Director who is appointed for 4 years) and on a rotational basis. In order to implement the rotation system, the members of the first Executive Committee will be appointed for either 2 years or 3 years.
The committee is accountable to the ECFS board.
The Executive Committee will hold teleconferences twice a month and the minutes will be circulated to the entire Registry Board.
The Patient Registry Executive Coordinator provides a central role for information exchange, project coordination, management of sensitive timelines and general administration.
e. Scientific Committee
All applications for data from the ECFS Patient Registry will be reviewed by the Scientific Committee continuously.
The Scientific Committee will be composed of 6 members:
- 2 elected members from the Registry Board
- One patient representative
- One legal expert
- One statistical expert
- The executive director
All data extracts are granted after application (online/email) only. Special applications exists for data requests through the Clinical Trials Network.
5. Projected Data analyses
a. The ECFS will publish an annual report with epidemiological presentation of core data.
i. The annual report will be on a European and country level.
ii. Individual Centre data will be accessible to the center’s director and to a national registry coordinator in the event that such a recognized organization exists for the country (by a number – known to each center only). Data extracts for individual centers are thus not subject to Scientific Committee approval.
iii. The annual report will be kept at the ECFS offices and will be accessible at the ECFS and ECFSPR home pages.
Data for epidemiological research
a. All data extracts are granted after written application only, according to a procedure outlined in the ECFSPR website (except data extracts for individual centers – see above 5 a ii). Any applications from third country (non-EU) must ensure an adequate level of protection (chapter IV, article 25.1), and must be approved by the Danish Data Protection agency before release of data.
b. All applications will be continually reviewed by the scientific committee (no deadlines). Applications should be answered within one month of reception.
c. The scientific committee members must approve all applications by majority.
d. Title of project and contact person of all approved applications will be published in the annual report.
e. Data extracts are paid by the applicants at a cost fee that will be determined by ECFR Patient Registry Executive committee.
f. All applications should be scientific projects headed by individual independent scientists.
g. All associations with private companies especially pharmaceutical companies should be disclosed in the application.
h. No private or public company or patient organization will be granted direct access to data.
a. Applications for data of individual patients (e.g. diabetic patients) will follow the same procedures as above.
b. Patients suited for multi-center trials will be identified on a centre-level. The local centre can then be informed of the trial. Patients can only be identified by the local centre, and must be contacted by their local physician.
c. Applications for feasibility studies as well as patient identification for clinical trials should be submitted via the Clinical Trials Network, following special procedures (link to CTN).
d. All projects approved should be published, in the least as an abstract at the ECFS conference. If this is not possible, the key results must be reported at the web page of the ECFSPR.
e. A copy of any publication must be forwarded to the steering committee.
f. The ECFSPR should be acknowledged in any publication, with a reference to the list below.
g. An updated list of the persons responsible for the ECFSPR at the individual centers/national registries should be available at the ECFS homepage for reference in published articles.
6. Patient Information
a. An English version of the patient information is made available to all participating centers/countries. Translation should be done on a national level. These guidelines should also be available to the patients in translated form.
b. In countries with an existing national registry special informed consent for the ECFSPR might not be required, but the individual centre and/or national registry is responsible for the EU Data Protection Law, as well as national data protection laws and/or ethical requirements to be observed. The ECFS recommends, that patients be informed specifically of the ECFSPR.
c. Informed consent forms must be stored at the individual centre.
d. The patient/guardian has the right to see his/hers/the child’s data within a reasonable time. This access will be managed and met at a centre level.
e. The individual centre is responsible for informing the national registry or the ECFSPR if a patient has withdrawn his/hers consent. Data concerning this patient should be immediately removed from the registry.
Hanne Vebert Olesen