Management of this project will be undertaken by KUL and will follow a strict project management plan. This will ensure that all activities required are implemented accordingly, assess whether results and deliverables are attained at the milestones, be aware if there are obstacles or difficulties, which may prevent the project from delivering, and to assure the overall quality of the project implementation.
This will involve regular (TC) meeting with the different WP leaders, as well as with the dedicated IT personnel of DRE London and other subcontracted companies involved. Feedback will also be sought from the Registries Task force (ERN EpiCARE Research working group).
Per WP of the project, the project leader will control the achievement of each individual milestone and deliverable. We will try to anticipate major problems that could slow down the project.
WP1 will also guide the subcontracting procedures following standard EU guidelines. Before the grant proposal, we already collaborated with BIOMERIS and will subcontract this company for WP 4 and 5. As an attachment we provide the contract proposal. For other subcontracts, we prepared a document which stipulates the procedures we wish to follow. See extra attachment.

This will be combined with a strict financial control and possible adjustments of budget items.
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- To better disseminate that all stakeholders of EpiCARE (clinicians, researchers and representatives of patient associations) have already achieved a consensual agreement on what the epilepsy registry should contain as a priority and what should be the next targets for its development. One or more webinars will be developed explaining the choices made in developing the registry. All HCPs, members or affiliated partners of the ERN EpiCARE will be invited to participate at these webinars.
- To obtain support to the registry from all HCP administrations and national health care systems. Rationale will be developed centrally, to be used by medical and research teams at a HCP level when negotiating further development of local means, in both infrastructure and support for a regular contribution to the registry.
We are fully conscious of the fact that if local HCPs do not provide support to the medical teams in charge of the registry this may jeopardize the whole project as a result of lack of time to regularly enter data, particularly for small teams that do not dispose of the necessary man power to accomplish such tasks.
- Joint workshops between the team in charge of the development of the registry and the ERN EpiCARE WPs for the development of diagnostic tools and targeted therapies will be organized once a year. The aim will be to better synchronize actions for the development of high-quality clinical research projects using the facilities provided by the registry, projects that in return will contribute to the sustainability by providing the necessary funds.
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Progress of the project will be evaluated by a series of annual surveys focusing on:
- Number of full or affiliated HCP members of EpiCARE that with the financial support of their administrations have proceeded to the implementation of the technical and IT requirements of the registry and facilitated the interface between the locally used electronic files or databases and the EpiCARE registry;
- Evaluation of the medical time annually required per HCP to regularly inform the registry and type of support nationally or locally obtained for such tasks (reinforcement of medical and research assistant staff);
- Number of new patients introduced to the Registry by each HCP every year;
- Number of research projects per year developed with reference to the registry and received funding (either private or public);
- Future developments needed (external link with RD-NEXUS; link with patient association databases, etc) based on acquired experience from the use of the registry in practice.
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Further to the common dataset elements required, this WP will incorporate ontologies for EpiCARE-specific elements, integrated with the data capture instrument (REDCap). This will be required to ensure valid data entry for all forms We will need to prove/test data import function for spreadsheets, document the solution, determine basic reporting requirements and setup external REDCap instance at GOSH. We will then migrate existing REDCap project and data from UCL to GOSH, setup and configure as a multi-site project to include all EpiCARE centres and setup and configure all EpiCARE users and roles within REDCap to ensure data security/privacy for each site and appropriate role based access, updating instrument configuration as required
In cases where a large number of records are to be imported at once, there will be a case for adding data to a pre-defined spreadsheet that will allow bulk upload of records. This functionality is built in to REDCap, but will require validation to ensure that data are added correctly,
Along with the data model, the REDCap database will need to be accessible and configured for users at each site to be able to input data, but without compromising the security of the data already contained within the project (this will need to be maintained as users change at each of the sites)
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An extension of EPICARE REDCap registry will be designed and developed to enable EUPID pseudonym code generation from the REDCap user interface. The system will manage a unique pseudonym for each patient. Identifiable patient data will be provided to generate/retrieve the EUPID patient pseudonym. This data will not be stored inside REDCap.
Furthermore, local databases who want their data to be initially automatically included in the REDCap registry will be required to provide a table-like (e.g. Excel spreadsheet) export of their data, containing all the data necessary to generate the EUPID pseudonymization code and the data to be put in the EPICARE registry. Beside the data, centres will also provide description of the data.
Once the system is operable, 5 centres will pilot the registry entering 50 patients each. Regular teleconference meetings will be held with the project steering group and leader of this WP to ensure trouble shooting and correction of errors that may impede wider utilisation.
In order to be able to ensure transparency and multi-site data entry a real-time table will be developed that will be displayed on the website and give real-time information of the registry data entered per centre. The real time table will also summarise the data collected per rare epilepsy categories. A script will be developed in REDCap to ensure that data quality collated from all centres are maintained.
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A successful registry requires a strong team to work together throughout development of the registry. This includes a registry manager (with roles such as strategy, relations with the participating institutions’ administration, financial sustainability, and collaborations); a project manager (with roles such as timelines, milestones, deliverables, reports, communication and budgets); domain experts or disease clinical experts (with roles such as content of the registry, selecting appropriate disease variables, endpoints and scoring standards);); IT personnel (with roles such as information system architects, software developers, back office/helpdesk and bug resolutions, automation and output and ensure technical interoperability); Ethical, Legal and Social Issue (ELSI) and data specialists (with roles such as ensure compliance with legal requirements and data protection, informed consent); quality assurance experts (with roles such as data quality and quality assurance of procedures) etc.
This work package is aimed at developing an oversight structure (project management section 9) that will guide the development of the registry and ensure that is launched and securely used by all EpiCARE centres.
The registry steering committee will be formed supported by the EpiCARE steering committee and patient representatives. It will ensure that throughout the registry development process ethical, legal and social issues, along with legal requirements, including privacy, are addressed and the main international applicable ethical guidelines, soft regulations, and appropriate professional guidelines (e.g., WMA Helsinki declaration 2013, WMA Declaration of Taipei 2016, Cioms guidelines, Oviedo convention, The General Data Protection Regulation (GDPR)) are addressed.
Safeguarding patients’ data are based not only on privacy regulations, but also on informed consent and/or ad hoc national law for registries. Therefore, the registry steering committee will ensure that appropriate processes are in place to support our centres in 22 European countries to comply with national legislations. In terms of sustainability of the registry, the registry steering committee will ensure that the required budgets have been evaluated and that the registry is well resourced for a pre-defined period. For long-term sustainability the registry steering committee is planning to seek funding from multiple, complementary sources (such as other CHAFEA or EJP grants).
The project implementation group will oversee the development of SOPs and essential documents covering the topics of policy rules and governance; IT tools document; security document; ethic rules; manual training; instructions for database users; data elements/dictionary/standardisations; form templates (e.g., consent forms and patient information notice); auxiliary tables (such as participating centres, declared user list); classifications; quality assessment document containing all procedures, control mechanisms and methods for correct evaluation of the registry and their frequency.
The project core team will be managed from Great Ormond Street Hospital, London, where the REDCap registry will be hosted and its data will be stored. The team will ensure that it brings together all stakeholders.
As soon as the REDCap database is deployed, a training schedule should be in place to train REDCap users at every ERN centre whose responsibility will be to enter data or import data to REDCap.
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