The Scientific Coordinator is responsible for the general coordination of OFSEP. He or she is in charge of collaborative relations with health care authorities, learned societies, the French National Research Agency (ANR) and industrials partners, representing the Project in face of third parties. The Scientific Coordinator might request the assistance of a member(s) of the Steering Committee or the National Coordination Center for this mission.
The Assistant Scientific Coordinator is appointed by the Steering Committee to co-chair the Strategic Scientific Board. He or she provides a complementary expertise to the Scientific Coordinator to define, implement and monitor the scientific objectives of the OFSEP Project.
The Executive Office of the Steering Committee prepares the files to be discussed during committee meetings, initiating discussions on the strategic orientations of OFSEP.
- Expertise and work on files with a strategic orientation for the project
- Follow-up of questions raised in Steering Committee meetings requiring more detailed investigation
- Discussion of ethical, legal and technical matters, as necessary
- Elaboration and advanced proof-reading of reference documents
- Miscellaneous proposals and recommendations
The Steering Committee has both decision-making and operational responsibilities: it defines the strategic orientations of OFSEP and appoints the people charged with monitoring their implementation.
The Steering Committee meets once a month. It may request the opinions of internal experts (particularly the members of the National Coordination Center) or external experts before coming to a decision.
- Routine project management
- Communication and publication of the decisions made and chosen orientations
- Appointment of work group managers
- Appointment of co-chairmen of the Scientific Board
- Coordination with OFSEP's EDMUS centers, BRCs (biological resource centers) and imaging centers
- Distribution of financial resources
- Analysis of recommendations from the Scientific Board and the work groups
- Relations with the health insurance fund, health care authorities and industrial players
The mission of the Strategic Scientific Board is to define the OFSEP scientific strategy as well as operational scientific objectives pertaining to this strategy (definition of inclusion criteria, data to collect, statistical analysis to carry out) in order to respond to major scientific orientations.
The Committee is composed of a maximum of twelve scientists (methodologists, epidemiologists, statisticians, etc.) and neurologists upon the proposal of the Steering Committee validated by the Scientific Coordinator and the Assistant Scientific Coordinator. It is co-chaired by the Scientific Coordinator and the Assistant Scientific Coordinator.
The Scientific Board is a consultative body.
It offers an opinion on the orientation proposals from the work groups (particularly on the type of minimal data and the minimal biological samples) as well as on the research projects and data access requests submitted to OFSEP.
The National Coordination Center (NCC) is responsible for the operational organization of the project. As such, National Coordination Center members participate in Steering Committee sessions to provide operational and technical opinions.
- Cohort operation
- Daily assistance for the centers in the collection of data (definition of collection and entry instructions, support, training, information, audits, etc.)
- Organization of the anonymization, centralization and management processes for the databases.
- Evaluation of OFSEP data quality, in collaboration with the work groups and the Scientific Board. Definition and publication of tools to improve data quality.
For these missions, the NCC has a project manager for each collection area (clinical, biology, imaging), who reports to the OFSEP Data and Tools Manager.
- Management of research projects (internal and external, academic and industrial)
- Evaluation of the feasibility and methodology of new research projects submitted to OFSEP.
- Assistance with project preparation: the Coordination Center can offer expert advice on the availability of data, data circuit and collection, statistical analysis plan, budgets, contracts, etc.
- Analysis of data and drafting of reports.
- Provision of raw data (in certain specific situations).
For these missions, the NCC has partnership managers (academic and industrial) who are main contact for project leaders. For each project, they are assisted by skilled team members (project managers, epidemiologists, statisticians, etc.).
- General coordination of OFSEP infrastructures
- Relationship management with participating centers in data collection
- Contracts and agreements management for industrial and academic collaborations
- Implementation and follow-up of quality procedures
- Development of human and financial resources of the project
- Communication and public relations
For these missions, the NCC has a Contract Manager, Coordination Technician and a Quality Advisor who report to the Resources Manager.
Three operational and scientific work groups provide expert advice on the collection of data and the operational aspects of what can be done with these data. These are the clinical, biology and imaging groups, each corresponding to the types of data collected.
The clinical group is coordinated by Prof. Jérôme DE SEZE (Strasbourg). The operational project manager of this group is Nadine DEBARD (Lyon).
- To define basic clinical data for all MS patients in the overall OFSEP cohort
- To define strategies to prioritize certain projects of interest
- To define strategies to implement monitoring of the quality of the data collected ("quality" sub-group)
IT tool: EDMUS software.
- To collect the data from the OFSEP form for each patient consultation or hospitalization, to ensure exhaustive, quality collection of the minimal data
- Collection of the following data: socio-demographic data, neurological episodes, clinical evaluations, irreversible disability, MRI and basic treatments
The biology group is coordinated by Prof. David LAPLAUD (Nantes). The operational project manager of this group is Guillaume BROCARD (Lyon).
- To define the basic biological samples of MS patients in the OFSEP cohort
- To define strategies to prioritize certain specific sub-populations
- To coordinate the actions of the participating BRCs (biological resource centers)
IT tool: Centralized base TK®.
- Mandatory biological samples (blood and urine) and optional biological samples (CSF, stools).
- Samples for the specific patient sub-groups (radiologically isolated syndrome, clinically isolated syndrome, Devic's syndrome, PPMS, PML and ADEM)
- Collection only in centers with an OFSEP BRC
The imaging group is coordinated by Prof. François COTTON (Lyon) and Prof. Vincent DOUSSET (Bordeaux). The operational project manager of this group is Stéphanie Lion (Lyon).
- Main objective: to integrate the MRI scans of all patients in the parent cohort (patients with minimal clinical data) and to collect more detailed MRI data for the nested cohorts
- To establish a common OFSEP imaging protocol (minimal sequences)
- To acquire, process and integrate the imaging data and their derivatives on a centralized imaging platform (Shanoir) to ensure interoperability with the EDMUS clinical database
- To run systematic quality checks on centralized MRI data
IT tool: Shanoir web platform and ShanoirUploader software.
- Minimal sequences installed directly on the machines by the leading MRI machine manufacturers, additional sequences proposed.
- At least one cerebral MRI every three years and one medulla MRI every six years, in the minimal format.
Alongside the work groups, two other transversal groups provide support services: legal group and communication group.
The legal group meets whenever a specific need is identified. It defines and drafts the legal documents for OFSEP (consent forms, charters, agreements, etc.).
The communication group was created in order to propose communication initiatives and to implement them in collaboration with the National Coordination Center.
The annual OFSEP convention brings together the various parties involved in OFSEP to review the previous year and decide upon the actions to be taken for the year to come. It offers an opportunity for work groups to get together physically for long periods, before reporting their progress proposals to all participants during the plenary session and enable their discussion. It also enables training of the clinical research associates (CRAs) working in the participating centers.
Attendance is by invitation from OFSEP. Registration is mandatory.
List of previous conventions:
- Thursday 14 - Friday 15 March 2019, LYON
- Thursday 8 - Friday 9 March 2018, LYON
- Thursday 16 - Friday 17 March 2017, LYON
- Thursday 17 - Friday 18 March 2016, LYON
- Thursday 12 - Friday 13 March 2015, LYON
- Thursday 13 - Friday 14 February 2014, LYON
- Thursday 7 - Friday 8 February 2013, LYON
- Thursday 9 - Friday 10 February 2012, LYON
The international Advisory Committee (IAC) provides an external point of view and offers scientific, ethical and strategic opinions on the actions and orientations of OFSEP.
It meets upon request from the Steering Committee when specific issues arise requiring its opinion, once a year, on average.
The Consortium Committee is composed of a representative of EDMUS Foundation, a representative of Lyon University Hospital and a representative of Claude Bernard Lyon 1 University. It is in charge of coordinating the perpetuation of the OFSEP, under the control of the Eugène Devic Edmus Foundation and to ensure the budget distribution.
It meets upon request from the Scientific Coordinator as needed.