Data and samples access

Any researcher (French or foreign) can request access to the data and samples collected by OFSEP by submitting a research project. Projects are evaluated following the submission procedure described below.
Scientific Board sessions take place every two months (see dates below). Project’s documents must be sent to This email address is being protected from spambots. You need JavaScript enabled to view it., at least 3 weeks before the evaluation session:

Deadline for project submission Scientific Board session date
Monday, October 8th 2018 Tuesday, October 30th 2018
Monday, November 5th 2018 Tuesday, November 27th 2018
Monday, January 21st 2019 Tuesday, February 12th 2019
Monday, March 18th 2019 Tuesday, April 9th 2019
Friday, April 19th 2019 Tuesday, May 14th 2019

 

The clinical data, biological samples and MRIs are collected and supply the OFSEP cohort as long as the patients are receiving care from a neurologist participating in the OFSEP project. These neurologists follow patients from all regions of mainland France and Martinique (see participating centers).

Since 15 June 2013, the participant neurologists routinely collect OFSEP minimal form (OMF) data for all their consulting or hospitalized patients. This form includes a description of the patients, their disease and their care. Prior to this date, the collection of these data was not mandatory, but a large amount of such information is available, being useful to patient care. Biological samples and standardized MRIs are collected in addition to the clinical data.

Twice a year, the data are grouped to constitute the OFSEP common database and enable, in particular, the implementation of research projects.

Documents

 

The National Coordination Center (NCC) is responsible for the operational roll-out of the project. Its main missions concern the coordination of the activities related to the cohort and the management of research projects. In particular, the NCC has a manager for academic partnership and a manager for industrial partnerships, who are the priority contacts for anyone wanting to work with OFSEP.

  • OFSEP can conduct prospective studies (analysis of data to be collected after validation from the Steering Committee) or retrospective studies (analysis of data already collected when the project is validated by the Steering Committee). 
  • The projects may concern data that OFSEP collects as part of its routine activity (OFSEP minimal form for clinical data, biological samples of the OFSEP biological cohorts, OFSEP-format MRI).
  • However, the projects may also require specific data that is not part of the routine collection process. In this case, the terms of collection are defined jointly by OFSEP and the project leader.
  • The data analysis is carried out by the OFSEP NCC, since access to raw data is only possible in certain highly specific cases.

All projects must be evaluated by OFSEP to determine feasibility and scientific pertinence; a contract is drawn up for each project, setting out the rules of data property and budget aspects. 

How to access OFSEP data?

Whether you are from academia, industry or an institution (or elsewhere), you must submit a project request before being able to access the data.

 

1st step: letter of intent (brief description of the project)

A letter of intent must be sent to the NCC briefly describing the project (objectives, prospective or retrospective study, type of data required, etc.). You will then have to submit a detained request, unless it is impossible for OFSEP to fulfill your request.

Please send the letter of intent to this address: This email address is being protected from spambots. You need JavaScript enabled to view it.

The partnership manager (academic or industry) will contact you and be your priority contact throughout the duration of your project.  

Optional step: assistance from the NCC

The NCC can help you to prepare your project before submission to OFSEP's Scientific Board (SB). Its knowledge of the data and the pathology, the analysis methods and the participant network makes the NCC an ideal source of help to adapt your protocol, if necessary. The modifications proposed do not represent a commitment from the Scientific Board, but they do improve your chances of a favorable opinion.

2nd step: submission of the project using the specific form

3rd step: evaluations and decision

Project evaluation, which is based on the Scientific Board, is arranged every two months and takes place in three stages:

  • The NCC evaluates the technical and operational feasibility of the project, and the methodology aspects.
  • The Scientific Board evaluates the methodology and scientific pertinence, having consulted the NCC report and sought an opinion from internal or external assessors.
  • The OFSEP Steering Committee validates or invalidates project implementation via OFSEP on the basis of the opinions given by the SB and NCC.

4th step: drafting of contracts

This step defines the contractual framework, including aspects regarding intellectual property, budget (activity of the OFSEP participant centers, specific project team within the NCC, data management and analysis, drafting of reports, etc.), project calendar and deliverables to be provided.

5th step: project implementation

  • For a prospective study: the NCC provides a project team to ensure study monitoring (relations with the participant centers, relations with the sponsor, etc.)
  • For prospective and retrospective studies: the data are managed by the NCC data manager and analyzed by the NCC statistician (raw data can only be available in certain very specific circumstances)

6th step: scientific communication

Any scientific communication made as part of a project involving OFSEP data, must comply with the publication charter and be sent to the relevant partnership manager.

OFSEP also proposes partnership contracts to industrial parties, providing them with a regular inventory of the cohort and aggregate data on patients under treatment, respecting confidentiality rules, and enabling access to OFSEP data under preferential conditions. For further information, please contact the industrial partnership Manager.

 

Documents