Patient information and signature of the consent form

Conform to regulations, the CNIL (French data protection authority) demands that patients are informed of the OFSEP project and sign an informed consent form before the collection and transmission of their data for OFSEP project research. Depending on whether the patient is in the active patient population or not (no consultation for more than five years), he can be informed during a consultation or hospital stay and sign the consent form, or be informed by post.

Documents (in French)

• OFSEP consent form adult patients [v3.0 - Application date : 16/02/2022]
• OFSEP consent form parents/minor patients [v3.0 - Application date : 16/02/2022]
• Information sheet - 13 years old and over patients [v3.0 - Application date : 16/02/2022]
• Information sheet - under 13 years old patients [v3.0 - Application date : 16/02/2022]
• Consent management rules [v4.0 - Application date : 09/07/2024]

Tools (in French)

• Identification of patients to whom a consent form is sent by post: Identification des patients pour envoi de consentements OFSEP v10 (EDMUS 570-571).xls [updated 10/03/2022]
• Task list summarizing the documents to be sent to patients who have not consulted in the past five years [Diffusion date : 15/07/2020]
• Letter model to be used on the headed paper of your department and modified as you see fit, to explain the purpose of the letter to patients who have not consulted recently.
• Consent catch-up instructions [Diffusion date : 19/03/2021]

Collection of minimal data by the neurologist

The clinical group has defined a set of minimal clinical data that all the neurologists participating in the OFSEP project undertake to collect during each patient consultation or hospitalization. These data are mandatory for all patients who have consulted at least once since 15 June 2013. 
To ensure the collection of homogeneous and quality data, it is highly recommended that these data are collected using the paper form entitled "OFSEP minimal form". To adapt to local practice, this OFSEP minimal form exists in two formats: a log book to enable patient follow-up over several years and a two-sided form to be used for each consultation or hospitalization.

Guides (in French)

• Guide for use and input of the OFSEP minimal form [v5.0 - Application date 19/12/2022]
• Guide for use and input of the Covid-19 questionnaire [updated 26/04/2021]
• Guide for use of the personal data questionnaire [v1.0 - 22/11/2021]
• Guide for use of the geographical origin patient auto-questionnaire (EDMUS centre) [v1.0 - 22/11/2021]
• Identification of progression and irreversible disability
• First Steps with OFSEP [v2.0 - 08/10/2021]

Documents (in French)

• OFSEP minimal form [Application date 26/09/2022]
• OFSEP minimal form - serious adverse event [Application date 26/09/2022]
• COVID-19 questionnaire [updated 26/04/2021]
• Covid-19 vaccination certificates [updated 26/04/2021]
• Personal Data questionnaire [v1.0 - 22/11/2021]
• Geographical origin patient auto-questionnaire (EDMUS centre) [v1.0 - 22/11/2021]

Data input and quality check in EDMUS

After collecting the data, they must be entered in EDMUS. Coherency must be verified directly in EDMUS using the “data checkup” tool.

Guides (in French)

• Guide for use and input of the OFSEP minimal form [v4.0 - Application date 26/09/2022]
• EDMUS user guide
• User guide for the data checkup module in EDMUS

Data export to the National Coordination Center

The data collected in the local EDMUS databases of OFSEP participant centers must be exported on 15 June and 15 December to enable compilation of the common clinical database. For specific studies, additional exports may be requested. The data must be encrypted using the GnuPG software before transmission to the National Coordination Center.

Guides (in French)

• EDMUS data export for transmission to OFSEP - Cohort data [v5.0 - Application date 05/11/2024]
• GnuPG v2b installation and user guide

Pre-requisites for a center to participate in the OFSEP project: declaration of the EDMUS database to the CNIL

The pre-requisites for a center to participate in the OFSEP project are signature of an agreement by both the center and OFSEP, and declaration of the center's EDMUS database to the CNIL.

• CNIL registration procedure for the EDMUS database (in French)

Read the FAQ or contact us if you have any further questions.