This page shows the descriptions relevant to the various actions. If you do not find the answer to your question, please contact OFSEP.

General questions

• Is OFSEP a public or private-sector structure?
• I would like to learn to use EDMUS, how do I go about it?
• How to access OFSEP data?
• Does the CNIL authorization granted to OFSEP cover all the uses that may be made of the data?
• What are the rules applicable to publication of an article or submission of an abstract concerning OFSEP data or using OFSEP resources?
• How can I attend the OFSEP convention?

Clinical

• How to become an OFSEP clinical investigation center?

Imaging (MRI)

• How to get OFSEP certification for my imaging center?

Biology — clinic / hospital department

• How can I get sample kits?
• Who fills in the EDMUS identifier on the sample form, and when?
• What is the maximum period between the first and last samples using the same kit?
• Is there a procedure for taking a blood sample from a patient?Does the patient have to have fasted?
• Is there a procedure for taking a urine sample?

Biology — Biological Resource Center (BRC)

• What must be checked on the consent form?
• What is the maximum time within which a sample must be taken?
• What types of non-conformance apply to sample reception and what action must be taken?
• Can the peripheral blood mononuclear cells (PBMC) be frozen?

 

General questions

 

• Is OFSEP a public or private-sector structure?

OFSEP is a consortium involving Claude Bernard Lyon 1 university (UCBL), the Lyon University Hospital and the Eugène Devic EDMUS foundation for multiple sclerosis, an organization of public interest. OFSEP is funded by the ANR, France's national research agency.

 

• I would like to learn to use EDMUS, how do I go about it?

OFSEP's National Coordination Center proposes to participating centers a telephone training course for the EDMUS software. The session lasts approximately two hours and is open to CRAs and doctors. It covers the software functions and the particularities related to the entry of OFSEP minimal data. To arrange a session, please contact: This email address is being protected from spambots. You need JavaScript enabled to view it..

Generic documentation on use of the software and specific to the entry of OFSEP minimal data is also available here (in French).

 

• How to access OFSEP data?

The OFSEP cohort is open to researchers, whether internal or external to the project, associated with public or private bodies, from France or abroad.

A research project must be submitted to request access to OFSEP data. The project will be evaluated by OFSEP's National Coordination Center, Scientific Board and Steering Committee.

Find out more about data access

 

• Does the CNIL authorization granted to OFSEP cover all the uses that may be made of the data?

No, OFSEP has been authorized by the CNIL to compile a database of clinical data, biological samples and MRI examinations for parents in the OFSEP cohort.

This CNIL authorization does not relieve individual project leaders of their obligation to submit their projects to the competent authorities (for example CCTIRS, CNIL, CPP, in France, etc.). Project leaders can contact the This email address is being protected from spambots. You need JavaScript enabled to view it. at the National Coordination Center to find out more about OFSEP and the details necessary to draw up their file.

 

• What are the rules applicable to publication of an article or submission of an abstract concerning OFSEP data or using OFSEP resources?

OFSEP has published a publication charter governing the terms and conditions of publication in the event of use of OFSEP data or resources. If a contract is signed by OFSEP and a project leader, different provisions may be indicated therein, which then prevail over the terms of the charter.

 

• How can I attend the OFSEP convention?

The convention is by invitation only.

For further information, contact OFSEP.

 

Clinical

 

• How to become an OFSEP clinical investigation center?

OFSEP clinical investigation centers are French public or private sector hospital centers with an active department monitoring MS patients. These centers undertake to collect the minimal OFSEP data (see Participating Centers).

At present, no more OFSEP centers are being opened. For more information, This email address is being protected from spambots. You need JavaScript enabled to view it..

 

Imaging (MRI)

 

• How to get OFSEP certification for my imaging center?

Any French imaging center can be OFSEP certified. To register, please follow the instructions in the “Integration procedure for the OFSEP project Imaging WP” document (in French).

 

Biology — clinic / hospital department

 

• How can I get sample kits?

If you are a participating centre working with an OFSEP BRC, you can ask for OFSEP sample kits. Simply send a request to: This email address is being protected from spambots. You need JavaScript enabled to view it.

It may take up to two weeks for your kits to be delivered.

 

• Who fills in the EDMUS identifier on the sample form, and when?

The doctor or an identified party (depending on the center's specific organization) fills in the EDMUS identifier on the form when the sample is taken.

 

• What is the maximum period between the first and last samples using the same kit?

24 hours.

 

• Is there a procedure for taking a blood sample from a patient? Does the patient have to have fasted?

No, there is no specific procedure.

 

• Is there a procedure for taking a urine sample?

Urine should be taken “mid-stream”.

 

Biology — Biological Resource Center (BRC)

 

• What must be checked on the consent form?

• Nominative data and date of birth for the patient
• The decision to accept or refuse the collection and conservation of biological samples in a BRC for research use in the OFSEP project
• The decision to accept or refuse that samples are used for genetic analysis as part of the OFSEP project
• The decision to accept or refuse that clinical, imaging or biological data are used in research programs
• Patient and doctor's signatures on the second page

 

• What is the maximum time within which a sample must be taken?

Samples can be taken up to 24 hours after the patient sample is taken.

 

• What types of non-conformance apply to sample reception and what action must be taken?

The types of non-conformance and actions to be implemented are listed in the table below:

Non-conformance	Action	Treatment possible?
Incorrect sample transport temperature	Inform the sampling department	Yes
Samples not identified	Return to the sampling department	No
Sample arrival after deadline	Inform the sampling department	Yes if freezing time < 24 hours
Expired, missing or broken sample tubes	Inform the sampling department to order new kits	Yes if possible
Insufficient sample volume	None	Yes
Sample form missing or incorrectly completed	Ask the sampling department for the form or request its completion	Yes
Consent form missing, unsigned or incorrectly completed	Ask the sampling department for the completed, signed consent form	Yes Destruction if consent is not obtained

 

• Can the peripheral blood mononuclear cells (PBMC) be frozen?

Yes, PBMCs can be frozen using 4% human albumin instead of human serum AB (SAB), provided this information is specified on the sample form.