General Information
What is the difference between the Neurostatus-EDSS and Kurtzke-EDSS?
The Neurostatus-EDSS is a disability status scale that summarizes the assessment of seven Functional Systems (FS) and the ambulation score (AS) in patients affected by multiple sclerosis (MS) or other demyelinating diseases. Each FS consists of a set of subscores representing the neurological physical examination and patient’s reported symptoms. The final EDSS step is calculated based on the FS scores (FSS) and AS in a previously standardized method (EDSS scoring table).
The Neurostatus-EDSS was developed, standardized, and adapted from the version of J. Kurtzke’s 1983 scale, with the aim not to modify but to further improve inter- and intra-rater reliability and consistency in assessments by providing less ambiguous definitions of the grades than those provided by the original scale. Until recently, the Neurostatus-EDSS has been adopted in more than 200 phase II and III RCTs in MS, that include most pivotal trials that led to approval of current DMT.
Role and tasks of Study Administrators
The Global Study Administrator:
– Main contact person for Neurostatus Systems regarding e-Test application/administration/support.
– Managing and monitoring the Sponsor/CRO Study administration team in a dedicated study administration section on Neurostatus.net.
– Add, remove, replace (backup) Global Study Administrators and/or Regional/Country Study Administrators.
– Assign access rights to other Study Administrators (read/write/delete).
– Send Login information to Study Administrators.
If regional or country Study Administrators are assigned:
– Handover of responsibilities to regional/country Study Administrators.
– Train the regional/country Study Administrators according to their access rights.
Tasks of a Study Administrator:
– Track EDSS Raters, their status and certificates (automated email notification, list for download available).
– Confirm EDSS Raters requests for certification (or re-certification).
– Add EDSS Raters already registered on Neurostatus.net to the study (Add Investigator).
– Resend expiration emails to EDSS Rater if re-testing has not been performed despite automated notifications (expired Qualification).
Overview on administration tools
Investigator list
The list shows all Investigators registered for certification in your study, as well as important information for each investigator. The registration counter (Results 0-50 of XXX) shows the total number of registered Investigators independent of their test status.
NOTE: You can sort the list by Name, Country, Site Nr, Status, Test date, Entry.
Info / Contacts
Provides study contact information and edit options for Global Administrators.
• Study Information provides overview on general study information
• Administrators offers diverse edit options to Global Administrator
• Contacts shows Sponsor’s contact information
• Activities tracks all changes performed in this section
Download Center
Download Investigator list, scoring documents, qualification documents and instructions for Investigators.
Mailing
A mailing tool for Administrators to contact participating Investigators and/or the administration team.
Status (pulldown) / Search
These functions enable you to sort all investigators by test status or to search by name, email, country or centre/site number.
Add Investigator
The study administration can request automatic re-certification for investigators, who previously obtained EDSS certification via Neurostatus e-Test or via a Neurostatus paper test at an investigator meeting.
Print Preview
When printing the overview sheet, please change your print setup to landscape in order to optimize printing. Some printers offer the option to save print previews as a PDF-file.
NOTE: Before printing the overview sheet you are allowed to sort the list by Status (pulldown), and/or by Name, Country, Site Nr, Status, Test date, Entry.
Info/Actions
Various icons provide you with important functions/tools to easily administrate the investigators registered in your study.
How long does it take for a material order to be shipped?
Once the material order is confirmed by the Neurostatus team, it takes approximately two weeks for production and one additional week for the shipment, depending on the destination country. All materials are produced in and shipped from Switzerland.
What are the roles of the investigators allowed, who determines them and what impact do they have on the study?
During the e-Test study setup, the setup Admin must select any, some, or all of the following options:
- Treating Physician
- Evaluating Physician
- Study Coordinator / Nurse
- Study Personnel
- Other
- Create your own role
It is entirely up to the Sponsor which roles they want to choose for their raters performing assessments under their study. The grouping has no impact on the study data nor the certification process, and is simply a way for the Sponsor to categorize and gather information about their investigators.
Edit tools
Add/edit Administrators, send access information
During the course of a project the administration personnel may change, or contact details of an Administrator needs to be updated.
Global Administrators are offered to:
• Edit personal contact details by selecting link ‘My Account’
• Maintain Administrator accounts by selecting link ‘Administrators’ offering the following options:
– Add Administrators
– Remove or replace Administrators
– Determine administration settings and access rights
– Send activation/invitation emails
Regional/Country Administrators are offered to:
• Edit personal contact details by selecting link ‘My Account’
NOTE: Administrators are responsible for their personal data!
Change investigator data

NOTE: Investigators are responsible for their personal data and have the necessary tools to perform any modifications!
Add Investigators
Automatic re-certification of an investigator – Add investigator
The study administrator can process automatic re-certification for an investigator obtaining a valid Neurostatus e-Test Qualification on Neurostatus database.
- Select menu Add investigator.
- You are asked to enter the investigator’s email address or his/her first and last name, to check if the investigator has previously obtained EDSS qualification on Neurostatus.net.
- Follow procedure and submit.
- An email is automatically sent to the investigator, informing him/her of the successfull re-certification.
- The new data will automatically appear in menu Investigators as “confirmed (re-A)”
Please note that re-certification can be refused:
- If the last e-Test of an investigator has been taken prior to allowed time window for re-certification set in parameters of your study (e.g. 12 or 24 months)! Study parameters can be viewed in ‘Info/Contacts’, ‘Study information’.
- If the e-Test of an investigator does not represent the qualification level requested by your study or a higher level (Qualification levels A,B,C)!
View, confirm, reject, deactivate or delete Investigators
View details of investigator’s e-Test

The e-Test archive provides you with detailed information about the e-Test trials and achieved scores for this specific investigator.
Confirm or reject request for qualification
A request for qualification is sent to the study administration if an investigator has successfully passed the Neurostatus e-Test and requests participation or automatic re-certification for this particular study.
Confirmation of a request:

- An email informs you of an investigator’s request for qualification in your study. This investigator has a valid Neurostatus qualification for your study (with requested test level A, B or C).
- If this investigator is a registered participant in your study, you must confirm his/her request in order to validate it.
- After confirming the request, this qualification will be valid for your study. An email confirmation will be sent to the investigator.
Rejection of a request:

- An email informs you of an investigator’s request for qualification in your study. This investigator has a valid Neurostatus qualification for your study (with requested test level A, B or C).
- If this investigator is not a registered participant in your study, you can reject his/her request.
- After rejecting the request, this investigator’s data will be removed from your administration sector. An email notification will be sent to the investigator.
Deactivate investigators in your list
on-icon to deactivate
or
to reactivate an investigator’s data in your study administration sector.
The investigator will receive a notification in his/her personal e-Test account.
Investigators whose status is deactivated will no longer receive email notifications for reminded/expired e-Tests.
Delete investigators from your list

Click on icon to delete an investigator’s data from your study administration sector. The investigator will receive a notification in his/her personal e-Test account.
NOTE: Once an investigator’s data has been deleted, earlier Qualifications for this study will not be trackable anymore.
Expiration of an Investigator’s Qualification
Expiration of a Neurostatus e-Test Qualification
The period of validity of a Neurostatus e-Test Qualification is defined by the Steering Committee of the respective study.
Process:
- Investigator receives first email notification (reminder) one month before his/her certification is expiring.
- A second notification is sent on day of expiry.
- Additional reminders have to be triggered by the Study Administrator.
Resend expiration notification to an investigator

Click on icon to resend an expiry notification to an investigator. An email window will pop-up, stating that this particular Investigator needs to retake the test. Administrators are allowed to modify the email.
Download Options
Print / download qualification document

Qualification status
Download Investigator list, Scoring documents, Qualification documents and Instructions for Investigators.
NOTE: Before downloading the excel file you are allowed to sort the list by Status (pulldown), and/or by Name, Country, Site Nr, Status, Test date, Entry.
Expiration of qualification
The qualifications for several studies on Neurostatus.net expire after a limited period of validity (e.g. 12 or 24 months). If a qualification expires for a study for which you are qualified, you will be informed in advance. You will then have to repeat the Neurostatus e-Test to renew your qualification. The renewed qualification will be valid for all the other studies on Neurostatus.net in which you are participating, if the level of qualification corresponds to the level needed in the respective study.
After going live
Can we make changes to the License Agreement or eTest setup after the study is Live?
Yes, we can arrange a contract amendment to the License Agreement (LA) at any time. Please contact the Neurostatus Operations team directly via neurostatus-uhbs@usb.ch if you wish to make any kind of amendment to the eTest setup or LA, including but not limited to:
- change of recertification term,
- increase/decrease investigator tier,
- add countries,
- study duration extension,
- study cancellation
- early termination,
- change of protocol name,
- etc.