Study Administrator FAQs

We can provide an interactive web-based Neurostatus-EDSS training (up to 50 investigators per session). This training provides a general introduction with focus on common areas of difficulties and offers real time interaction with the EDSS expert. Prices and Conditions to be provided upon request.

In rare cases, raters do not pass the exam after four attempts. They are asked to contact their Study Administration for further advice. Study Administration may send a request for additional training to the Neurostatus Operations team.

A personal EDSS Training is offered online, provided by an EDSS expert of Neurostatus-UHB. Duration of training is 45 minutes. The training offers (in short form) the presentation held at investigator meetings, with focus on questions from the rater. After the training the rater receives a new exam opportunity in NeuroCert which can immediately be taken.

The overall goal of this training is to provide further understanding of the Neurostatus EDSS Scoring Booklet version 04/10.3.

This training is designed to include exercises covering common mistakes and to address specific questions from Raters.

The TC training is designed to last 45-60 minutes in a one-on-one fashion, but can vary depending on specific circumstances such as internet connection, number of Raters, need for translation, etc.

We provide the EDSS scoring table Version 04/10.3 and the visual FSS calculation table if the rater does not already have them. We do not provide copies of the presented slides before or after the training.

Unfortunately, we cannot provide any feedback on your NeuroCert exam answers. Immediately upon submitting an attempt, you will receive a list of the topics that you should review as a list of training recommendations.

No answers to exam questions can be provided before or after the TC training.

No. The need for a translator should be arranged for and covered by the Sponsor and/or site.

The TC training is currently offered in English and Spanish.

It can take between one to two business days before the test is availble.

A new set of four attempts is granted after the TC training has been completed.

Yes, if the Rater is linked to a clinical trial and/or needs to be certified.

Whilst the training is designed in a one-on-one fashion, a maximum of three Raters could be allowed in this training.

Sponsor or Rater should provide a link meeting for Microsoft teams, zoom, or similar. It is not mandatory for Sponsors to be in the training unless they consider it necessary.

Microsoft Teams, Zoom, Google Meet, or any other platform that can accept external guests and the option to share the screen.

We highly recommend a bandwidth of at least 10mbps for a high quality one-to-one virtual meeting.

Please ask a Head Administrator, who has the rights for all regions.

There are several possibilies. Please read the error message carefully.

• The user has already been invited to this study. Please check the study assignment and also the account status. This should inform you, where the rater got stuck
  • the rater has not yet registered. If you feel you,ve waited long enough, contact them.
  • the rater has declined the invitation. If you believe by mistake, contact them.
• The user account is inactive

No. Please cancel the current invitation and create a new one.

Due to segregation of duties, the creation of one user with both an administrator and a rater account is not possible.

No, you cannot remove the region “default”, however you can rename it. All raters will be assigned to this region.

Study Head Administrator manages the Study settings and Study access from the Sponsor/CRO side.

Study Rater Administrator has limited permissions. They can manage Raters but not study settings or other Study Administrators.

Viewer have read-only access.

• Add and deactivate Raters
• Track Raters, their status and certificates (automated email notification, list for download is available upon request).
• Resend reminder emails to Raters if re-testing has not been performed despite automated notifications (expired Certification).

In addition, Study Head Administrators:

• Main contact person for Neurostatus-UHB regarding NeuroCert application/administration/support.
• Managing and monitoring the Sponsor/CRO Study Administration team on NeuroCert.
• Add, remove, replace Study Head Administrators and Study Rater Administrators.
• Ensure Study Administrators are trained.

Yes, as long as there is no conflict of interest.

For Raters, an existing certificate might cause them to directly receive a valid certificate for the other study.

Raters with a valid, existing exam on NeuroCert from another study may use their exam to directly certify for a new study, granted that the parameters of the term and level passed match those established by the new study.

The Neurostatus NeuroCert contains three different Levels of Certification. Based on the phase (1, 2 or 3) of the clinical trial, these levels reflect the expected knowledge of an investigator in performing a standardized examination and EDSS rating.

The Steering Committee of each study will decide which level is needed for a successful Neurostatus Certification. Once selected, a qualification level should not be changed for the duration of the study, hence it is critical the correct level is selected during the study setup.

Level A = passing 30 of a possible 50 points:
Allows re-certification for studies requiring Level A Certification.

Level B = passing 34 of a possible 50 points:
Allows re-certification for studies requiring Level A or B Certification.

Level C = passing 38 of a possible 50 points:
Allows re-certification for studies requiring Level A, B or C Certification.

The Certification for several studies on NeuroCert expire after a limited period of validity (e.g. 12 or 24 months). If a certificate will expire for a study for which you are qualified, you will be informed one month in advance. You will then have to retake the exam to renew your Certification. A renewed Certification will also be valid for all the other studies on NeuroCert in which you are participating, if the level of Certification corresponds to the level needed in the respective study.

Yes, we can arrange a contract amendment to the License Agreement (LA) at any time. Please contact the Neurostatus Operations team directly via operations@neurostatus-uhb.com if you wish to make any kind of amendment to the NeuroCert setup or LA, including but not limited to:

• change of recertification term,
• increase/decrease investigator tier,
• study duration extension,
• study cancellation / early termination,
• change of protocol name,

Regions can be edited by all Study Head Administrators before and after go-live.

A rater may be blocked because they have failed 3 consecutive times. The rater needs to unblock the 4th attempt by directly answering the questionnaire which appears directly on their screen.

For further assistance, see the rater manual.

In rare cases, raters do not pass the exam after four attempts. They are asked to contact their Study Administration for further advice. Study Administration may send a request for additional training to the Neurostatus Operations team.

A personal EDSS Training is offered online, provided by an EDSS expert of Neurostatus-UHB. Duration of training is 45 minutes. The training offers (in short form) the presentation held at investigator meetings, with focus on questions from the rater. After the training the rater receives a new exam opportunity in NeuroCert which can immediately be taken.

In the Studies section of your personal account, you have access to your raters Neurostatus-EDSS Certificates at any time.

• Valid: Your Neurostatus EDSS Certification is valid for this study.
• Pending: There is no valid Neurostatus EDSS Certification for this study.
• Expiration upcoming: Your Neurostatus EDSS Certification for this study will expire within the next month. You should retake the NeuroCert within the next month.
• Expired: Your Neurostatus EDSS Certification has expired for this study. If you are still particiapting, in the study, you must retake the NeuroCert as soon as possible. If you don't please have the Study Administrator deactivate your assignment

No, only NeuroCert exams taken on our platform are recoginized as valid.

Once the material order is confirmed by the Neurostatus Operations 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.

All personal data, study assignments, exams, and activity logs have been migrated

The study configuration, study assignments for raters and administrators, and activity logs have been migrated

These are raters whose study participation has not been confirmed by a study administrator. If you want them to join the study, re-invite them by clicking on “canceled” and then “re-invite”. If you don’t, no action is needed

If the study administrator had not finished the registration before migration, there was no account to migrate. Please invite them following the standard process.

In a similar situation, raters have been migrated unless the invite was more than a year old.