Escalation process
- If an assessment still has inconsistencies after three EDSS Expert Review rounds, the assessment is labelled as ‘Escalated’.
- Escalated assessments are stored in a separate list.
- The EDSS Expert from Neurostatus-UHB informs the Sponsor by email (expert.edss@usb.ch) about the escalated assessments and explains the reason for the escalation.
Disagreement
- If the reason for the assessment’s escalation is a disagreement, the Sponsor shall set up an online meeting using Microsoft Teams, Zoom, Google Meet, or any other platform that can accept external guests and has the option to share the screen. It is mandatory for the Sponsor as well as the EDSS Rater to participate in the meeting. As an alternative, resolving the disagreement by exchange of emails between the EDSS Rater and the EDSS Expert is also possible, provided that the Sponsor is in copy of all such communications.
- After the meeting/exchange of emails has taken place:
- If there is an agreement, the EDSS Expert sends the assessment back to the site to be updated by the EDSS Rater and make the necessary amendments.
or
- If there is NO agreement, the assessment is flagged and the Sponsor takes the final decision about the assessment data.
NOT a disagreement
- If the reason for the assessment’s escalation is NOT a disagreement (e.g. a technical problem, a communication issue or a misunderstanding of the recommendations), the Sponsor should contact the site and/or the EDSS Rater to explain the issue. There is NO communication between the EDSS Rater and the EDSS Expert.
Once the EDSS rater is aware of the issues that need to be addressed:
- The Sponsor informs the EDSS Expert and asks to send the assessment back to the site in order for the EDSS Rater to make the necessary adjustments.
or
- The Sponsor informs the EDSS Expert and requests an online meeting if the EDSS Rater does not agree with the EDSS Expert’s recommendations.
Escalation process for Sanofi EFC16033, Sanofi EFC16034, Sanofi EFC16035, and Sanofi EFC16645
- If an assessment still has inconsistencies after three EDSS Expert Review rounds, the assessment is labelled as ‘Escalated’.
- Escalated assessments are stored in a separate list.
- The Sponsor/local CRA informs the EDSS Expert from UHB by email to this email address: expert.edss@usb.ch
- The Neurostatus EDSS Expert from UHB sends the reason for the escalation to the Sponsor/local CRA by email.
Disagreement
- If the reason for the assessment’s escalation is a disagreement, the Sponsor/local CRA sets up an online meeting using Microsoft Teams, Zoom, Google Meet, or any other platform that can accept external guests and has the option to share the screen. It is mandatory for the Sponsor/CRA to participate in the meeting as well as the EDSS Rater. As an alternative, resolving the disagreement by exchange of emails between the EDSS Rater and the EDSS Expert is also possible, provided that the Sponsor is in copy of all such communications.
After the meeting/exchange of emails has taken place:
- If there is an agreement, the EDSS Expert sends the assessment back to the site to be updated by the EDSS Rater and make the necessary amendments.
or
- If there is NO agreement, the assessment is flagged and the Sponsor takes the final decision about the assessment data.
NOT a disagreement
- If the reason for the assessment’s escalation is NOT a disagreement (e.g. a technical problem, a communication issue or a misunderstanding of the recommendations), the sponsor/CRA should contact the site and/or the EDSS Rater to explain the issue. There is NO communication between the EDSS Rater and the EDSS Expert.
Once the EDSS rater is aware of the issues that need to be addressed:
- The Sponsor/CRA informs the EDSS Expert and asks to send the assessment back to the site in order for the EDSS Rater to make the necessary adjustments.
or
- The Sponsor informs the EDSS Expert and requests an online meeting if the EDSS Rater does not agree with the EDSS Expert’s recommendations.