Haemovigilance reporting unavailable from Wednesday 19 to Thursday 27 March 2025 Click here for more information

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Haemovigilance reporting unavailable from Wednesday 19 to Thursday 27 March 2025

MHRA are moving to a new software platform for SABRE, so SABRE/SHOT reporting will be unavailable from Wednesday 19 to Thursday 27 March 2025.

Update from MHRA on Tuesday 25 March:

Dear Colleague,

Good progress is being made to prepare the new SHOT/SABRE reporting platform.  We have successfully created your organisations and migrated SABRE records into our surveillance database.  All that remains is to transfer those migrated reports into your new Workspaces. This will be performed in the early hours tomorrow and will be validated tomorrow.  If all goes well we should be ready to start the onboarding process Tomorrow afternoon or Thursday morning.  We will then notify you and send out the link.

Apologies for the slight delay and thank you for your patience.

Key Dates:

  1. 18 March – suspend all SABRE account on Notes
  2. 19/20/21 March – deliver online training on new software platform
  3. Migration of old data to new platform
  4. MHRA verify migration success, 22/23 March
  5. 24/25th March receive email to verify successful launch and start the on-boarding process
  6. 24/25th March reporters start to use the new platform

During the process you will not be able to use the old SABRE platform and unable to report to SHOT.  Please bear with us during this set up phase.  This will not affect your regulatory status to report “as soon as known” during this downtime.

For any queries regarding the new MHRA reporting system & requests for calendar invites for online training sessions , please contact the MHRA Haemovigilance Team [email protected]

Dear colleague,

We are shortly about to move the SABRE/ SHOT reporting platform from Lotus/ HCL Notes software to a new bespoke platform. 

You will be required to nominate at least one representative from each of your organisations to take the role of “Organisation Lead” for your reporting organisation in preparation.  The quick start guide is attached and Team meeting webinars will be set up to demonstrate the system.  Don’t worry if you can’t attend a session as the guide and future instructions will allow you access to the new platform.

The online demonstration will give an overview of the changes made, the different “roles”, the set up of accounts and how to report.  The new platform;

  • Will not require a single set of log in details that is shared among your colleagues
  • Will allow individuals to set up a reporting account which then links to your organisation
  • Has two roles, a reporter, with general access rights to a dashboard where you can view reports in your workspace and submit new reports and an “organisation lead” role where the person will be able to invite individuals and manage who has access to reports, make changes to your organisation details, and also make reports.
  • Allows reporting of SAEs and SARs, Notifications and Confirmation reports, add attachments and Footnotes and links to SHOT database as now.
  • Has updated features such as an improved workspace and export of the workspace into a spreadsheet for in depth trending and monitoring.

The “organisation lead “ role is not intended to be undertaken by any specific person with a particular job title, so does not have to be the Consultant, Lab Manager, Transfusion Practitioner, etc, nor have any particular seniority, but is someone who will act as the main contact and take the responsibility for managing the organisation account and reporters.  This role will be made clearer in the demonstration.  For the purposes of the demonstration, we would require that person to attend at least, and if you want, some of the other interested reporters, but not necessarily every single reporter you intend to report to MHRA and SHOT.

Instructions for creating your personal accounts and the new log in will be provided nearer the time.

Key Dates

  1. 18th March, afternoon, suspend all SABRE account on Notes
  2. 19/20/21st March schedule Team’s demonstrations (TBA)
  3. Migration of old data to new platform
  4. MHRA verify migration success, 22/23 March
  5. 24/25th March receive email to verify successful launch and start the on-boarding process
  6. 24/25th March reporters start to use the new platform

During the process you will not be able to use the old SABRE platform and unable to report to SHOT.  Please bear with us during this set up phase.  This will not affect your regulatory status to report “as soon as known” during this downtime.

Many thanks

[email protected]

Pilot user guide v2 (880kB docx)