Dear Colleague

Changes to SABRE and haemovigilance reporting in the UK

You are receiving this email because you are either the registered account holder for your local MHRA SABRE account, or you are on a distribution list within your hospital to receive emails forwarded from your local HTT email in-box. If haemovigilance emails are no longer relevant to your role, please ensure you are removed from your local distribution list.

I am contacting you to let you know that SABRE is changing. Since 2005, MHRA have run SABRE, an online reporting tool to allow reporters to log SAEs and SARs as required by the Blood Safety and Quality Regulations (2005) (as amended) to the Competent Authority. SABRE has additionally provided a way of linking SABRE reporting to reporting to SHOT on their reporting database. The software which enables SABRE is soon to be upgraded to a different software package.


The new software will look and function differently to the existing version but will allow you to meet your requirements as reporters under the regulations. You will still have access to your old reports, you will still have access to the SHOT database via a link from your Workspace and where possible we have removed some functionality and replaced it with new or enhanced functionality. Further details of the changes made, and an updated user guide are attached

We are currently undergoing final testing of the new system which will occur in three phases:

  1. We will migrate data from old SABRE to new. To do this, SABRE will need to be de-activated during which time you will not be able to log on to SABRE and you will not have access to the SHOT database.
  2. We will verify that the migration has been successful, and the system is working properly with the new data.
  3. Assuming the data migration has been successful, we will send you your new log in details.


If the migration were not to be successful, we would reinstate the old SABRE system and contact you with our revised plan for migration.

During the migration period when SABRE is de-activated, reporters will not be expected to report SAEs and SARs “as soon as known” to meet the regulatory requirements. However, please do not hesitate to contact us by phone if you need any information or want to advise us of serious regulatory matters affecting your ability to function safely.

SABRE will therefore be de-activated from 3pm on Friday 15 June, with migration due to be completed by Sunday 17 June. We will have verified this migration by Wednesday 20 June and would therefore plan to send you your new log in details on or sooner if the process is completed quicker. You will be notified of any significant changes to this plan.

You are encouraged to log into the new SABRE when you receive your new log in details so you can change the temporary password before it expires, even if you don’t have anything to report.

If you have any queries or concerns, please don’t hesitate to contact me on 020 3080 7336 or reply to this email.

Regards

Chris

SABRE Quick start guide.pdf

Joint UK Haemovigilance user_guide 2018.pdf