SAE audit

Following recent monitoring visits, it has been noted that a number of serious adverse events (SAEs) have not been reported to the Trial Office as stated in the SPIRIT 2 protocol. The MHRA has deemed this to be a serious breach and requested that a review be conducted to identify any additional unreported SAEs.

In order to address the necessary corrective actions, we will be contacting all sites this month (July 2017) via email and requesting confirmation that a full review of all medical notes (paper and electronic) for patients participating in SPIRIT 2 has been performed at site.

Any unreported SAEs identified during the review, must be reported using the SPIRIT 2 SAE form, which can be found in the SPIRIT 2 Investigator Site File and the SPIRIT 2 Website ( Please fax the completed form to 0191 376 0748 within 24 hours of becoming aware of the SAE.

If you have any questions, please do not hesitate to contact your Trial Manager or the SPIRIT 2 Trial Office. 

Last modified: Thu, 13 Jul 2017 15:07:15 BST