The SPIRIT office contacted sites recently regarding Substantial Amendment 50 (REC numbering) for the SPIRIT 2 Trial.
The amendment introduced an updated protocol (version 2.1); allowed the use of generic imatinib for SPIRIT 2 patients; and introduced new data provacy documents.
The 35-day period in which to raise an objection ended Friday 17 March, therefore in line with the HRA categorisation email and the UK wide policy on the handling amendments if we have not heard from your R&D office we will now assume that the amendment can be implemented at your site.
If more time is needed for consideration of the amendment please contact the SPIRIT Office on 0191 282 0904 or email email@example.com immediately.
If you have already been in contact with us about stopping the clock for this amendment, there is no need to act on this informaion.
Last modified: Tue, 28 Mar 2017 14:11:00 BST