Substantial Amendment 50

Please see below the email sent to sites Friday 10th February 2017.
Documents have been filed in the relevant section in the ISF tab of the website (Study specific documents part 1, Central approvals –REC and Central approvals – MHRA).
Dear Colleagues,
Please find attached documentation relating to Substantial Amendment 50 (REC numbering) for the SPIRIT 2 Trial. This amendment introduces an updated protocol (version 2.1); allows the use of generic imatinib for SPIRIT 2 patients; and also introduces two new documents relating to data privacy.
Please read the attached amendment guidance which includes a list of the amendment documentation and further information relating to the implementation of this amendment at your site
Next Steps:

  1. Please ensure that the amendment documents are forwarded to your local R&D office for review
  2. Once local authorisation is obtained please ensure that confirmation of this is forwarded to the SPIRIT Office,
  3. Please complete and return the Generic Imatinib Information Slip
  4. Once you have received local R&D approval to implement the amendment,  please contact the SPIRIT Office to request a Privacy Notice Poste
  5. Please ensure that all the amendment documentation is filed in your Investigator Site File

In line with the HRA categorisation email and UK wide policy on the handling of amendments, your site is given 35 days from the date of this notification to raise an objection about the amendment. If we do not hear from your R&D office by Friday 17 March 2017 it will be assumed that the amendment may 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
If you notify us ahead of this date that you are able to implement this amendment it will enable us to potentially implement it sooner.
Please note that, in line with the HRA categorisation email, we will not implement this amendment at a site which requests more time to consider the amendment until we receive confirmation from the site that the amendment can be implemented.  

Last modified: Mon, 13 Feb 2017 09:42:02 GMT