Informed Consent v2.0
Dear SPIRIT 2 Sites
It has been brought to our attention that the recently amended SPIRIT 2 Informed Consent Form v2.0 has a typographical error. Point 1 of the Participant Consent Form lists the date of the patient information sheet (02 March 2016). This date is different to the actual date of the patient information sheet (08 June 2016). Please see document section.
The error has been corrected so both dates now match (02 November 2016) and the document has been up versioned to v2.1. REC has been advised of this and as it is a minor change, approval is not required, and the change can be implemented immediately.
The amendment applied to any patient who was still taking study medication which is all patients on imatinib or dasatinib who have not reached visit 15 and all patients on post 5 year supply of dasatinib. We realise that many sites have already implemented the amendment so please see below for action needed:
1. Any patients who have still to re-consent to the study, need to be re-consented to v2.1 of the consent form
2. Any patients who have already re-consented to version 2.0, do not need to reconsent to version 2.1, however the signed consent form needs to be amended in the following way:
- 02 March 2016 scored through,
- Date replaced with 08 June 2016
- The change is initialled & dated
Once a patient has re-consented please fax or email a copy of the signed Informed Consent Form to 0191 376 0748 or firstname.lastname@example.org
If you have any questions please do not hesitate to get in touch.
Last modified: Thu, 02 Feb 2017 15:05:59 GMT