Documents and Downloads
Please download any of the files below by clicking "Download".
Study Conduct (8)
SPIRIT 2 Protocol - v1.4
- last updated 20 March 2008
SPIRIT 2 protocol
PIL/IC Form - v1.2
- last updated 12 March 2008
SPIRIT 2 Patient Information Leaflet and Informed Consent Forms
GP Letter - v1.0
- last updated 07 November 2007
Site Delegation Log - v1.0
- last updated 26 November 2008
Site Personnel Delegation Log - Documents site staff approved by the PI to be involved in study procedures.
Screening Log
- last updated 04 September 2009
Site Patient Log
- last updated 27 November 2008
SAE Form - v2
- last updated 01 August 2009
Please note that we have updated the SAE form to version 2. Please use Version 2 from 01 August 2009
Lab normal ranges - v1.0
- last updated 10 February 2009
Pharmacy (15)
Pharmacy Manual - v1.4
- last updated 02 August 2010
Information for pharmacists regarding study drugs, supply, storage, documentation etc.
Prescription - v1.0
- last updated 26 November 2008
Study precription form for imatinib and dasatinib.
Study Drug Accoubtability Log - v1.0
- last updated 15 July 2008
Study drug dispensing and returns record log
Imatinib - SMPC
- last updated 13 April 2007
Dasatinib - manufacturers authorisation - v2.0
- last updated 13 June 2006
Please contact the Trial Office for a copy of the document above.
Dasatinib - QP declaration
- last updated 13 October 2008
Please contact the Trial Office for a copy of the document above.
Dasatinib - Licence 1595 cover page
- last updated 08 July 2005
Please contact the Trial Office for a copy of the document above.
Dasatinib - label - 20mg tablets
- last updated 07 August 2009
Please contact the Trial Office for a copy of the document above.
Dasatinib - label - 50mg tablets
- last updated 07 August 2009
Please contact the Trial Office for a copy of the document above.
Dasatinib - trial-specific label
- last updated 01 August 2008
Please contact the Trial Office for a copy of the document above.
Imatinib - label
- last updated 07 August 2009
Dasatinib Order Form
- last updated 21 July 2009
Study Drug Receipt Log - v1.0
- last updated 20 January 2009
Dasatanib UDE Certificate 20mg and UDE certificate 50mg
- last updated 24 June 2009
Please contact the Trial Office for a copy of the document above.
Dasatanib TSE Certificate
- last updated 16 June 2009
Please contact the Trial Office for a copy of the document above.
MHRA (21)
CTA approval
- last updated 22 April 2008
Contains 3 letters from MHRA (1)acknowledgment of CTA application, (2)Request for further information (3)CTA approval letter
CTA application - Annex 1 - unsigned
- last updated 11 February 2008
CTA application - Annex 1 - signature page
- last updated 11 February 2008
EUDRACT receipt
- last updated
CTA application covering letter
- last updated 20 February 2008
Response to MHRA request for further information
- last updated 11 April 2008
Cover letter sent to MHRA in response to request for further information regarding the manufacture of dasatinib. Documents relating to the study drugs can be found under the Pharmacy section.
Applicant authorisation from Sponsor
- last updated 12 February 2008
Dasatinib IMPD cross reference letter
- last updated 07 August 2009
Please contact the Trial Office for the above document. Letter from BMS to MHRA stating that information previously submitted to support CTA applications for other trials using dasatinib can be used for this application.
List of Sponsor's trials using IMP
- last updated
List of active trials being run by the same Sponsor (Newcastle-upon-Tyne NHS Hospitals Foundation Trust) involving either IMP.
Amendment 1 - Cover letter
- last updated 02 May 2008
Amendment 1 was approved before any site was opened for recruitment. Hence only the amended versions of the documents concerned (Protocol and PIL/IC form)are available under the Study Conduct section.
Amendment 1 - Annex 1 Form - Changes
- last updated
Original Annex 1 Form pages with sections changed due to Amendment 1 highlighted
Amendment 1 - Annex 1 Form - Updated
- last updated
Amendment 1 - Substantial Amendment Notification
- last updated 11 April 2008
Amendment 1 - Supporting Information
- last updated
Copy of letter responding to CTAAC reviewers comments. The changes requested by the CTAAC committee prompted Amendment 1.
Amendment 1 - MHRA Approval
- last updated 10 June 2008
Amendment IB Dasatinib Version 8 - cover letter
- last updated 19 December 2008
Amendment IB Dasatinib Version 8 - Substantial Amendment Notification
- last updated 19 December 2008
Amendment IB Dasatinib Version 8 - MHRA Approval
- last updated 09 January 2009
Dasatinib Label - Substantial Amendment Notification
- last updated 10 August 2009
Dasatinib Label Amendment- MHRA Approval
- last updated 10 September 2009
Annual Safety Report 2008 - 2009
- last updated 21 May 2009
Ethics (14)
NRES application form - unsigned
- last updated 07 November 2007
NRES Application - signature pages
- last updated 07 November 2007
Covering Letter to MREC 07 Nov 2007
- last updated 07 November 2007
Response to Questions from MREC
- last updated 22 January 2008
Favourable Ethical Opinion
- last updated 18 February 2008
Amendment 1 - cover letter
- last updated 14 April 2008
Amendment 1 was approved before any site was opened for recruitment. Hence only the amended versions of the documents concerned (Protocol and PIL/IC form)are available under the Study Conduct section.
Amendment 1 - Favourable Ethical Opinion
- last updated 19 June 2009
Amendment IB Dasatinib Version 8 - Cover Letter
- last updated 19 December 2008
Amendment IB Dasatinib Version 8 - Favourable Ethical Opinion
- last updated 15 January 2009
Amendment IB Dasatinib Version 8 - Response to Question from main REC
- last updated 15 January 2009
Dasatinib Label Amendment 1 - MREC Cover Letter
- last updated 10 July 2009
Dasatinib Label Amendment 1 - MREC Approval
- last updated 25 August 2009
Dasatinib Label Amendment 2 - MREC Approval
- last updated 11 January 2010
Dasatinib Label Amendment 2 - MREC Cover Letter
- last updated 02 December 2009
Sponsor (4)
Clinical Trial Agreement - v1.0
- last updated 05 July 2010
Please complete the sections highlighted in red for your site and return two signed copies to the SPIRIT Trial Manager. One fully signed copy will then be returned to you.
Confirmation of EUCTD Sponsor
- last updated
Sponsor indemnity and insurance
- last updated
Chief Investigator CV
- last updated 29 October 2007
Presentations (4)
NCRI CML WG May 2008
- last updated
NCRI CML Working Group presentation given at Annual Review of Leukaemia meeting in May 2008. Includes preliminary high-level results from SPIRIT 1 study and an overview of the SPIRIT 2 Study.
CML abstracts & notes - ASH 2008
- last updated
CML abstracts & notes - ASH 2009
- last updated 02 February 2010
Site Initiation
- last updated 16 April 2010
Patients (0)
UK and Ireland Symposium on Chronic Myeloid Leukaemia 7th May 10 (1)
Draft Agenda and Registration Form
- last updated 18 February 2010
CML 8th National Patient and Carer Education Day 14th Nov 09 (2)
CML 8th National Patient and Carer Education Day Poster
- last updated 28 August 2009
CML 8th National Patient and Carer Education Day Leaflet
- last updated 28 August 2009