Documents and Downloads
Please download any of the files below by clicking
"Download".
Study Documentation (14)
Document version control v12.0 - last updated 19 December 2011
Contact lists - last updated 29 September 2011
Contact list for Trial Office and template for completion of
local site contact details.
eCRF completion guidelines v1.0 - last updated 04 July 2011
Sorry to access this file you must be logged in and have permissions.
Protocol v1.4 - last updated 20 March 2008
Patient Information Sheet / Consent Form v1.2 - last updated 07 May 2008
GP Letter v1.0 - last updated 18 February 2008
Delegation Log v2.0 - last updated 02 December 2010
Screening Log v2.0 - last updated 11 March 2011
Site Patient Log v1.0 - last updated 27 November 2008
SAE Form v2.0 - last updated 01 August 2009
Source Data Agreement - last updated 21 November 2011
Lab normal ranges v1.0 - last updated 18 February 2008
Quality of Life questionnaires - last updated 18 February 2008
There are two files to download. The correct
questionnaires are the EQ5D (UK version dated 1990) and FACT BRM
(dated 1997).
Sorry to access this file you must be logged in and have permissions.
PCR and Biobank shipping form - last updated 19 December 2011
Sorry to access this file you must be logged in and have permissions.
Pharmacy (10)
Dasatinib sample labels ( Private category, login required. )
Document version control v12.0 - last updated 19 December 2011
Information for pharmacists v2.0 - last updated 14 October 2011
Prescription v1.0 - last updated 15 July 2008
Study precription form for imatinib and dasatinib.
Dasatinib order form v3.0 - last updated 23 June 2011
Study drug receipt log v2.0 - last updated 02 December 2010
Note this comprises two pages (1x20mg and 1x50mg pages).
Study drug destruction log v1.0 - last updated 02 December 2010
Note this comprises two pages (1x20mg and 1x50mg pages).
Study drug dispensing and return accountability log v1.0 - last updated 15 July 2008
Imatinib SmPC (file note) - last updated
File note to refer to EMC for the previous and current versions of the SmPC for imatinib.
Dasatinib Investigator Brochure - last updated 03 November 2010
Files listed are:
Version 10 (3 Nov 10)
Version 9 (3 Nov 09)
Version 8 (12 Nov 08)
Sorry to access this file you must be logged in and have permissions.
Presentations and meetings (11)
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
CML update online meeting 15 October - last updated
CML abstracts & notes - ASH 2010 - last updated
The document contains a brief summary of the key CML data released at ASH 2010, the complete abstracts for all 43 oral presentations relating to CML and a listing of all CML posters. We've tried to make it as concise as possible so that in 5 minutes over a cup of coffee you can see at a glimpse what's new.
Post ASH 2010 CML update meeting (programme) - last updated
Programme and full joining instructions for the 2010 Post ASH CML update meeting being held on Friday 17 December 2010.
ESH-ICMLF 13th International Conference CML Biology and therapy - last updated 31 March 2011
Flyer for the ESH-ICMLF CML Conference, Portugal, 22-25 September 2011.
ASH 2011 - summary presentation - last updated 16 December 2011
Slides from presentation given by Professor O'Brien following
ASH 2011 meeting.
ASH 2011 - summary report - last updated 16 December 2011
A summary of information presented at the ASH 2011 meeting
prepared by Prof O'Brien.
ASH 2011 - SPIRIT 2 presentation - last updated 16 December 2011
Presentation from SPIRIT 2 data presented at ASH 2011 in
December 2011.
Patients (0)
Ethics (5)
Ethics Original Submission - last updated 18 February 2008
Ethics Amendment (protocol v1.4) - last updated 07 May 2008
Ethics Amendment (IBv8) - last updated 15 January 2009
Ethics Amendment (first label change) - last updated 25 August 2009
Ethics Amendment (second label change) - last updated 11 January 2010
MHRA (5)
MHRA Original Submission - last updated 22 April 2008
MHRA Amendment (protocol v1.4) - last updated 10 June 2008
MHRA Amendment (IBv8) - last updated 09 January 2009
MHRA Amendment (first label change) - last updated 10 September 2009
MHRA Amendment (second label change) - last updated 12 January 2010
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 10 February 2010
CVs available 29 Oct 2007 and 10 Feb 2010.
Annual Safety Reports (7)
File note (annual safety reports) - last updated 31 January 2011
MHRA 2008/2009 - last updated 20 April 2009
MHRA 2009/2010 - last updated 21 June 2010
MREC 2008/2009 - last updated 20 April 2009
MREC 2009/2010 - last updated 08 July 2010
MHRA 2010/2011 - last updated 01 June 2011
MREC 2010/2011 - last updated 01 June 2011
SUSAR Reports (3)
IB 10 - SUSAR 03 (PID: CA180-056-46-56281) - last updated 30 June 2011
Sorry to access this file you must be logged in and have permissions.
IB 10 - SUSAR 04 (PID: CA180-227-270-71844) - last updated 02 August 2011
Sorry to access this file you must be logged in and have permissions.
IB11 - SUSAR 01 (PID CA180-227-187-71739) - last updated 21 December 2011
Please note that Investigator Brochure 11 (Dasatinib) will be
available once MHRA and MREC approval following their review.
Sorry to access this file you must be logged in and have permissions.
Newsletters (4)
November 2011 Newsletter - last updated 22 November 2011
March 2011 Newsletter - last updated 31 March 2011
November 2010 Newsletter - last updated 30 November 2010
September 2010 Newsletter - last updated 30 September 2010
SPIRIT 2 FAQs (1)
SPIRIT 2 FAQs - last updated 11 November 2011
We will publish more FAQs over time - if you have any
suggestions please
let Caroline Hodgson know! Caroline can be contacted on c.hodgson@ncl.ac.uk and would
love to hear from you.
Training (1)
eCRF completion guidelines (SPIRIT 2) v1.0 - last updated 04 July 2011
Sorry to access this file you must be logged in and have permissions.