MRC Clinical Trials Unit at UCL
2nd Floor
90 High Holborn
London
WC1V 6LJ
Email: mrcctu.stampede@ucl.ac.uk
Superseded Essential Documents
All of the following documents have been superseded from STAMPEDE and are here for reference only. Please refer to the Current Essential Documents for those to be used in the running of the trial.
Superseded Protocols & Appendices
- V2.0 (Jun 2005)
- V3.0 (Jul 2006)
- V4.0 (Dec 2007)
- V5.0 (Aug 2008)
- V6.0 (Jul 2009) & Appendices V5.0 (Aug 2008)
- V7.1 (Jun 2011) & Appendices V6.0 (Jul 2009) & File Note 7.1
- V8.0 (Sep 2011) & Appendices V7.0 (Jun 2011)
- V9.0 (Oct 2012) & Appendices V8.0 (Sep 2011)
- V10.0 (Apr 2013) & Appendices V9.0 (Oct 2012)
- V11.0 (Sep 2013) & Appendices V10.0 (Apr 2013)
- V12.0 (Jan 2014) & Appendices V11.0 (Jan 2014)
- V13.0 (Feb 2015) & Appendices V12.0 (Feb 2015)
- V14.0 (Oct 2015) & Appendices V13.0 (Oct 2015)
- V15.0 (Mar 2016) & Appendices V14.0 (Mar 2016)
- V16.0 (Mar 2017) & Appendices V15.0 (Mar 2017)
- V17.0 (Oct 2017) & Appendices V16.0 (Oct 2017)
- V19.0 (June 2018) & Appendices V18.0 (June 2018)
- V20.0 (August 2020)
- Protocol V21.0 Clean (October 2020) & Appendices V19.0 Clean (August 2020)
Superseded Patient Information Statements
PIS General
- PIS General V1.0 (Aug 2004)
- PIS General V2.0 (Jun 2005)
- PIS General V3.0 (Jul 2006)
- PIS General V4.0 (Dec 2007)
- PIS General V5.0 (Aug 2008)
- PIS General V6.0 (Jul 2009)
- PIS General V7.0 (Apr 2011)
- PIS General V8.0 (Sep 2011)
- PIS General Part 1 V9.0 (Oct 2012)
- PIS General Part 2 V9.0 (Oct 2012)
- PIS General Part 1 V10.0 (Apr 2013)
- PIS General Part 2 V10.0 (Apr 2013)
- PIS General Part 1 V10.1 (Feb 2014)
- PIS General Part 1 V11.0 (Jan 2014)
- PIS General Part 2 V11.0 (Sep 2013)
- PIS General Part 1 V12.0
- PIS General Part 2 V12.0 (May 2014)
- PIS General Part 1 V13.0
- PIS General Part 2 V13.0
- PIS General Part 1 V14.0 (Mar 2016)
- PIS General Part 2 V14.0
- PIS General Part 1 V15.0 (Jul 2016)
- PIS General Part 2 V15.0 (Mar 2016)
- PIS General Part 2 V16.0 (Jul 2016)
- PIS General - Part 1 V16.0 (Mar 2017)
- PIS General - Part 2 V17.0 (Mar 2017)
- PIS General Part 1 & 2 V18.0 (June 2018)
- PIS General Part 1 & 2 V19.0 (Sept 2019)
Arm A
- PIS Arm A V1.0 (May 2004)
- PIS Arm A V2.0 (Jun 2005)
- PIS Arm A V3.0 (Jul 2006)
- PIS Arm A V4.0 (Dec 2007)
- PIS Arm A V5.0 (Aug 2008)
- PIS Arm A V6.0 (Jul 2009)
- PIS Arm A V8.0 (Sep 2011)
- PIS Arm A V9.0 (Oct 2012)
- PIS Arm A V10.0
- PIS Arm A V11.0 (Mar 2016)
- PIS Arm A V12.0 (Mar 2017)
- PIS Arm A V13.0 (Sept 2019)
Arm B
- PIS Arm B V1.0 (May 2004)
- PIS Arm B V2.0 (Jun 2005)
- PIS Arm B V3.0 (Jul 2006)
- PIS Arm B V4.0 (Dec 2007)
- PIS Arm B V5.0 (Aug 2008)
- PIS Arm B V6.0 (Jul 2009)
- PIS Arm B V8.0 (Sep 2011)
- PIS Arm B V9.0 (0ct 2012)
- PIS Arm B V10.0 - Final (Feb 2014)
Arm C
- PIS Arm C V1.0 (May 2004)
- PIS Arm C V2.0 (Jun 2005)
- PIS Arm C V3.0 (Jul 2006)
- PIS Arm C V4.0 (Dec 2007)
- PIS Arm C V5.0 (Aug 2008)
- PIS Arm C V6.0 (Jul 2009)
- PIS Arm C V8.0 (Sep 2011)
- PIS Arm C V9.0 - Final (Oct 2012)
Arm D
- PIS Arm D V1.0 (May 2004)
- PIS Arm D V2.0 (Jun 2005)
- PIS Arm D V3.0 (Jul 2006)
- PIS Arm D V4.0 (Dec 2007)
- PIS Arm D V5.0 (Aug 2008)
- PIS Arm D V6.0 - Final (Jul 2009)
Arm E
- PIS Arm E V1.0 (May 2004)
- PIS Arm E V2.0 (Jun 2005)
- PIS Arm E V3.0 (Jul 2006)
- PIS Arm E V4.0 (Dec 2007)
- PIS Arm E V5.0 (Aug 2008)
- PIS Arm E V6.0 (Jul 2009)
- PIS Arm E V8.0 (Sep 2011)
- PIS Arm E V9.0 (Oct 2012)
- PIS Arm E V10.0 - Final (Feb 2014)
Arm F
- PIS Arm F V1.0 (May 2004)
- PIS Arm F V2.0 (Jun 2005)
- PIS Arm F V3.0 (Jul 2006)
- PIS Arm F V4.0 (Dec 2007)
- PIS Arm F V5.0 (Aug 2008)
- PIS Arm F V6.0 - Final (Jul 2009)
Arm G
Arm H
Arm J
Arm K
Arm L
- PIS Arm L V1.0 (Mar 2017)
- PIS Arm L V3.0 (July 2018)
- PIS Arm L V4.0 (Sept 2019)
- PIS General Part 3 Arm L V5.0 (August 2020)
Additional Research
- PIS Additional Research V2.0
- PIS Additional Research V3.0 (Jul 2006)
- PIS Additional Research V4.0 Type A (Dec 2007)
- PIS Additional Research V4.0 Type B (Dec 2007)
- PIS Additional Research V5.0 Type A (Aug 2008)
- PIS Additional Research V5.0 Type B (Aug 2008)
- PIS Additional Research V6.0 Type A (Jul 2009)
- PIS Additional Research V6.0 Type B (Jul 2009)
- PIS Additional Research V8.0 Type A (Sep 2011)
- PIS Additional Research V8.0 Type B (Sep 2011)
- PIS Additional Research V9.0 (Oct 2012)
- PIS Additional Research V10.0 (Feb 2015)
- PIS Additional Research V11.0 (Jun 2015)
- PIS Additional Research V12.0
- PIS Additional Research V13.0
- PIS Additional Research V14.0
Superseded Consent Forms
STAMPEDE
- Consent Form V1.0 (Aug 2004)
- Consent Form V2.0 (Jun 2005)
- Consent Form V3.0 (Jul 2006)
- Consent Form V4.0 Type A (Dec 2007)
- Consent Form V4.0 Type B (Dec 2007)
- Consent Form V5.0 Type A (Aug 2008)
- Consent Form V5.0 Type B (Aug 2008)
- Consent Form V6.0 Type A (Jul 2009)
- Consent Form V6.0 Type B (Jul 2009)
- Consent Form V8.0 Type A (Sep 2011)
- Consent Form V8.0 Type B (Sep 2011)
- Consent Form V9.0 (Oct 2012)
- Consent Form V10.0 (Apr 2013)
- Consent Form V11.0 (Sep 2013)
- Consent Form V12.0 (Feb 2015)
- Consent Form V13.0 (Oct 2015)
- Consent Form V14.0 (Feb 2016)
- Consent Form V15.0 (Mar 2016)
- Consent Form V16.0 (Mar 2017)
- Consent Form V18.0 (July 2018)
- Consent Form V19.0 (Sept 2019)
Additional Research
- Additional Research Consent Form V1.0 (Feb 2016)
- Additional Research Consent Form V2.0 (Mar 2017)
- Additional Research Consent Form V3.0 (Oct 2017)
Superseded Letters
- GP Letter STAMPEDE Enrolment Version 15.0
- GP Letter STAMPEDE Enrolment Version 14.0
- GP Letter STAMPEDE Enrolment Version 13.0
- GP Letter STAMPEDE Enrolment Version 12.0
- GP Letter STAMPEDE Enrolment Version 11.0
- GP Letter STAMPEDE Enrolment Version 10.0
- GP Letter STAMPEDE Enrolment Version 9.0
- GP Letter STAMPEDE Enrolment Version 8.1
- GP Letter STAMPEDE Enrolment Version 8.0
- GP Letter STAMPEDE Enrolment Version 7.0
- GP Letter STAMPEDE Enrolment Version 6.0
- GP Letter STAMPEDE Enrolment Version 5.0
- GP Letter STAMPEDE Enrolment Version 4.0
- GP Letter STAMPEDE Enrolment Version 3.0
- GP Letter STAMPEDE Enrolment Version 2.0
- GP Letter STAMPEDE Enrolment Version 16.0 (Mar 2017)
- GP Letter Diabetes Mellitus Version 1.0 (Mar 2016)
- Zoledronic Acid Letter (31JAN2014)
- UCL Administrative Changes (16SEP13)
Superseded Other Documents
- MRC Indemnity Statement
- Insurance Certificate 2013 - 2014
- Insurance Certificate 2014 - 2015
- Insurance Certificate 2015 - 2016
- Insurance Certificate 2016 - 2017
- Insurance Certificate 2017 - 2018
- Insurance Certificate 2018 - 2019
- Insurance Certificate 2019 - 2020
- Sponsorship Letter (Apr 2004)
Original Comparison
All sites were sent a personalised email and a pack in the post for "Comparison Closure" describing the necessary actions to take at site and providing site specific tools to assist with the closure process. Please find below the link to the checklist used to provide sign off to the STAMPEDE team of actions completed at site.
The activities surrounding comparison closure should only be enacted once your site has received the Green Light to protocol version 19.0.
- Comparison Closure Checklist v1.0
- Comparison Closure - Participants Stopping Follow-up
- Comparison Closure - Participants Continuing Follow-up
STAMPEDE