MRC Clinical Trials Unit at UCL
2nd Floor
90 High Holborn
London
WC1V 6LJ
Email: mrcctu.stampede@ucl.ac.uk
Ethics & Regulatory
Amendment - RSI 2023-2024
- HRA Amendment Tool (21-Aug-2023)
- HRA-HCRW RSI 2023-2024 Approval (29-Sep-2023)
- MHRA Cover Letter (21-Aug-2023)
- HRA Cover Letter (21-Aug-2023)
- MHRA RSI 2023-2024 Notice of Acceptance of Amendment (26-Sep-2023)
- Please refer to our RSI webpage for SmPCs/IBs relevant to this amendment (login required)
Amendment - RSI 2022-2023
- HRA Amendment Tool 08-Sep-2022
- HRA-HCRW RSI 2022-2023 approval 01-Nov-2022
- MHRA Cover Letter 08-Sep-2022
- MHRA RSI 2022-2023 Notice of acceptance of Amendment 11-Oct-2022
- Please refer to our RSI webpage for SmPCs/IBs relevant to this amendment (login required)
Amendment - Metformin Treatment Pause (November 2021)
- REC Cover Letter (18-Nov-2021)
- REC Letter of Favourable Opinion (10-Dec-2021)
- Amendment Tool (18-Nov-2021)
- HRA Approval (24-Dec-2021)
Amendment – Abiraterone IB Edition 15 (March 2021)
- MHRA Approval (08-Apr-2021)
- MHRA Acknowledgement of Amendment (09-Mar-2021)
- MHRA Cover Letter (04-Mar-2021)
- Annex II form (02-Mar-2021)
- HRA Approval Email (10-Mar-2021)
- HRA Amendment Tool (02-Mar-2021)
- REC Cover Letter (04-Mar-2021)
- Please refer to our RSI webpage for SmPCs/IBs relevant to this amendment (login required)
Amendment - IRAS Submission (July 2020)
- IRAS Cover Letter (27-Jul-2020)
- IRAS Form (28-Jul-2020)
- HRA Email - no approval required (12-Aug-2020)
Amendment - New Clinical Trial Authorisation (July 2020)
- MHRA Cover Letter (30-Jul-2020)
- Annex II Form (30-Jul-2020)
- STAMPEDE CTA (28-Jul-2020)
- STAMPEDE DDX Approval (05-Apr-2004)
- MHRA Approval (07-Aug-2020)
- REC/HRA approval not required as CTA questions included in IRAS submission
Amendment - Enzalutamide IB (RSI) (July 2020)
- MHRA Approval (25-Sep-20)
- MHRA Notice of Non-Acceptance (20-Aug-20)
- MHRA Cover Letter (16-Jul-20) - 1st submission (This document was also sent to REC)
- MHRA Cover Letter (21-Aug-20) - 2nd submission
- Annex II Form (16-Jul-20)
- HRA Amendment Tool (16-Jul-20)
- REC Cover Letter (16-Jul-20)
- REC Approval (28-Jul-20)
- HRA Approval email (28-Jul-20)
- Please refer to our RSI webpage for SmPCs/IBs relevant to this amendment (login required)
Amendment - Degarelix SPC (RSI) (April 2020)
- MHRA Approval (04-Jun-20)
- MHRA Cover Letter (30-Apr-20)
- Annex II Form (30-Apr-20)
- REC Approval (01-Jul-20)
- REC Cover Letter (30-Apr-20) (This document was also sent to the MHRA)
- HRA No approval required (email) (07-May-20)
- Summary Non-Substantial Amendment (COVID-19) v1.0
- Please refer to our RSI webpage for SmPCs/IBs relevant to this amendment (login required)
Amendment - IMP labels (February 2020)
- MHRA Approval (24-Feb-20)
- MHRA Cover Letter (18-Jan-20)
- Annex II Form (18-Feb-20)
- REC Approval (23-Apr-20)
- HRA Approval (23-Apr-20)
- REC Cover Letter (18-Jan-20) (This document was also sent to the MHRA)
- Please refer to Pharmacy Essential Documents for IMP labels relevant to this amendment (login required)
Amendment - Change of Sponsor, PIS update following Arm K pause, and RSI 2019-2020
REC and HRA (Change of Sponsor, PIS update, RSI update):
- HRA Approval (06-Nov-2019)
- HRA Categorisation Email (07-Oct-2019)
- REC Approval (23-Oct-2019)
- REC Cover Letter (01-Oct-2019)
- Substantial Amendment Notification Form (01-Oct-2019)
MHRA (Change of Sponsor):
- MHRA Approval (24-Apr-2019)
- MHRA Cover Letter (11-Apr-2019)
- Substantial Amendment Notification Form (05-Mar-2019)
MHRA (RSI update):
- HRA Approval (14-Feb-2020)
- MHRA Approval (04-Nov-2019)
- MHRA Cover Letter - Clarification Post-Submission (28-Oct-2019)
- MHRA Summary Table for RSI for DSUR 17-Oct2019 to 16-Oct-2020 (28-Oct-2019)
- MHRA Cover Letter (30-Sep-2019)
- Substantial Amendment Notification Form (30-Sep-2019)
- Please refer to our RSI webpage for SmPCs/IBs relevant to this amendment (login required)
Amendment - Hormone Patch Application Information Sheet v1.0
- HRA Approval (03-Sept-2019)
- HRA Categorisation Email (12-Aug-2019)
- REC Approval (19-Aug-2019)
- REC Cover Letter (06-Aug-2019)
- REC Submission Form (06-Aug-2019)
- MHRA Approval not required
Amendment - Consent Form v19.0 and PIS General v19.0, PIS Arm A v13.0, PIS Arm L v4.0
- HRA Approval (06-Nov-2019)
- HRA Categorisation Email (07-Oct-2019)
- REC Approval (23-Oct-2019)
- REC Cover Letter (01-Oct-2019)
- REC Submission Form (01-Oct-2019)
- MHRA Approval not required
Protocol Version 19.0
- REC Approval (01-Oct-2018)
- REC Cover Letter (21-Sep-2018)
- MHRA Approval (12-Oct-2018)
- MHRA Cover Letter (10-Sep-2018)
- MHRA / REC Submission Form (21-Sep-2018)
- HRA Approval (15-Oct-2018)
- Manufacturer Authorisation IMP Licence - ALMAC
Amendment - Enzalutamide IB Version 9.0
- MHRA Approval (09-May-2018)
- MHRA Cover Letter (29-Mar-2018)
- MHRA Submission Form (27-Mar-2018)
- HRA Approval (27-Mar-2018)
Protocol Version 17.0
- REC Approval (13-Nov-2017)
- REC Cover Letter (18-Oct-2017)
- MHRA Approval (23-Nov-2017)
- MHRA Cover Letter (18-Oct-2017)
- Version 16-17 Clarification Email (12-Dec-2017)
- MHRA / REC Submission Form (18-Oct-2017)
- HRA Approval (27-Nov-2017)
Amendment - Abiraterone Lay Summary
Protocol Version 16.0
- REC Approval (28-Mar-2017)
- REC Cover Letter (08-Mar-2017)
- MHRA Approval (14-Mar-2017)
- MHRA Cover Letter (08-Mar-2017)
- MHRA / REC Submission Form (09-Mar-2017)
- HRA Approval (29-Mar-2017)
Amendment - End of Arm H
Protocol Version 15.0
- REC Approval (12-Apr-2016)
- REC Cover Letter (29-Mar-2016)
- MHRA Approval (25-Apr-2016)
- MHRA Cover Letter (29-Mar-2016)
- MHRA /REC Submission Form (29-Mar-2016)
- HRA Approval (12-Apr-2016)
Amendment - End of Arm J
Protocol Version 14.0
- REC Approval (20-Nov-2015)
- REC Cover Letter (30-Oct-2015)
- MHRA Approval (24-Nov-2015)
- MHRA Cover Letter (30-Oct-2015)
- MHRA / REC Submission Form (30-Oct-2015)
Amendment - Patient Letter
Amendment - Original Comparison Summary & Additional Research PIS
Protocol Version 13.0
- REC Approval (12-Mar-2015)
- REC Cover Letter (14-Feb-2015)
- MHRA Approval (23-Feb-2015)
- MHRA Cover Letter (14-Feb-2015)
- MHRA / REC Submission Form (14-Feb-2015)
Amendment - End of Arm G
Protocol Version 12.0
- REC Approval Part II (24-04-2013)
- REC Approval Part I (06-Feb-2014)
- REC Cover Letter (13-Jan-2014)
- MHRA Approval (17-Apr-2014)
- MHRA Cover Letter #2 (25-Mar-2014)
- MHRA / REC Submission #2 (25-Mar-2014)
- MHRA Cover Letter #1 (13-Jan-2014)
- MHRA / REC Submission Form #1 (13-Jan-2014)
Amendment - PIS General
Protocol Version 11.0
- REC Approval (25-Sep-2013)
- REC Cover Letter (17-Sep-2013)
- MHRA Approval (05-Nov-2013)
- MHRA Cover Letter (01-Oct-2013)
- MHRA / REC Submission Form (17-Sep-2013)
Protocol Version 10.0
- REC Approval (30-Apr-2013)
- REC Cover Letter (27-Mar-2013)
- MHRA Approval (22-May-2013)
- MHRA Cover Letter #2 (12-Apr-2013)
- MHRA / REC Submission Form #2 (09-Apr-2013)
- MHRA Cover Letter #1 (27-Mar-2013)
- MHRA / REC Submission Form #1 (27-Mar-2013)
Protocol Version 9.0
- REC Approval (07-Nov-2012)
- REC Cover Letter (23-Oct-2012)
- MHRA Approval (29-Nov-2012)
- MHRA Cover Letter (23-Oct-2012)
- MHRA / REC Submission Form (22-Oct-2012)
Protocol Version 8.0
- REC Approval (19-Sep-2011)
- REC Cover Letter (02-Sep-2011)
- MHRA Approval (03-Oct-2011)
- MHRA Cover Letter (02-Sep-2011)
- MHRA / REC Submission Form (02-Sep-2011)
Protocol Version 7.0
Protocol Version 6.0
- REC Approval (04-Aug-2009)
- REC Cover Letter (09-Jul-2009)
- MHRA Approval (07-Aug-2009)
- MHRA Cover Letter (09-Jul-2009)
- MHRA / REC Submission Form (09-Jul-2009)
Protocol Version 5.0
- REC Approval (30-Sep-2008)
- REC Cover Letter (18-Aug-2008)
- MHRA Approval (04-Sep-2008)
- MHRA Cover Letter (08-Aug-2008)
- MHRA / REC Submission Form (01-Aug-2008)
Protocol Version 4.0
- REC Approval (28-Jan-2008)
- REC Cover Letter (12-Dec-2007)
- MHRA Approval (25-Jan-2008)
- MHRA Cover Letter (12-Dec-2007)
- MHRA / REC Submission Form (12-Dec-2007)
Protocol Version 3.0
- REC Approval (09-Aug-2006)
- REC Cover Letter (11-Jul-2006)
- MHRA Approval (01-Aug-2006)
- MHRA Cover Letter (11-Jul-2006) & MHRA / REC Submission Form (11-Jul-2006)
Protocol Version 2.0
- REC Approval (08-Jul-2005)
- REC Cover Letter (13-Jun-2005)
- MHRA Approval (15-Jun-2005)
- MHRA Cover Letter (13-Jun-2005)
- MHRA / REC Submission Form (Undated)
Initial
- REC Approval (04-Oct-2004)
- REC Cover Letter (16-May-2005)
- MHRA Approval (25-May-2005)
- MHRA Cover Letter (Undated)
- Original REC Application
- Original CTA Application - DDX Combined
STAMPEDE