MRC Clinical Trials Unit at UCL
2nd Floor
90 High Holborn
London
WC1V 6LJ
Email: mrcctu.stampede@ucl.ac.uk
Protocol Version 21.0 Update Pack
Please note: All sites must have greenlight status for protocol 19 before they can activate to protocol 21. Please contact the STAMPEDE team if you require assistance with protocol 19 activation.
Please refer to the essential documents page for all current documents.
Protocol 21.0 Training for Site Staff
To book protocol training dates please refer to the Upcoming Training page (password required).
If you were unable to attend the live sessions, please refer to the site staff protocol 21 training video, found on our Training Materials & Resources page with further information.
Protocol 21.0 Training for Principal Investigators
To view the training presentation please refer to the Upcoming Training page (password required).
Updated Essential Documents
- STAMPEDE Protocol V21.0 Clean (October 2020)
- STAMPEDE Protocol V21.0 Tracked (October 2020)
- STAMPEDE Protocol V20.0 Clean (August 2020) - watermarked superseded
- STAMPEDE Protocol V20.0 Tracked (August 2020)
- STAMPEDE Appendices V19.0 Clean (August 2020)
- STAMPEDE Appendices V19.0 Tracked (August 2020)
Amendment - Protocol 21 (Non-substantial)
Amendment - Protocol 20 (Substantial)
- REC Cover Letter (20-Aug-2020)
- REC Approval (15-Sept-2020)
- MHRA Cover Letter (20-Aug-2020)
- MHRA Approval (16-Sept-2020)
- HRA Approval (22-Sept-2020)
- STAMPEDE Clinical Trial Authorisation (CTA) (19-Aug-20)
- Annex II Form Protocol 20 (20-Aug-20)
- Amendment Tool Protocol 20 (20-Aug-20)
- Section F Summary of changes (18-Aug-20)
Updated IMP Documents
Note: For IBs/SPCs submitted, please go to the reference safety information page.
New Participant Documents
- STAMPEDE PIS General Part 1 & 2 V20.0
- STAMPEDE PIS General Part 1 & 2 (Tracked) V20.0
- STAMPEDE PIS Part 3 ARM A V14.0
- STAMPEDE PIS Part 3 ARM A (Tracked) V14.0
- STAMPEDE PIS Part 3 ARM K V5.0
- STAMPEDE PIS Part 3 ARM K (Tracked) V5.0
- STAMPEDE PIS Part 3 ARM L V5.0
- STAMPEDE PIS Part 3 ARM L (Tracked) V5.0
- STAMPEDE Participant Treatment and Additional Research Consent Form V20.0
- STAMPEDE Participant Treatment and Additional Research Consent Form (Tracked) V20.0
Note: Metabolic sub-study PIS will only be provided to sites participating in the sub-study.
Activation Documents
- Activation Checklist (Protocol 21)
- PI Amendment Acknowledgment (Protocol 21)
- Research Team Amendment Acknowledgment (Protocol 21)
- Pharmacy Amendment Acknowledgment (Protocol 21)
- ISF checklist – Oct-2020
- PSF Checklist – Oct-2020
- Investigator Statement (Protocol version 21)
- Variation to CTA (new sponsor, imaging, courier costs and metabolic sub study)
- Restarting to recruitment COVID-19 feasibility checklist
- Source Data Identification Log (version 1.0)
- Self-Evident Corrections (SECs) v2.0
- PI Confirmation of SUSAR line listing reports 17-Jul-2019 to 16-Jul-2020
- Training Log v2.0
- Delegation Log v5.0
- Site Deviations Log v2.0
- Site Deviation Working Practises v1.0 (to be used alongside log above)
M1RT Comparison Closure
STAMPEDE