MRC Clinical Trials Unit at UCL
2nd Floor
90 High Holborn
London
WC1V 6LJ
Email: mrcctu.stampede@ucl.ac.uk
Protocol 23.0 Amendment Pack
Please note: All sites must have greenlight status for protocol 21 before they can activate to protocol 23. Please contact the STAMPEDE team if you require assistance with protocol 21 activation.
Please refer to the essential documents page for all current documents.
Protocol 23.0 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 23 training video, found on our Training Materials & Resources page with further information.
Updated Essential Documents
- STAMPEDE protocol v23 05-Oct-2021 clean
- STAMPEDE protocol v23 05-Oct-2021 Tracked changes
- STAMPEDE protocol v22.0 29-July-2021
- STAMPEDE protocol v22.0 29-July-2021 Tracked
- STAMPEDE Appendices v20.0 clean
- STAMPEDE Appendices v20.0 Tracked
Amendment - Protocol 23 (Non-substantial)
- Cover Letter HRA Protocol v23.0 v1.0
- Protocol 23.0 Amendment Tool v1 5 25Mar21
- HRA Protocol 23.0 Amendment-No approval needed
Amendment - Protocol 22 (Substantial)
- Cover Letter MHRA Protocol v22.0
- MHRA Notice of acceptance of Amendment
- Cover Letter_REC_Protocol v22.0
- REC Fav opinion of a substantial amendment v22.0
- HRA Approval v22.0
- Amendment Tool v1.5 03-Aug-2021
- CTA to MHRA_243856_03-Aug-2021
Updated IMP Documents
Note: For IBs/SPCs submitted, please go to the reference safety information page.
New Participant Documents
- STAMPEDE GP Letter v17.0 clean
- STAMPEDE GP Letter v17.0 tracked
- STAMPEDE GP Letter 1 v17.0 (word)
- Stampede pis part3 arm L v6.0
- Stampede pis part3 arm L v6.0 tracked
- stampede pis part3 arm L v6.0 (word)
Activation Documents
- STAMPEDE Activation Checklist Protocol v23 v1.0
- PRINCIPAL INVESTIGATOR STATEMENT Protocol v23
- STAMPEDE PI acknowledgment Protocol v23
- STAMPEDE RT Acknowledgment Protocol v23
- STAMPEDE Investigator Site File Self Assessment Form_Nov2021_v1.0
- Self-Evident Corrections (SECs) v3.0
Abiraterone and Abi/Enza Comparison Closure
STAMPEDE