STAMPEDE2 Amendment Update

The full amendment pack for Substantial Amendment 03 and Non-Substantial Amendment 04 is now available. Please access the password protected Essential Documents page of this website. The Substantial Amendment 03 and Non-Substantial Amendment 04 Document Pack file is located under the Regulatory/Approval Documents section of the page, under the Substantial Amendment Packs heading.
Essential Documents | Stampede2 Trial

The team have also put together a short slide set outlining the changes which should help to reduce workload at sites. This is titled Substantial Amendment 03 and Non-Substantial Amendment 04 Training, and is accessible via the same section of the Essential Documents page.

Please note it is important that your site implement these on 8th July so you can continue to seamlessly randomise patients moving from Protocol 5 to Protocol 7. Please make sure patients receive the appropriate PIS and CF in line with this change and timeline.

The trial source data worksheets will also be updated and released in July.

Thank you for all your hard working.
STAMPEDE2 Team