Current Essential Documents

Current Protocol & Appendices

• STAMPEDE protocol v23 05-Oct-2021 clean
• STAMPEDE Appendices v20.0 clean

Current Patient Information Statements & Consent Form

• Participant Treatment and Additional Research Consent Form V20.0 (August 2020)
• PIS General Part 3 Arm K V5.0 (August 2020)
• Stampede Part3 arm L v6.0
• STAMPEDE EOS stop FU v1.0 July 2021
• STAMPEDE ongoing treatment G J v1.0 July2021
• PIS Additional Research V15.0 (July 2018)
• PIS General Part 1 & 2 V20.0 (August 2020)
• PIS General Part 3 Arm A V14.0 (August 2020)

 Note: Metabolic sub-study PIS will only be provided to sites participating in the sub-study.

Current GP Letters 

• STAMPEDE GP Letter v17.0 clean 

Current Patient Letters

• "Abiraterone Comparison" Results Summary Sheet (Jun-2017)
• "Original Comparisons" Results Summary Sheet (Jan-2016)
• "M1 Radiotherapy Comparison" Results Summary Sheet (Oct-2018)
• Patient Abiraterone Letter (14-Jan-2014)
• Abiraterone Pregnancy Warning Email to Sites
• Abiraterone Pregnancy Warning Letter to REC (11-Feb-2013)
• Patient Retrospective Saliva Collection Letter Version 2.0
• Metformin Treatment Pause Information Letter v1.0 (15-Nov-2021)

Current Sub studies

• Sample Collection and Handling Manual v8.0
• Pathology request letter (pdf)
• Pathology request letter (doc)

Current Other Documents

• Insurance Certificate 2020-2021
• Funding for Drug Supply
• Docetaxel Subvention Letter
• Model Clinical Trials Agreement
• Delegation Log v5.0
• Site Monitoring Log v1.0
• Site Deviations Log v2.0
• Site Deviation Working Practises v1.0
• Hormone Patch Application Sheet v1.0 (PDF)
• Hormone Patch Application Sheet v1.0 (Word)
• MRC Sponsorship Letter
• UCL Sponsorship Letter
• CTA (28-July-2020)
• CTA (19-August-2020)
• IRAS Form (28-Jul-2020)
• No Fault Compensation Insurance 2023-24
• Legal Liability Insurance 2023-24