Case Report Forms

Guidance

All CRFs were updated for the activation of Protocol 23, with the exception of:

• PR08 Form 7D: Metformin Treatment Form V3.0 (October 2020)
• PR08 Form 18: Saliva Pathology Form V14.0 (Jun 2018)
• PR08 Form 13: EQ5D Health Economics Form V12.0 (Nov 2018)
• PR08 Form 13: Quality of Life Form and Health Economics V11.0 (Nov 2017)
• PR08 Form 8: Progression Log V14.0 (October 2020)
• PR08 Form 15: Co-Enrolment Form V V14.0 (October 2020)
• PR08 Form 21: SOC Systemic Therapy V5.0 (October 2020)
• PR08 Form 23:Tissue Sample Form V6.0 (October 2020)
• PR08 Form 25: Transdermal Oestradiol Treatment Log V3.0 (October 2020)
• PR08 Form 26: Metabolic Sub-Study Sample Form V1.0 (October 2020)

The following CRFs are no longer in use from Protocol 23 onwards:

• PR08 Form 13: EQ5D Health Economics Form V12.0 (November 2018)
• PR08 Form 13: Quality of Life Form and Health Economics V11.0 (November 2017)
• PR08 Form 7C: Abiraterone and Enzalutamide Treatment Log V4.0 (October 2020)
• PR08 Form 22: Blood Form V6.0 (October 2020)

Please refer to the CRF Version History V4.0 document below for guidance on which version of the CRFs should be used.

 

Current Case Report Forms

 

CRF Version History v4.0

CRF Completion Guidelines v9.0

SAE CRF Completion Guidelines v1.0

18-AUG-2022 onwards

• PR08 Form 7: Follow up Form V19.0 (August 2022)
• PR08 Form 7: Follow Up Form V19.0 (August 2022) (Without toxicity)
• PR08 Form 24: Hormone Results Log V5.0 (August 2022)

22-FEB-2022 onwards

• PR08 Form 1: Randomisation Form V19.0 (February 2022)
• PR08 Form 1A: Eligibility Checklist V5.0 (February 2022)
• PR08 Form 7B: SOC Hormone Therapy Log V6.0 (February 2022)
• PR08 Form 7D: Metformin Treatment Form V3.0 (October 2020)
• PR08 Form 7E: Toxicity Form V5.0 (February 2022)
• PR08 Form 8: Progression Log V14.0 (October 2020)
• PR08 Form 8A: Additional Treatment Log V16.0 (February 2022)
• PR08 Form 9A: Radiotherapy Detail V16.0 (February 2022)
• PR08 Form 11: End of Research Treatment V15.0 (February 2022)
• PR08 Form 12: Death Form V15.0 (February 2022) 
• PR08 Form 14: SAE Reporting Form V17.0 (February 2022)
• PR08 Form 15: Co-enrolment Form V14.0 (October 2020)
• PR08 Form 18: Saliva Pathology Form V14.0 (Jun 2018)
• PR08 Form 21: SOC Systemic Therapy V5.0 (October 2020)
• PR08 Form 23: Tissue Sample Form V6.0 (October 2020)
• PR08 Form 25: Transdermal Oestradiol Treatment Log V3.0 (October 2020)
• PR08 Form 26: Metabolic Sub-study Sample Form V1.0 (October 2020)
• Patient Transfer Form V2.0 (Nov 2014)
• STAMPEDE Guidance on long-term follow-up and end of trial participation

 

Superseded Case Report Forms

CRF Version History v1.0

CRF Version History v2.0

CRF Version History v3.0

 

21-FEB-2022 - 17-AUG-2022

• PR08 Form 7: Follow up Form V18.0 (February 2022)
• PR08 Form 7: Follow Up Form V18.0 (February 2022) (Without toxicity)
• PR08 Form 24: Hormone Results Log V4.0 (February 2022)

30-Nov-2020 - 21-FEB-2022

• PR08 Form 1: Randomisation Form V18.0 (October 2020)
• PR08 Form 1A: Eligibility Checklist V4.0 (October 2020)
• PR08 Form 7: Follow up Form V17.0 (October 2020)
• PR08 Form 7: Follow Up Form V17.0 (October 2020) (Without toxicity)
• PR08 Form 7B: SOC Hormone Therapy Log V5.0 (October 2020)
• PR08 Form 7C: Abiraterone and Enzalutamide Treatment Log V4.0 (October 2020)
• PR08 Form 7E: Toxicity Form V4.0 (October 2020)
• PR08 Form 8A: Additional Treatment Log V15.0 (October 2020)
• PR08 Form 9A: Radiotherapy Detail V15.0 (October 2020)
• PR08 Form 11: End of Research Treatment V14.0 (October 2020)
• PR08 Form 12: Death Form V14.0 (October 2020)
• PR08 Form 13: EQ5D Health Economics Form V12.0 (Nov 2018) - (Arms H & Contemporaneous A randomised after 01APR2016 only)
• PR08 Form 13: Quality of Life Form and Health economics V11.0 (Nov 2017)
• PR08 Form 14: SAE Reporting Form V16.0 (October 2020)
• PR08 Form 22: Blood Form V6.0 (October 2020)
• PR08 Form 24: Hormone Results Log V3.0 (October 2020)

 

26-NOV-2018 - 29-Nov-2020

• PR08 Form 0: Eligibility Checklist V3.0 (October 2018)
• PR08 Form 1: Randomisation Form V17.0 (June 2018)
• PR08 Form 2: Baseline Assessments Forms V15.0 (June 2018)
• PR08 Form 7: Follow Up Form V16.0 (June 2018)
• PR08 Form 7: Follow Up Form V16.0 (June 2018) (Without Toxicity)
• PR08 Form 7B: SOC Hormone Therapy Log V4.0 (June 2018)
• PR08 Form 7C: Abiraterone and Enzalutamide Treatment Form V3.0 (June 2018)
• PR08 Form 7D: Metformin Treatment Form V2.0 (June 2018) 
• PR08 Form 7E: Toxicity Form V3.0 (March 2018)
• PR08 Form 8: Progression Log V13.0 (June 2018) 
• PR08 Form 8A: Additional Treatment Log V14.0 (November 2018)
• PR08 Form 9A: Radiotherapy Detail Form V14.0 (June 2018)
• PR08 Form 9B: Radiotherapy Acute Toxicity Form V13.0 (June 2018)
• PR08 Form 11: End of Research Treatment Form V13.0 (June 2018)
• PR08 Form 12: Death Form V13.0 (July 2018) Updated version due to an error in the numbered responses within question 7
• PR08 Form 14: SAE Reporting Form V15.0 (July 2018)
• PR08 Form 15: Co-enrolment Form V13.0 (June 2018)
• PR08 Form 18: Saliva Pathology Form V14.0 (Jun 2018)
• PR08 Form 21: SOC Docetaxel Form V4.0 (June 2018) - Replaced by SOC Systemic Therapy Form from Protocol 21
• PR08 Form 22: Blood Form V5.0 (November 2018) 
• PR08 Form 23: Tissue Sample Form V5.0 (Jun 2018)
• PR08 Form 24: Hormone Results Log V2.0 (June 2018)
• PR08 Form 25: Transdermal Oestradiol Treatment Log V2.0 (October 2018) 

 

 05-JAN-2018 - 25-NOV-2018

• Current CRF Versions v3.0
• Eligibility and Screening Checklist V2.0 (Jun 2017)
• PR08 Form 1: Randomisation Form V16.0 (Dec 2017)
• PR08 Form 2: Baseline Assessment Forms V14.0 (Dec 2017)
• PR08 Form 7: Follow Up Form V15.0 (Dec 2017)     
• PR08 Form 7: Follow Up Form V15.0 (Dec 2017) (Without Toxicity) 
• PR08 Form 7E: Toxicity Form V2.0 (Jun 2017)
• PR08 Form 7B: SOC Hormone Therapy Log V3.0 (Jun 2017)
• PR08 Form 7C: Abiraterone and Enzalutamide Treatment Log V2.0 (Aug 2016)
• PR08 Form 7D: Metformin Treatment Log V1.0 (Aug 2016)
• PR08 Form 8: Progression Log V12.0 (Jun 2017)
• PR08 Form 8A: Additional Treatment Log V13.0 (Jun 2017)
• PR08 Form 9A: Radiotherapy Detail Form V13.0 (Jun 2017)
• PR08 Form 9B: Radiotherapy Acute Toxicity Form V12.0 (Jun 2017)
• PR08 Form 11: End of Research Treatment Form V12.0 (Jun 2017)
• PR08 Form 12: Death Form V12.0 (Jun 2017)
• PR08 Form 13: Quality of Life Form and Health Economics V10.0 (Jun 2017)
• PR08 Form 14: SAE Reporting Form V14.0 (Dec 2017)
• PR08 Form 15: Co-enrolment Form V12.0 (Jun 2017)
• PR08 Form 18: Saliva Pathology Form V14.0 (Jun 2018)
• PR08 Form 21: SOC Docetaxel Form V3.0 (Jun 2017)
• PR08 Form 22: Blood Form V4.0 (Jun 2018)
• PR08 Form 23: Tissue Sample Form V5.0 (Jun 2018)
• PR08 Form 24: Hormone Results Log (Patients Receiving Transdermal Oestradiol) V1.0 (Jun 2017)
• PR08 Form 25: Transdermal Oestradiol Treatment Log V1.0 (Jun 2017)
• PRO8 Form 01A: Stratified STAMPEDE Registration Form V1.0 (Nov 2017)
• PR08 Form 22: Stratified STAMPEDE Blood Form V5.0 (Jun 2018)
• Stratified STAMPEDE Sample Requisition Form V1.0
• Stratified STAMPEDE Test Request Form ALMAC V1.0

 

 

20-JUN-2017 to 04-JAN-2018

• Current CRF Versions v2.0
• Eligibility and Screening Checklist V2.0 (Jun 2017)
• PR08 Form 1: Randomisation Form V15.0 (Jun 2017)
• PR08 Form 2: Baseline Assessment Forms* V13.0 (Jun 2017)
• PR08 Form 7: Follow Up Form V14.0 (Jun 2017)
• PR08 Form 7: Follow Up Form without Toxicity Form V14.0 (Jun 2017)
• PR08 Form 7E: Toxicity Form V2.0 (Jun 2017)
• PR08 Form 7B: Hormone Therapy Log V3.0 (Jun 2017)
• PR08 Form 7C: Abiraterone and Enzalutamide Log V2.0 (Aug 2016)
• PR08 Form 7D: Metformin Log V1.0 (Aug 2016)
• PR08 Form 8: Progression Log V12.0 (Jun 2017)
• PR08 Form 8A: Additional Treatment Log V13.0 (Jun 2017)
• PR08 Form 9A: Radiotherapy Detail Form V13.0 (Jun 2017)
• PR08 Form 9B: Radiotherapy Acute Toxicity Form V12.0 (Jun 2017)
• PR08 Form 11: End of Research Treatment Form V12.0 (Jun 2017)
• PR08 Form 12: Death Form V12.0 (Jun 2017)
• PR08 Form 13: Quality of Life Form V10.0 (Jun 2017)
• PR08 Form 14: SAE Form V13.0 (Jun 2017)
• PR08 Form 15: Co-enrolment Form V12.0 (Jun 2017)
• PR08 Form 18: Saliva Pathology Form V13.0 (Jun 2017)
• PR08 Form 21: SOC Docetaxel Form V3.0 (Jun 2017)
• PR08 Form 22: Blood Form V3.0 (Jun 2017)
• PR08 Form 22: Stratified STAMPEDE Blood Form V4.0 (Oct 2017)
• PR08 Form 23: Tissue Sample Form V4.0 (Nov 2017)
• PR08 Form 24: Hormone Results Log (Patients Receiving Transdermal Oestradiol) V1.0 (Jun 2017)
• PR08 Form 25: Transdermal Oestradiol Log V1.0 (Jun 2017)
• Patient Transfer Form V2.0 (Nov 2014)

 

05-0SEP-2016 to 19-JUN-2017

• Current CRF Versions v1.0
• PR08 Form 1: Randomisation Form V14.0 (Aug 2016)
• PR08 Form 2: Baseline Assessment Form V12.0 (Aug 2016)
• PR08 Form 7: Follow Up Form V13.0 (Aug 2016)
• PR08 Form 7: Follow Up Form without Toxicity Form V13.0 (Aug 2016)
• PR08 Form 7E: Toxicity Form V1.0 (Aug 2016)
• PR08 Form 7B: SOC Hormone Therapy Log V2.0 (Aug 2016)
• PR08 Form 7C: Abiraterone and Enzalutamide Log V2.0 (Aug 2016)
• PR08 Form 7D: Metformin Log V1.0 (Aug 2016)
• PR08 Form 8: Progression Log V11.0 (Aug 2016)
• PR08 Form 8A: Additional Treatment Log V12.0 (Aug 2016)
• PR08 Form 9A: Radiotherapy Detail Form V12.0 (Aug 2016)
• PR08 Form 9B: Radiotherapy Acute Toxicity Form V11.0 (Aug 2016)
• PR08 Form 11: End of Research Treatment Form V11.0 (Aug 2016)
• PR08 Form 12: Death Form V11.0 (Aug 2016)
• PR08 Form 14: SAE Form V12.0 (Aug 2016)
• PR08 Form 15: Co-Enrolment Form V11.0 (Aug 2016)
• PR08 Form 21: SOC Docetaxel Form V2.0 (Aug 2016)
• Patient Transfer Form V2.0 (Nov 2014)

    

Prior to 05-SEP-2016

• PR08 Form 1: Randomisation form V13.0 (Dec 2015)
• PR08 Form 2: PR08 Form 1:Baseline form V11.0 (Jul 2014)
• PR08 Form 3: Cardiovascular assessment form V10.0 (Jul 2014)
• PR08 Form 4: Bisphosphonate treatment form, before 18 weeks (Arm B, E and F patients only) V10.0 (Jul 2014)
• PR08 Form 5: Bisphosphonate treament form, after 18 weeks (Arm B, E and F patients only) V10.0 (Jul 2014)
• PR08 Form 6: Docetaxel Treatment Form (Arm C and E patients only) V10.0 (Jul 2014)
• PR08 Form 7: Follow up form V12.0 (Jul 2014)
• PR08 Form 7A: Follow up form (post-progression) V11.0 (Jul 2014)
• PR08 Form 7B: Hormone therapy treatment form V1.0 (Jul 2014)
• PR08 Form 7C: Abiraterone and Enzalutamide Treatment Form (Arm G and J patients only) V1.0 (Jul 2014)
• PR08 Form 8: Progression & Additional Treatment Form V10.0 (Jul 2014)
• PR08 Form 8A: Additional Treatment Update Form V11.0 (Jul 2014)
• PR08 Form 9A: Radiotherapy Detail Form V11.0 (Jul 2014))
• PR08 Form 9B: Radiotherapy Acute Toxicity Form V10.0 (Jul 2014)
• PR08 Form 11: End of Treatment Form V10.0 (Jul 2014)
• PR08 Form 12: Death Form V10.0 (Jul 2014)
• PR08 Form 14: SAE form V11.0 (Dec 2015) 
• PR08 Form 15: Co-Enrolment Form V10.0 (Jul 2014)
• PR08 Form 16: Bone density risk factor questionnaire V10.0 (Jul 2014)
• PR08 Form 19: Palliative Radiotherapy Form V10.0 (Jul 2014)
• PR08 Form 21: SOC Docetaxel Treatment V1.0 (Dec 2015)
• Patient transfer form
• List of current CRFs used in STAMPEDE 2016 Feb
• List of current CRFs used in STAMPEDE 2015 Dec
• List of current CRFs used in STAMPEDE 2014 Oct
• List of current CRFs used in STAMPEDE 2014 Jul
• List of current CRFs used in STAMPEDE 2013 Jun
• List of current CRFs used in STAMPEDE 2013 Feb
• List of current CRFs used in STAMPEDE 2012 Aug

 

Superseded Sub Study Documents

Prior to 19-SEP-2017

• PR08 Form 11: Pathology Form V1.0 (Jun 2005)
• PR08 Form 13: Pathology Form V2.0 (Feb 2007)
• PR08 Form 18: Pathology Form V8.0 (Nov 2011)
• PR08 Form 18: Pathology Form V9.0 (Feb 2013)
• PR08 Form 18: Pathology Form V10.0 (Jul 2014)
• PR08 Form 18: Pathology Form V11.0 (Oct 2014)
• PR08 Form 18: Saliva Pathology Form V12.0 (Aug 2015)
• PR08 Form 22: Blood Form V1.0 (Jan 2016)
• PR08 Form 22: Blood Form V2.0 (Mar 2016)
• PR08 Form 23: Tissue Sample Form V1.0 (Jun 2016)
• PR08 Form 23: Tissue Sample Form V2.0 (Aug 2016)
• PR08 Form 23: Tissue Sample Form V3.0 (Jun 2017)