Investigator Site File

As the durvalumab and tremelimumab Investigator Brochures contain confidential information, they are kept within the Member's Area of the website. Please contact the RAMPART Team ( if you do not have the login details but require access to these documents.

  Current Version Previous Versions
TransRAMPART Bronze Sample Collection Manual v1.0 (23-Nov-2020)  
Drug Supply Management System User Guide v1.0 (31-May-2018)  


  Current Version Previous Version
All CRFs

Zip File All current CRFs

 ZIP Folder
CRF Completion Guidelines v7.0 (10-Mar-2023) v6.0 (28-Feb-2022),  v5.0 (28-Jun-2021)v4.0 (18-Feb-2021), v3.0 (03-Feb-2020)v2.0 (11-Apr-2019)v1.0 (10-Jul-2018)
Self-Evident Corrections Declaration v1.0 (31-May-2018)  
Eligibility & Screening Checklist v1.0 (25-Jun-2018)  
Randomisation CRF (Form 01) v7.0 (24-Feb-23) v6.0 (23-Mar-2022), v5.0 (28-May-2021), v4.0 (05-Feb-2021), v3.0 (01-Jul-2019)v2.0 (29-Mar-2019)v1.0 (25-Jun-2018)
Registration CRF (Form01A) v1.0 (23-Mar-2022)  
Eligibility Criteria CRF (Form 02) v4.0 (24-Feb-2023) V3.0 (28-May-2021), v2.0 (09-Feb-2021), v1.0 (25-Jun-2018)
Surgery CRF (Form 03) v3.0 (24-Feb-2023) v2.0 (29-Mar-2019), v1.0 (25-Jun-2018)
Concomitant Medications Log (Form 04) v1.0 (25-Jun-2018)  
Treatment CRF (Form 05A) v1.0 (24-Feb-2023) v3.0 (28-May-2021), v2.0 (29-Mar-2019), v1.0 (25-Jun-2018)
AE Log (Form 06) v1.0 (25-Jun-2018)  
End of Tremelimumab Treatment CRF (Form 07A) v1.0 (25-Jun-2018)  
End of Durvalumab Treatment CRF (Form 07B) v1.0 (25-Jun-2018)  
Post-Treatment CRF (Form 08) v2.0 (03-Feb-2020) v1.0 (25-Jun-2018)
Disease Assessment CRF (Form 09) v2.0 (05-Feb-2021) v1.0 (25-Jun-2018)
Progression CRF (Form 10) v4.0 (03-Feb-2020) v3.0 (not released), v2.0 (not released), v1.0 (25-Jun-2018)
PI Sign-off CRF (Form 11) v1.0 (03-Sep-2020)  
Death CRF (Form 12) v1.0 (25-Jun-2018)  
SAE CRF (Form 13) v3.0 (05-Feb-2021) v2.0 (03-Feb-2020)v1.0 (25-Jun-2018)
Pregnancy Monitoring CRF (Form 14) v1.0 (25-Jun-2018)  
EQ-5D Questionnaire (Form 15) v2.0 (09-Feb-2021) v1.0 (25-Jun-2018)
QLQ-C30 Questionnaire (Form 16) v2.0 (09-Feb-2021) v1.0 (25-Jun-2018)
Medical History CRF (Form 18) v1.0 (25-Jun-2018)  
Additional Lab CRF (Form 19A) v2.0 (31-May-2023) v3.0 (05-Feb-2021)v2.0 (03-May-2019)v1.0 (25-Jun-2018) v1.0 (24-Feb-2023)
New Primary Cancer CRF (Form 20) v1.0 (03-Feb-2020)  
Covid-19 CRF (Form 22) v1.0 (05-Feb-2021)  
PAIR Questionnaire (Form 23) v1.0 (25-Mar-2021)  
EDTA Blood Sample Collection Form v2.0 (30-Apr-2019) v1.0 (31-May-2018)
Archival Tissue Collection Form v1.0 (31-May-2018)  
  Current Version Previous Versions
Participant Information Sheet v8.0 (23-Jun-2023) v7.0 (17-Oct-2022), v5.0 (23-Mar-2021), v4.0 (26-May-2020), v3.0 (03-Dec-2019)v2.0 (18-Apr-2019)v1.0 (15-Dec-2017)
Participant Consent Form v2.0 (18-Apr-2019) v1.0 (03-Oct-2017)
GP Letter v1.0 (03-Oct-2017)  
Pregnant Partner Information Sheet v2.0 (18-Apr-2019) v1.0 (15-Dec-2017)
Pregnant Partner Consent Form v2.0 (18-Apr-2019) v1.0 (03-Oct-2017)
Patient Card (Arm A) v1.0 (18-Apr-2019)  
Patient Card (Arm B & C) v1.0 (18-Apr-2019)  
Pre-Surgery Factsheet v1.0 (16-Jul-2019)  
RAMPART End of Recruitment Lay Summary v2.0 (25-Jul-2023)  
  Current Version Previous Versions
UCL Insurance Statement 2023-24  2022-23 2021-22, 2020-21, 2019-202018-192017-18
  Current Version Previous Versions
Model Non-Commercial Agreement v3.0 (14-Aug-2018) v2.0 (09-Jul-2018)v1.0 (31-May-2018)
  Current Version Previous Versions
Training Slides v1.0 (31-May-2018)  
Training Log v1.0 (31-May-2018)  
Training Slides Protocol v6.0 RAMPART Protocol Amendment v6.0 training slides  
  Current Version Previous Versions
Delegation Log v2.0 (27-Sep-2018) v1.0 (31-May-2018)
Site Personnel List v1.0 (31-May-2018)  
Principal Investigator Statement v3.0 (30-Apr-2021) v2.0(28-Nov-2019), v1.0 (31-May-2018)
  Current Version Previous Versions
SAE Log v1.0 (14-Nov-2018)  
Annual Safety Reports  22-Jan-2023  22-Jan-2020 
  Current Version Previous Versions
Participant List v1.0 (21-Mar-2019)  
Screening Log v1.0 (31-May-2018)