Investigator Site File

  Current Version Previous Versions
RAMPART Protocol v3.0 (28-Nov-2019) v2.0 (18-Apr-2019)v1.0 (22-Nov-2019)

 

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 (mrcctu.rampart@ucl.ac.uk) if you do not have the login details but require access to these documents.

  Current Version Previous Versions
Sample Collection Manual v2.0 (20-May-2019) v1.0 (31-May-2018)
Drug Supply Management System User Guide v1.0 (31-May-2018)  

 

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All CRFs

ZIP Folder

 
CRF Completion Guidelines 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) v3.0 (01-Jul-2019) v2.0 (29-Mar-2019)v1.0 (25-Jun-2018)
Eligibility Criteria CRF (Form 02) v1.0 (25-Jun-2018)  
Surgery CRF (Form 03) v2.0 (29-Mar-2019) v1.0 (25-Jun-2018)
Concomitant Medications Log (Form 04) v1.0 (25-Jun-2018)  
Treatment CRF (Form 05) 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) 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) 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) v1.0 (25-Jun-2018)  
QLQ-C30 Questionnaire (Form 16) v1.0 (25-Jun-2018)  
Medical History CRF (Form 18) v1.0 (25-Jun-2018)  
Additional Lab CRF (Form 19) v2.0 (03-May-2019) v1.0 (25-Jun-2018)
New Primary Cancer CRF (Form 20) v1.0 (03-Feb-2020)  
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 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)  
  Current Version Previous Versions
UCL Insurance Statement 2019-20 2018-192017-18
  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)  
  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 v1.0 (31-May-2018)  
  Current Version Previous Versions
ISF Self-Assessment Checklist v4.0 (28-Jan-2020) v3.0 (31-May-2019)v2.0 (29-Mar-2019)v1.0 (31-May-2018)
Site Activation Checklist v1.0 (31-May-2018)  
  Current Version Previous Versions
SAE Log  v1.0 (14-Nov-2018)  
Annual Safety Reports 22-Jan-2020  
  Current Version Previous Versions
Participant List v1.0 (21-Mar-2019)  
Screening Log v1.0 (31-May-2018)