Investigator Site File
Current Version | Previous Versions | |
RAMPART Protocol | v5.0 (23-Mar-2021) | v4.0 (26-May-2020), 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 | |
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 | ||
CRF Completion Guidelines | 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) | 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) | v3.0 (28-May-2021) | v2.0 (09-Feb-2021), 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) | 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 19) | v3.0 (05-Feb-2021) | v2.0 (03-May-2019), v1.0 (25-Jun-2018) |
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 | 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) |
Original Application | Protocol Amendment (v2.0) | Protocol Amendment (v3.0) | Protocol Amendment (v4.0) |
Notification of Substantial Amendment Form
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Notification of Substantial Amendment Form
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Protocol Amendment (v5.0) | |||
Original Application | Protocol Amendment (v2.0) | Protocol Amendment (v3.0) | Protocol Amendment (v4.0) |
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Protocol Amendment (v5.0) | |||
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Original Application | Protocol Amendment (v2.0) | Protocol Amendment (v3.0) | Protocol Amendment (v4.0) |
Notification of Substantial Amendment
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REC Cover Letter |
Protocol Amendment (v5.0) | |||
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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 | v3.0 (30-Apr-2021) | v2.0(28-Nov-2019), v1.0 (31-May-2018) |
Current Version | Previous Versions | |
ISF Self-Assessment Checklist | v7.0 (28-Jun-2021) | v6.0 (21-May-2021), v5.0 (03-Jul-2020), 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) |