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 | 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) | 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) |
| 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) |
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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) |
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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) |