Investigator Site File

Protocol

	Current Version	Previous Versions
RAMPART Protocol	v6.0 (22_Aug-22)	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)

Investigator Brochures

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	Zip File All current CRFs	ZIP Folder
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)	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	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)

	Current Version	Previous Versions
UCL Insurance Statement	2021-22	2020-21, 2019-20, 2018-19, 2017-18

	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
ISF Self-Assessment Checklist	v8.0 (10-Feb-2023)	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-2023	22-Jan-2020

	Current Version	Previous Versions
Participant List	v1.0 (21-Mar-2019)
Screening Log	v1.0 (31-May-2018)