ISF

1 Reference Information

2 Protocol v9.0 **NEW** 20-Mar-2023 & Statistical Analysis Plan

3 Information for Participants

4 HRA/REC

5 Individual Site Information

6 Blood Sampling

7 Training & Newsletters

8 Data Collection - New Screening Log & CRFs

10 Quick Reference

ISF
ISF Receipt v3.0

ISF Index v5.0_20-Apr-23

1.1 Trial Contact and Coordination Details v9.0

1.2 Trial Summary v3.0

2 Protocol

2.1 Protocol v9.0 **NEW** 20-Mar-2023

2.3 Protocol Version Control Log v9.0 **NEW** 20-Mar-2023

Statistical Analysis Plan_v1.1 (May 2022)

3 Information for Participants

3.1 Information Sheet/Consent Form - Commencement v7.0

3.1 Patient Information Sheet/Consent Form - Recovery v7.0

3.1 Information Sheet/Consent Form - Commencement - Scotland v7.0

3.1 Information/Consent Form - Recovery - Scotland v7.0

3.2 Information/Declaration Form - Consultee (incl Trust nominated) v7.0

3.2 Information Sheet - Guardian/Welfare Attorney Form - Scotland v7.0

3.4 Consultee / Guardian Information Sheet Version Control v7.0

3.4 Patient Information Sheet Version Control v6.0

3.5 ADAPT-Sepsis Patient Enrolment Labels

3.5 Eligibility Criteria Pocket Cards v2.0

3.6 GP Letter v5.0

3.7 Relatives Poster v1.0

4 HRA/REC

4.1 HRA REC Favourable Opinion 05 Sep 2017

4.1 Full REC Approval 20 Oct 2017

4.1 REC Committee Composition

4.1 Letter of HRA Approval 23 Oct 2017

4.2 HRA Assessment of Amendment Complete SA-01 15 Dec 2017

4.2 HRA Approval SA-01 11 Dec 2017

4.2 HRA Approval SA-02 27 Sep 2018
4.2 Confirmation of Favourable Opinion for Substantial Amendment SA-02 27 Sep 2018 / 11 Oct 2018

4.2 HRA Approval SA-03 27 Feb 2019 18 Apr 2019

4.2 Confirmation of Favourable Opinion REC_SA-05 05 Feb 2021

4.3 Annual Progress Report Oct 2018

4.3 Annual Progress Report October 2019

5 Individual Site Information

5.1 Site Selection Questionnaire v7.0

5.1 Trial Summary v3

5.5 Site Signature and Delegation Log v3.0

5.6 Site Visit Log v1.1

6 Blood Sampling

6.1 Blood Sample Stickers

6.2 A5 Blood Sample Request Form v2.0

7 Training & Newsletters

7.1 Investigator Training Log v1.0

7.1 Site Initiation Visit Attendance Log v1.0

7.2 Co-enrolment

7.3 Newsletters

8 Data Collection

8.1 Screening Log v5.0 (pdf)

8.1 Screening Log v5.1 (excel)

8.5 CRFs *NEW*

10 Quick Reference

10.1 CRF Completion Guidelines v1.1

10.2 Clinical Team Emergency Sampling Back-Up Flow Charts v1.1

10.2 Lab Emergency Sampling Back-Up Flow Charts v1.0