Site File Documentation
2 Protocol v9.0 20-Mar-2023 & Statistical Analysis Plan
3 Information for Participants
8 Data Collection - New Screening Log & CRFs
1.1 Trial Contact and Coordination Details v9.0
2.3 Protocol Version Control Log v9.0 20-Mar-2023
Statistical Analysis Plan v1.1 (May 2022)
Statistical Analysis Plan v2.0 (March 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 Version Control Log
4.1 HRA REC Favourable Opinion 05 Sep 2017
4.1 Full REC Approval 20 Oct 2017
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 HRA Approval SA-03 27 Feb 2019
4.2 HRA Approval SA-04 25 Nov 21
4.2 HRA Approval SA-05 25 Nov 21
4.2 HRA Approval SA-06 25 Nov 21
4.2 HRA Approval NSA-10 Nov 20
4.2 HRA Approval NSA-12 Oct 21
4.2 HRA Approval NSA-14 Nov 21
4.2 HRA Approval NSA-15 Jan 22
4.2 HRA Approval NSA-17 Feb 22
4.2 HRA Approval NSA-19 May 22
4.2 HRA Approval NSA-21 Aug 22
4.2 HRA Approval NSA-22 Oct 22
4.2 HRA Approval NSA-23 Mar 23
4.2 HRA Approval NSA-26 Nov 24
4.3 Annual Progress Report Oct 2018
4.3 Annual Progress Report October 2019
5.1 Site Selection Questionnaire v7.0
5.5 Site Signature and Delegation Log v3.0
6.2 A5 Blood Sample Request Form v2.0
7.1 Investigator Training Log v1.0
7.1 Site Initiation Visit Attendance Log v1.0
7.2 Co-enrolment
8.1 Screening Log v5.1 (excel)
10.1 CRF Completion Guidelines v1.1
10.2 Clinical Team Emergency Sampling Back-Up Flow Charts v1.1