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Site File Trial Documentation

On this page you will find all relevant documents and resources for setting up and conducting the trial at your ambulance service.
ISF indexLink opens in a new window

Please download the ISF index to make your own site file and print the documents listed below. Please note documents listed in italics are either not applicable or localised copies should be printed by the participating ambulance service.

Version Log V2.0 08Nov2023

Previous Version Log V1.0 15Sep2021

To help maintain version control, please download the version log which lists all previous and current versions of trial documentation.

Section 1: Reference Information

1.1 Trial Reference and Contact Details

1.2 Trial Summary / Flow diagramLink opens in a new window

Section 2: Protocol

2.1 Current approved protocol

Protocol, v4.0, 10 August 2023

2.2 Previous approved versions of protocol

Protocol, v2.0, 23 June 2021Link opens in a new window

Protocol, v3.0, 23 November 2021

Protocol, v3.1, 13 February 2023

2.3 Version Log

2.4 Protocol deviation / non-compliance forms

Section 3: Information for participants

3.1 Current approved patient information sheet, v3.0, 10 August 2023

Easy read patient information sheet, v1.0, 10 August 2023

Previous approved versions of patient information sheet(s)

Patient Information Sheet, v2.1, 14 July 2021

3.2 Current approved patient consent formLink opens in a new window

Current approved Consultee declaration formLink opens in a new window

Previous approved versions of consent form(s)

3.3 Translations of Patient Information Sheet(s) and Consent Form(s)Link opens in a new window

3.4 Version Log

3.5 Cover Letter Consultee In-hospitalLink opens in a new window

3.5 Cover Letter Patient Post dischargeLink opens in a new window

3.5 Questionnaire cover letterLink opens in a new window

Section 4: Main ethics

4.1 HRA approval for protocol and supporting documentationLink opens in a new window

4.1 REC approval for protocol and supporting documentationLink opens in a new window

4.1 IRAS formLink opens in a new window

4.2 HRA / REC approval of protocol amendments

Substantial Amendment 01 relevant documents

SA01 Amendment Tool

SA01 HRA favourable Opinion

SA01 REC favourable opinion

Substantial Amendment 02 relevant documents

SA02 Amendment Tool

SA02 HRA favourable opinion

SA02 REC favourable opinion

Non Substantial Amendments:

NSA01 not relevant to all sites

NSA02 not relevant to all sites

NSA03 protocol update

NSA03 Amendment Tool

NSA03 REC amendment message

NSA04 not relevant to all sites

NSA05 extension to recruitment timelines

NSA05 Amendment Tool

NSA05 amendment message

NSA06 not relevant to all sites

Section 5: CAG

5.1 CAG approval letterLink opens in a new window

5.2 CAG approval of protocol amendments

SA02 CAG email

SA02 confirmation approval not required

5.3 Reports of serious breaches

Section 6: Individual Site information and approvals

6.1 Principal Investigator CG and GCP (signed and dated)

6.2 SoECATLink opens in a new window

6.2 OID (ambulances)Link opens in a new window

6.3 Site agreement template v2.2 Jan 2021Link opens in a new window

Site agreement template v2.3 Jul 2022

6.4 Greenlight letter to commence recruitment

6.5 SoE (hospitals)Link opens in a new window

6.5 OID (hospitals)Link opens in a new window

6.6 Delegation and responsibilities signature log templateLink opens in a new window

6.6 Site training logLink opens in a new window

6.7 SIV documents. Trial initiation monitoring report/letter

6.8 Relevant communications (e.g. letters, meeting notes, notes of telephone calls)

Section 7: Monitoring

7.1 Monitoring visit reports/letters/checklists

7.2 Final Trial Close-Out Monitoring Report/letters

Section 8: General site information

8.1 List of Investigators & updates

8.2 Study specific training documentation - SIV slides for ambulance service research team

SIV slides v2.2

8.3 Study aids and promotional materials - A4 posterLink opens in a new window

8.4 Newsletters

Section 9: Data Collection

9.1 Screening log templateLink opens in a new window

9.2 Signed informed consent forms

9.3 Randomisation confirmation reports/emails

9.4 Sample Case Report Forms (CRFs)

CRF Booklet

Initial SAE Form v1.0 12 August 2021

SAE Evaluation form v1.0, 12 August 2021

SAE Follow-Up form v1.0, 12 August 2021

9.5 Sample of patient questionnaires - 3 monthsLink opens in a new window and 6 monthsLink opens in a new window

9.6 Approved list of fields where self-evident corrections are to be allowed

9.7 Randomisation Accountability log templateLink opens in a new window

9.8 Randomisation Envelope destruction logLink opens in a new window

Section 10: Safety Information

10.1 Serious Adverse Event related correspondence

10.2 Notification by sponsor to investigators of new safety information

Section 11: Trial Specific Working Instructions

11.1 Randomisation template SOPLink opens in a new window

11.1 CRF guidance document

National Data Opt Out Guidance

National Data Opt-Out Guidance v1.0 08 November 2023,

National Data Opt Out CRF with notes v1.0 08 November 2023