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.
Previous 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
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
Protocol, v4.0, 10 August 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
3.5 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
Substantial Amendment 02 relevant documents
SA03 Superseded by SA04
SA04 REC and HRA favourable opinion
Non Substantial Amendments:
NSA01 not relevant to all sites
NSA02 not relevant to all sites
NSA03 protocol update
NSA04 not relevant to all sites
NSA05 extension to recruitment timelines
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
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)
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