Site File Trial Documentation
Investigator Site File
On this page you will find all relevant documents and resources for setting up and conducting the trial at your hospital and maintaining you Investigator Site File.
ISF Index
Please download the ISF index to make your own site file. This can be held electronically or you can print to have a paper version. Please note documents listed in italics are either not applicable or localised copies should be printed by the participating hospital.
Version LogLink opens in a new window
To help maintain version control, please download the version log which lists all previous and current versions of trial documentation.
Protocol Version LogLink opens in a new window
Section 1: Reference Information
1.1 Trial contacts and coordination team details
1.2 Trial Summary / Flow diagram
Section 2: Protocol
2.1 Current approved protocol
2.2 Previous approved versions of protocol
2.3 Version Log
2.4 Protocol deviation / non-compliance forms (these are held on the database, see file note)
Section 3: Information for participants
3.1 Current approved patient information sheet(s)
Brief Patient Information Sheet
Previous approved versions of patient information sheet(s)
3.2 Current approved patient consent form
Current approved Consultee declaration form
Previous approved versions of consent form(s)
3.3 Translations of Patient Information Sheet(s) and Consent Form(s)
Please email airways3@warwick.ac.uk to request patient facing documents in Bengali French Gujarati Polish Portuguese Punjabi Urdu
3.4 Version Log
3.5 Additional information for participants/Consultees
Cover Letter Patient Post Discharge
Cover Letter Consultee In-Hospital
Cover Letter Professional Consultee
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 documentation
4.2 HRA / REC approval of protocol amendments
Amendment documents can be found here
Section 5: CAG
5.2 CAG approval of protocol amendments
5.3 Reports of serious breaches
Section 6: Individual Site information and approvals
6.1 Principal Investigator CG and GCP (signed and dated)
6.3 Site agreement templateLink opens in a new window
6.4 Greenlight letter to commence recruitment
6.5 Other applications/approvals
6.6 Delegation and responsibilities signature log template
6.6 Site training log
6.7 SIV documents (visit the training page for documents)Link opens in a new window
Full SIV slides (if given)
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
8.3 Study aids and promotional materials - A4 poster
8.4 Newsletters
Section 9: Data Collection
9.1 AIRWAYS-3 Screening Log v4.0 01022024Link opens in a new window
9.2 Signed informed consent forms
9.3 Randomisation procedure
9.4 Source documents
9.5 Sample Case Report Forms (these are all hosted on the database or PWA)
Randomisation FormLink opens in a new window
9.6 Sample of patient questionnaires
Section 10: Safety Information
10.1 Serious Adverse Event related correspondence (these are held on the database, see file note)
10.2 Notification by sponsor to investigators of new safety information