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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 IndexLink opens in a new window

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.

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

V1.1 09/05/2022

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)

Patient Information Sheet

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)

3.4 Version Log

3.5 Additional information for participants/Consultees

Relative Sheet

Cover Letter Patient Post Discharge

Cover Letter Consultee In-Hospital

Cover Letter Professional Consultee

Questionnaire Cover Letter

Section 4: Main ethics

4.1 HRA approval for protocol and supporting documentation

4.1 REC approval for protocol and supporting documentation

4.1 IRAS form

4.2 HRA / REC approval of protocol amendments

Section 5: CAG

5.1 CAG approval letter

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)

6.2 SoECAT

6.2 OID

6.3 Site agreement template

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

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 Screening log template

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 Form

Post Randomisation form

CRF Booklet

9.6 Sample of patient questionnaires

3 Month Questionnaire

6 Month Questionnaire

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

Section 11: Trial Specific Working Instructions