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Investigator Site File Documentation

On this page you will find all relevant documents and resources for setting up and conducting the trial at site.
To help you with this, please find a version control log listing all of our documents here.
If you wish to print these documents to create a paper ISF, please find an index here. An ISF receipt can be found here.

To request previous document versions please email: 

2 **NEW** Infographic tools are now available to assist with eligibility clarification and consent post COVID.

1. Reference Information
2. Protocol
3. Information for Participants
4. HRA
5. Regulatory
6. Individual Site Information and Approvals
7. Study Drugs
8. Laboratory
9. Monitoring
10. Data Collection
11. Safety Information
12. Trial Specific Working Instructions
1. Reference Information

Trial contacts and coordination details

Trial Summary

2. Protocol

Current approved protocol

Protocol version log

3. Information for Participants

Legal Representative Information Sheet

Patient Information Sheet

Short Patient Information Sheet

Consent form

Legal representative consent form

Note to file version log

GP letter

4. HRA

Initial REC approval

Initial HRA approval

REC committee composition

Substantial Amendments

Substantial amendments log

5. Regulatory

Initial MHRA approval

Substantial Amendments

Substantial amendments log

6. Individual Site Information

Feasibility questionnaire

Delegation log

Investigator training log

Eligibility criteria pocket cards

**NEW** Eligibility Clarification

Enrolment labels

Current evidence


Landiolol infusion protocol compliance

Poster for clinical staff areas

Poster for landiolol infusion

Relatives poster

SIV presentation

Training for ICU clinical staff presentation

Training for non-GCP delegated clinical staff presentation

Refresher training

Trial Certificate


**NEW** Quick Guide to Consent
7. Study Drugs

Summary of product characteristics

IMP Label 2-8 degree

Landiolol Dosing Laminate

Noradrenaline Dosing Laminate

IMP Management Manual

ICU IMP Inventory Log

ICU IMP destruction log

8. Laboratory

Aide memoir sample schedule information

Drug line usage

Labels for plasma storage boxes

Labels for Biobank samples

Labels for research samples

Pharmacy prescription labels

Trial lab manual

Syringe label

Sample storage form

Sample transport form

9. Monitoring

Site visit log

10. Data Collection

Enrolment log

NTF screening data

Template: Participant screening log (excel) 

Template: Participant screening log (word)

CRF booklet

Eligibility form

End of Trial Form and Sign-off statement

Randomisation form

CRF Completion Guidelines

CTCAE quick reference

11. Safety Information

Initial SAE form

Follow-up SAE form

SAE continuation form

12. Trial Specific Working Instructions

Data Transfer Working Instructions

Trial Participant Completion Checklist