Skip to main content Skip to navigation

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.Link opens in a new window
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: stress-l@warwick.ac.uk 

2 **NEW** Infographic tools are now available to assist with eligibility clarificationLink opens in a new window and consent Link opens in a new windowpost 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 SummaryLink opens in a new window

2. Protocol

Current approved protocol

Protocol version logLink opens in a new window

3. Information for Participants

Legal Representative Information Sheet

Patient Information SheetLink opens in a new window

Short Patient Information SheetLink opens in a new window

Consent formLink opens in a new window

Legal representative consent formLink opens in a new window

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 cardsLink opens in a new window

**NEW** Eligibility ClarificationLink opens in a new window

Enrolment labels

Current evidence

FAQsLink opens in a new window

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 trainingLink opens in a new window

Trial Certificate

Newsletters

**NEW** Quick Guide to ConsentLink opens in a new window
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 manualLink opens in a new window

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)Link opens in a new window 

Template: Participant screening log (word)Link opens in a new window

CRF booklet

Eligibility formLink opens in a new window

End of Trial Form and Sign-off statement

Randomisation formLink opens in a new window

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