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
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
4. HRA
5. Regulatory
6. Individual Site Information
Eligibility criteria pocket cardsLink opens in a new window
**NEW** Eligibility ClarificationLink opens in a new window
FAQsLink opens in a new window
Landiolol infusion protocol compliance
Poster for clinical staff areas
Training for ICU clinical staff presentation
Training for non-GCP delegated clinical staff presentation
Refresher trainingLink opens in a new window
**NEW** Quick Guide to ConsentLink opens in a new window
7. Study Drugs
Summary of product characteristics
8. Laboratory
Aide memoir sample schedule information
Labels for plasma storage boxes
Trial lab manualLink opens in a new window
9. Monitoring
10. Data Collection
Template: Participant screening log (excel)Link opens in a new window
Template: Participant screening log (word)Link opens in a new window
Eligibility formLink opens in a new window
End of Trial Form and Sign-off statement
Randomisation formLink opens in a new window