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Trial 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 hereLink opens in a new window.

Investigator Site File Contents:

Reference Information

eISF Receipt Link opens in a new window

Trial Contacts and Coordination DetailsLink opens in a new window

iRehab Trial SummaryLink opens in a new window

Protocol

ProtocolLink opens in a new window

Information for Participants

Participant Information sheetLink opens in a new window

Consent Form Link opens in a new window

Patient Invitation Poster

Consultant Letter Link opens in a new window

GP Letter Link opens in a new window

Patient Invitation Letter Link opens in a new window

Main Ethics

HRA Approval Link opens in a new window

REC Approval Link opens in a new window

IRAS ApplicationLink opens in a new window

Amendments
  • Substantial Amendment 1

HRA ApprovalLink opens in a new window

REC ApprovalLink opens in a new window

Summary of changes:

Amendment to project timelines due to longer set-up time. Addition of written instructions for participants. Edits to SoECAT to make this site-specific. Minor edits to documents such as questionnaires, PILs, protocol and cover letter for smart watch. Inclusion of trial website screenshots for review. Inclusion of questionnaires for the Process Evaluation.

Site Information and Approvals

Feasibility QuestionnaireLink opens in a new window

Delegation Log Link opens in a new window

Site Training SlidesLink opens in a new window

Site Training Attendance Log Link opens in a new window

Database TrainingLink opens in a new window

General Site Information

Investigator Training Log Link opens in a new window

CRF Completion Guidelines Link opens in a new window

Data Collection

Pre Screening Log Link opens in a new window

1. Screening Form Link opens in a new window

2. Contact Details Form Link opens in a new window

3. Registration Consent Form (Watermarked) Link opens in a new window

4. Co-morbidities Form (Watermarked) Link opens in a new window

5. Readmission Form (Watermarked) Link opens in a new window

6. Protocol Deviation Form (Watermarked) Link opens in a new window

7. File Note (Watermarked) Link opens in a new window

8. Adverse Event Form Link opens in a new window

9. Initial Serious Adverse Event Form Link opens in a new window

10. Serious Adverse Event Continuation Form Link opens in a new window

11. Follow-Up Serious Adverse Event Form Link opens in a new window

12. Discontinued Treatment Form (Watermarked) Link opens in a new window

13. Withdrawal Form (Watermarked) Link opens in a new window

14. Notification of Death Form (Watermarked) Link opens in a new window

Serious Adverse Event Evaluation Form Link opens in a new window