Study Documents

Project 4.2 (OSIRIS Trial)

 

Study Protocols

• • OSIRIS Trial CIP v2

Patient Information

• • OSIRIS 4.2 Patient Information Sheet v2
  • OSIRIS 4.2 Patient Invitation Letter v2

Study Forms

• • OSIRIS 4.2 Patient Consent Form v2
  • OSIRIS MHRA Form

Study Logs

• • OSIRIS Trial Site Delegation Log v1

HRA Approvals

• • Letter of HRA Approval
  • HRA Favourable Opinion on Further Information (REC)
  • MHRA Final Outcome Letter
  • Schedule of Events

Standard Operating Procedures

• • Organisation Information Document – Intervention
  • Organisation Information Document – Standard Care
  • OSIRIS Decision Aid – Investigator’s Brochure
  • OSIRIS User Guide

Recommendations and Sponsorships

• • Notification Letter of Funding – OSIRIS
  • OSIRIS Device Sponsor CI Agreement – QM
  • QMUL Verification of Insurance

Site Agreement 

• • Site Agreement