Substantial Amendment 14

 

  • REC Letter- AM14, 07-Sep-2018 [.pdf]
  • MHRA Approval Letter AM14, 18-Sep-2018 [.pdf]
  • HRA Approval Email AM14, 10-Oct-2018 [.pdf]
  • Notification of Substantial Amendment (CTIMP) AM14, 13-Jul-2018 [.pdf]
  • CompARE REC Cover Letter AM14, 14-Aug-2018 [.pdf]
  • Investigator Site File Checklist v19.0, 16-Oct-2018 [.pdf]
  • (Patient) Trial Summary Sheet v7.0, 11-Jul-2018 [.pdf]
  • GP Letter v4.0, 11-Jul-2018 [.pdf]
  • Release of Medical Information, v3.0, 11-Jul-2018 [.pdf]
  • Informed Consent Form A, v5.0, 14-Jun-2018 [.pdf]
  • Informed Consent Form B, v6.0, 14-Jun-2018 [.pdf]
  • Informed Consent Form C, v3.0, 14-Jun-2018 [.pdf]
  • Informed Consent Form CompARE Collect, v5.0, 14-Jun-2018 [.pdf]
  • Patient Information Sheet A, v5.0, 11-Jul-2018 [.pdf]
  • Patient Information Sheet B, v5.0, 11-Jul-2018 [.pdf]
  • Patient Information Sheet C, v3.0, 11-Jul-2018 [.pdf]
  • Patient Information Sheet D, v3.0, 11-Jul-2018 [.pdf]
  • Patient ID Cards, v2.0, 14-Jun-2018 [.pdf]
  • Patient Arm 5 Cards, v1.0, 11-Jul-2018 [.pdf]
  • Protocol v6.0, 13-Jul-2018 [.pdf]
  • Trial Synopsis v7.0, 13-Jul-2018 [.pdf]
  • Pharmacy Manual, v6.0, 29-Aug-2018 [.pdf]
  • Eligibility Checklist, v6.0, 31-Aug-2018 [.pdf]