PHAZAR Amendments

Summary of Amendments [.pdf]

Above is a link to a document which lists all of the substantial protocol amendments which have been made for this trial.

The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

Substantial Amendment 6

  • Cover letter - REC [.pdf]
  • Cover letter - MHRA [.pdf]
  • Notice of Substantial Amendment SA06 [.pdf]
  • REC approval [.pdf]
  • MHRA approval [.pdf]
  • HRA Categorisation [.pdf]
  • HRA approval [.pdf]
  • Protocol v5.0 - tracked [.pdf]
  • Protocol v5.0 - clean [.pdf]
  • Summary of protocol changes [.pdf]
  • PIS - Interventional v6.0 - tracked [.pdf]
  • PIS - Interventional v6.0 - clean [.pdf]
  • Patient Cards v2.0 - tracked [.pdf]
  • Patient Cards v2.0 - clean [.pdf]

Substantial Amendment 5

  • Cover letter - MHRA [.pdf]
  • Notice of Substantial Amendment SA05  [.pdf]
  • MHRA Approval [.pdf]

Substantial Amendment 4

  • Cover letter - REC [.pdf]
  • Notice of Substantial Amendment SA04 [.pdf]
  • Amendment categorisation [.pdf]
  • REC approval [.pdf]
  • HRA approval [.pdf]

Substantial Amendment 3

  • REC cover letter for SA03 [.pdf]
  • MHRA cover letter for SA03 [.pdf]
  • Notice of Substantial Amendment SA03 (Annex 2) [.pdf]
  • REC Confirmation of new PIs at existing sites 31-Oct-2016 [.pdf]
  • REC Approval for SA03 18-Nov-2016 [.pdf]
  • MHRA Approval for SA03 24-Nov-2016 [.pdf]
  • HRA Approval for SA03 05-Dec-2016 [.pdf]

Substantial Amendment 2

  • Substantial Amendment 2.0  [.zip]
    • REC Cover letter [.pdf]
    • MHRA Cover letter [.pdf]
    • Notice of Substantial Amendement SA02 [.pdf]
    • REC approval letter [.pdf]
    • MHRA approval letter [.pdf]

 

Substantial Amendment 1

  • Substantial Amendment 1.0  [.zip]
    • REC Cover letter [.pdf]
    • Notice of Substantial Amendment SA01 [.pdf]
    • REC approval letter [.pdf]

Non-Substantial Amendments

  • Non-substantial Amendment 3.0
    • Cover letter [.pdf]
    • HRA Categorisation [.pdf]
    • HRA Approval [.pdf]

  • Non-substantial Amendment 2.0  [.zip]
    • ICF - Observational v3.0a - tracked [.pdf]
    • PIS Obserational v3.0a - tracked [.pdf]
    • Note to file - v3.0a Patient Documents [.pdf]

  • Non-substantial Amendment 1.0  [.zip]
    • Consent Form - Donating Tissue Research v1.0a [.pdf]
    • PIS - Observational v1.0a [.pdf]
    • Note to file - v1.0a Patient Documents [.pdf]