STOMP: Amendment 1, 01-Mar-2016

Substantial Amendment 1.0

  • REC letter of favourable opinion SA1 [.pdf]
  • Annexe 2 Form Section F - Description of Each Substantial Amendment [.pdf]
  • Investigators Brochure AZD2281 Edition 8 [.pdf]
  • Amendment 1 Cover Letter 15-Apr-2013 [.pdf]
  • GP Letter V3.0 13-Mar-2013 Tracked Clean [.pdf]
  • ICF Version 2.0 12-Sep-Final  [.pdf]
  • Label Proof Signed [.pdf]
  • Notification of Substantial Amendment Form Signed [.pdf]
  • Patient Card Version 2.0 12-Sep-2012 [.pdf]
  • Patient Diary BD version 2.0 13-Mar-2013 [.pdf]
  • Patient Diary TDS version 1.0 13-Mar-2013 [.pdf]
  • PIS V3.0 13-Mar-2013 Tracked Clean [.pdf]
  • Trial Summary v2.0 13-Mar-2013 tracked Clean [.pdf]