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SA-03

Summary of Changes

Protocol amended, v2.0 vd24-Nov-2017 (not issued). Details of Sorafenib dosing schedule (Table 14) and administration (section 9.2.6) added following urgent safety measure. Protocol issued after Non substantial amendment A-06 to Protocol v2.0a vd 17-Jan-2018

SA-03 Notification of a Substantial Amendment [pdf]
SA-03 IRAS 212527 HRA Approval and Categorisation [pdf]
SA-03 REC Cover letter 06-Dec-2017 [pdf
SA-03 REC Favoriable opinion [pdf]
SA-03 MHRA Cover letter 06-Dec-2017 [pdf]
SA-03 MHRA Notice of Acceptance of Amendment 12-Jan-2018 [pdf]