Click below to download study amendment documents
Substantial amendment 1
Summary of Protocol changes in Amendment 1
REC covering letter for Protocol amendment
Confirmation of consideration of amendment by REC
Favourable REC opinion of amendment
HRA Confirmation of Amendment Assessment
Substantial amendment 2
Summary of Protocol changes in Amendment 2
REC covering letter for Protocol amendment
Confirmation of consideration of amendment by REC
Favourable REC opinion of amendment
HRA Confirmation of Amendment Assessment
Non Substantial Amendment 1 & HRA approval
HRA Covering Letter for Minor Amendment 1
Non Substantial Amendment 2
Confirmation of Amendment Categorisation as Category B
Non-substantial amendment notification
Minor amendment covering letter
HRA schedule event spreadsheet
Non Substantial Amendment 3
Confirmation of Amendment Categorisation as Category B
Non-substantial amendment notification
Minor amendment covering letter
HRA schedule event spreadsheet
Non Substantial Amendment 4
HRA Confirmation as Category B
Non Substantial Amendment 5
HRA Confirmation as Category B
Non Substantial Amendment 6
HRA Confirmation as Category B
Non Substantial Amendment 7
HRA Confirmation as Category B
Non Substantial Amendment 8
HRA Confirmation as Category B
Non Substantial Amendment 9
HRA Confirmation as Category B
Non Substantial Amendment 10
HRA Confirmation as Category B
Non Substantial Amendment 11
HRA Confirmation as Category B