PART B AMENDMENTS – In addition to the table below please complete NHS/R&D Substantial Amendment Approval /Implementation Log Noclor/Spon/T13/0X for all substantial amendments made subsequent to initial HRA approval of the study Classification (as confirmed by Details of Documents Bodies the Approval/Implementation sponsor) Submitted amendment has Date (substantial been notified to amendments) Version Number and Purpose (check all boxes Date (dd/mm/yyyy) Approval/ as appropriate) Acknowledgement Date Category Non (non-substantial Substantial/ Substantial New Revised clarifications) Description/ Clarification Day/Month/Year Amendment Amendment Code/Number Amendment A/B/C Brief of // REC // MHRA // HRA // Other (specify) REC // MHRA // HRA // Other (specify) //
PART B – AMENDMENTS In addition to the table below please complete NHS/R&D Substantial Amendment Approval /Implementation Log Noclor/Spon/T13/0X for all substantial amendments made subsequent to initial HRA approval of the study Amendment Code/Number Classification (as confirmed by sponsor) Brief Description/ Purpose of Amendment Amendment Category A/B/C Details of Documents Submitted Version Number and Date (dd/mm/yyyy) Bodies the amendment has been notified to (check all boxes as appropriate) Approval/Implementation Date (substantial amendments) Approval/ Acknowledgement Date (non-substantial clarifications) Day/Month/Year Substantial Non Substantial/ Clarification New Revised REC // MHRA // HRA // Other (specify) // REC // MHRA // HRA // Other (specify) //