Click below to download study amendment documents

Non Substantial Amendment 1

Confirmation of Amendment Categorisation as Category B

Non-substantial amendment notification

Minor amendment covering letter

HRA schedule event spreadsheet

Statement of activities

Non Substantial Amendment 2

Confirmation of Amendment Categorisation as Category B

Non-substantial amendment notification

Minor amendment covering letter

HRA schedule event spreadsheet

Statement of activities

Non Substantial Amendment 3

Confirmation of Amendment Categorisation as Category B

Non-substantial amendment notification

Minor amendment covering letter

Summary of changes to the Patient Information Sheet

Non Substantial Amendment 4

Amendment Acknowledgement and Implementation Information

Non-substantial amendment notification

Minor amendment covering letter

HRA schedule event spreadsheet

Statement of activities

Non Substantial Amendment 5

QMUL Acknowledgement

Confirmation of Amendment Categorisation as Category B

Amendment notification

Minor amendment covering letter

Non Substantial Amendment 6

Amendment Acknowledgement and Implementation Information

Non-substantial amendment notification

Minor amendment covering letter

HRA schedule event spreadsheet

Statement of activities

Non Substantial Amendment 7 (only applicable to University College Hospital)

Amendment Acknowledgement and Implementation Information

Non-substantial amendment notification

Minor amendment covering letter

HRA schedule event spreadsheet

Statement of activities

Non Substantial Amendment 8 (only applicable to Chelsea and Westminster Hospital NHS Foundation Trust)

Amendment Acknowledgement and Implementation Information

Non-substantial amendment notification

Non Substantial Amendment 9

Acknowledgement of Trial Suspension

Non-substantial amendment notification

Non Substantial Amendment 10

Acknowledgement of Trial Restart

Non-substantial amendment notification

Non Substantial Amendment 11

Amendment Acknowledgement and Implementation Information

Non-substantial amendment notification

Amendment tool