Click below to download study amendment documents

Substantial amendment 1

Summary of Protocol changes in Amendment 1

IRAS Protocol amendment form

R&D Approval of the amendment

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

IRAS Protocol amendment form

REC covering letter for Protocol amendment

Confirmation of consideration of amendment by REC

Favourable REC opinion of amendment

Categorisation of amendment

HRA Confirmation of Amendment Assessment

R&D Approval of the amendment

Non Substantial Amendment 1 & HRA approval

HRA Approval Letter

HRA Confirmation Email

HRA Statement of Activities

HRA Schedule of Events

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

Statement of activities

Non Substantial Amendment 3

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 4

HRA Notification Letter

HRA Confirmation as Category B

HRA Statement of Activities

HRA Schedule of Events

HRA Covering Letter

Non Substantial Amendment 5

HRA Notification Letter

HRA Confirmation as Category B

HRA Statement of Activities

HRA Schedule of Events

HRA Covering Letter

Non Substantial Amendment 6

HRA Notification Letter

HRA Confirmation as Category B

HRA Statement of Activities

HRA Schedule of Events

HRA Covering Letter

Non Substantial Amendment 7

HRA Notification Letter

HRA Confirmation as Category B

HRA Statement of Activities

HRA Schedule of Events

HRA Covering Letter

Non Substantial Amendment 8

HRA Notification Letter

HRA Confirmation as Category B

HRA Statement of Activities

HRA Schedule of Events

HRA Covering Letter

Non Substantial Amendment 9

HRA Notification Letter

HRA Confirmation as Category B

HRA Statement of Activities

HRA Schedule of Events

HRA Covering Letter