Substantial Amendment SA21

Summary of Changes

Patient documents have been updated.

An addendum to the current and previous Parent and Patient Information Sheets has been created to enable the patient to re-consent for the collection of follow up data for at least 5 years after treatment, rather than for up to 5 years after treatment. This is in line with the current protocol v7.0 dated 07Feb2020.

  • Amendment Tool [pdf 309KB]
  • REC Cover letter (SA21) [pdf 729KB]
  • REC Approval (SA21) [pdf 155KB]
  • HRA approval (SA21) [pdf 264KB]