SA06

Summary of Changes

Patient documents have been updated.

Changes include:

  1. The trial IMP Label has been approved for Topotecan IMP.
  2. Patient ID cards have been created for distribution to sites.
  3. Patient Information Sheet and Parent Information Sheet have been amended to clarify the expected labelling and identification of samples and data used for research in the trial.
  • SA-06 Notification of a Substantial Amendment [pdf]
  • SA-06 MHRA Approval [.pdf]
  • SA-06 MHRA Cover letter [.pdf]
  • SA-06 REC Approval  [pdf]
  • SA-06 REC Cover letter  [pdf]