Summary of Changes
Patient documents have been updated.
Changes include:
- The trial IMP Label has been approved for Topotecan IMP.
- Patient ID cards have been created for distribution to sites.
- 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]