In the SUPREMO trial, the quality assurance programme will allow us to confirm that participants have understood the technical guidelines within the protocol and implemented them correctly and that the dose prescription is delivered with appropriate documentation.

The QA programme we are using will build on that developed for the START trial, which has provided a basis for consensus among radiotherapy centres in the UK.

The QA programme includes:

• An initial questionnaire setting out precise details of the technique to be used, together with specimen patient outlines to be used to produce ideal plans.
  • Download QA instructions
  • Download questionnaire
  • UK centres who have not already completed a baseline questionnaire should also complete this
  • Centres should also complete a staff questionnaire
  • Download patient CT scan 1 (zipped file) 10MB extension relabelled as .zzz zipped file relabelled
  • Download patient CT scan 2 (zipped file) 16MB extension relabelled as .zzz zipped file relabelled (NB this patient file is labelled patient4)
  • Download manual outlines for patients 1 and 2 (zipped file) 3MB
  • Overview of QA patients including field lengths (powerpoint)
  • Download QA checklist
• A visit by the QA team, or a series of software tests (xls) to be performed on the planning system before a centre enters the study, this is to validate dosimetry in centres, which have not already had dosimetry independently verified for the equipment currently being used.
• Evidence of independent audit of all beams being used for treatment of patients within SUPREMO
• The QA team will collect the plans, together with verification images, for the first 5 patients in the treatment arm from each centre. 
• The QA team will then collect 1 in 10 plans to make sure the protocol is being followed.
• Approximately 1 in 10 patients will have TLD sent from the QA team for in vivo dosimetry (initially UK only). These patients will be identified at randomisation.
  For centres participating in the cardiac study centres should send copies of CT plans, or radiation port films together with treatment plans, should be sent for centralised documentation. We prefer these to be sent electronically.

The data from the quality assurance programme will be analysed separately from the main trial. You will be notified of any major discrepancies.