INCH Radiotherapy QA Policy statement

Where staff of any speciality are contributing to INCH they may be asked to assist or participate in QA. Current postal, telephone, facsimile and email details for nominated staff in each centre will be held on a database for QA purposes. A website containing information relevant to the quality assurance process will be set up. This will contain QA protocols as well as information on the progress of the QA programme.

The QA will involve all staff groups.

Elements of QA identified as mandatory prior to randomisation will be accepted by participants.

Each centre will complete a short questionnaire focussed on trial patients (mandatory prior to randomisation) with sections on:

· Immobilisation and planning imaging

· Planning parameters (number of fields, arrangements and weighting, beam energies, collimation, wedges, inhomogeneity correction)

· Commissioning of the treatment planning system, including volume related calculations and heterogeneity corrections

· Treatment delivery facilities including backup, patient transfer facilities and image review

Prior to entering any patients in to the trial each centre will submit a patient plan (5 x transverse slices (optional coronal, sagittal views), beams eye views and dose-volume statistics for tumour and organs at risk). This will be a patient previously treated with radical radiotherapy at the centre who satisfies the eligibility criteria for INCH replanned according to the INCH protocol. Patients will not be randomised until this is submitted and accepted.

Each team (and there may be several teams) in a centre will complete a delineation exercise based on 3 example patient cases within 3 months of commencing randomisation. A planning exercise based on 1 example case with pre-delineated GTV, which may be an anthropomorphic dosimetry phantom, will be completed. These cases will be distributed and returned to the INCH Radiotherapy QA group, preferably electronically.

INCH Radiotherapy QA group members will carry out dosimetric and portal imaging QA using phantoms during one mandatory visit.

Ongoing QA will consist of mandatory notification for process change covering any of the items in the questionnaire including change or introduction of new medical staff.

Throughout the trial, a sample of patients will be requested from each centre by the INCH Radiotherapy QA group. Required details will include transverse slices x 5 (optional coronal, sagittal views), beams eye views and dose-volume statistics for tumour and organs at risk. The submission will take place either electronically or by hardcopy, dependent on facilities.

In the situation that the INCH Radiotherapy QA group identifies a non-conformity then revision of the local situation followed by further QA may be requested by the TMG.