All centers wishing to enter patients in studies where Radiotherapy is part of protocol treatment, are subject to meeting the minimum site requirements for accreditation purposes. These requirements are indicative in nature and may be subject to considerable variations depending on the complexity of treatment planning, the proportion of patients entered in research trials, the academic commitment (including the number of radiation oncologists in training), the number of multidisciplinary meetings and the general involvement in research and development of the institution. Departments or hospitals must also fulfill the general requirements of EORTC membership.
All centers participating in trials of the EORTC Radiation Oncology Group and joint studies with other EORTC Groups must provide information on their radiotherapy treatment infrastructure. This information must be kept updated at least every 2 years or earlier if there is significant change in personnel or equipment. EORTC accredited radiation oncology departments (those contributing actively to the clinical studies of the Radiation Oncology Group) can be university divisions, departments in a public hospital or cancer center, or a private practice unit provided it has a formal collaboration with a state-recognized hospital.
It is required that submission of data for accreditation of the radiation oncology department is handled through a responsible person of the department itself.
Human resources and workload:
The minimum number of full-time equivalent (FTE) radiation oncologists in an EORTC radiation oncology department should be 3.
The maximum number of patients treated per year per full-time radiation oncologist is 250 (with an absolute maximum of 300).
The EORTC accredited radiation oncology department must have at least 1.3 FTE qualified radiation physicists that are responsible for checking all radiation physics parameters and dosimetry within the department. The mean workload per qualified radiation physicist should not exceed 500 patients per year; this number can be higher in the case of adequate support from additional staff such as dosimetrists, clinical engineers, etc. which should be made clear in the submission.
The minimum number of radiation technologists present during treatment administration, per treatment unit, must be 2.
Additional staff should be available as necessary for other activities including treatment preparation.
Equipment and workload
The center must meet the following equipment requirements:
at least two megavoltage treatment units that enable daily radiotherapy treatments (according to the protocol) during maintenance and unscheduled downtime of a treatment machine. The two treatment units are preferably less than 10 years old (maximum 15 years old). These units must be equipped with portal imaging and multileaf collimation (or equivalent).
At least one simulator (classical or virtual CT-simulator) or access to CT scanning and optionally other imaging equipment, depending on the protocol.A 3D treatment planning system.
The overall workload of patients per year should not exceed 1200 per conventional simulator and 2400 per CT simulator based on normal working hours. The maximum workload of patients per year/per megavoltage unit is 600 based on normal working hours.
NOTE: Units with a Cobalt source may not be used to treat trial patients.
An institutional Quality Assurance Program is mandatory. This should comprise of periodic checks of treatment equipment (beam calibration, output checks) and treatment related processes (patient chart review, in vivo dosimetry). Details of the program must be provided.