Quality assurance EORTC Radiation Oncology Group quality assurance platform: Establishment of a digital central review facility Alysa Fairchild a,b,⇑ , Edwin Aird c , Paul A. Fenton d , Vincent Gregoire e , Akos Gulyban f , Denis Lacombe a , Oscar Matzinger g , Philip Poortmans h , Pascal Ruyskart a , Damien C. Weber i , Coen W. Hurkmans j a EORTC Headquarters, Brussels, Belgium; b Cross Cancer Institute, Edmonton, Canada; c Mount Vernon Hospital, Northwood Middlesex; d Southampton University Hospital NHS Trust, UK; e Université catholique de Louvain,Brussels; f University Hospital Ghent, Belgium; g Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland; h Institute Verbeeten, Tilburg, The Netherlands; i Geneva University Hospital, Switzerland; j Catharina Hospital, Eindhoven, The Netherlands article info Article history: Received 23 October 2011 Received in revised form 10 April 2012 Accepted 24 April 2012 Available online 23 May 2012 Keywords: Quality assurance Radiotherapy Clinical trial Platform Central review abstract Objective: Quality assurance (QA) in clinical trials is essential to ensure treatment is safely and effectively delivered. As QA requirements have increased in complexity in parallel with evolution of radiation ther- apy (RT) delivery, a need to facilitate digital data exchange emerged. Our objective is to present the plat- form developed for the integration and standardization of QART activities across all EORTC trials involving RT. Methods: The following essential requirements were identified: secure and easy access without on-site software installation; integration within the existing EORTC clinical remote data capture system; and the ability to both customize the platform to specific studies and adapt to future needs. After retrospec- tive testing within several clinical trials, the platform was introduced in phases to participating sites and QART study reviewers. Results: The resulting QA platform, integrating RT analysis software installed at EORTC Headquarters, permits timely, secure, and fully digital central DICOM-RT based data review. Participating sites submit data through a standard secure upload webpage. Supplemental information is submitted in parallel through web-based forms. An internal quality check by the QART office verifies data consistency, format- ting, and anonymization. QART reviewers have remote access through a terminal server. Reviewers eval- uate submissions for protocol compliance through an online evaluation matrix. Comments are collected by the coordinating centre and institutions are informed of the results. Conclusions: This web-based central review platform facilitates rapid, extensive, and prospective QART review. This reduces the risk that trial outcomes are compromised through inadequate radiotherapy and facilitates correlation of results with clinical outcomes. Ó 2012 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 103 (2012) 279–286 Quality assurance (QA) in multicentre international clinical tri- als is essential to ensure that radiation therapy (RT) is safely and effectively delivered. The QA strategy of the EORTC Radiation Oncology Group (ROG) has been in place since 1982 [1]. The pio- neers of QA within the ROG established the culture and basic prin- ciples of clinical trial QART in Europe. Over the past 30 years, attempts to ensure quality RT delivery have included site visits, evaluation of institutions’ staff and infrastructure, dosimetric checks of treatment units, cross-check of patient charts and portal images, radiobiological modelling of inter-institutional differences, and mailed thermoluminescent dosimetry audits [2]. Efforts have consistently reflected what is considered state-of-the-art given available human and financial resources. In 2006, five levels of QA were defined at the EORTC, including specific QART requirements for participation in ROG trials [2]. In the dummy run (DR), investigators are provided with relevant clin- ical and radiologic information on an index patient, and are asked to treat the case as if it were entered into that trial protocol. The ability to appropriately contour target volumes and produce a compliant treatment plan is evaluated by trial QA reviewers. The individual case review (ICR) confirms protocol compliance with RT parameters for specific patients including target delineation, beam configura- tion and dose verification. To maximize the validity of the review, the full RT dataset should be evaluated, often including diagnostic images on which the RT plan is based. ICR datasets are evaluated by members of the trial QA committee, either retrospectively or prospectively (in relation to timing of RT delivery). DR and ICR data- sets are evaluated as acceptable, minor or major deviation, and a customized report is delivered to the submitting institution. Major deviations trigger compulsory DR resubmission and in the case of 0167-8140/$ - see front matter Ó 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.radonc.2012.04.015 ⇑ Corresponding author. E-mail address: alysa.fairchild@albertahealthservices.ca (A. Fairchild). Radiotherapy and Oncology 103 (2012) 279–286 Contents lists available at SciVerse ScienceDirect Radiotherapy and Oncology journal homepage: www.thegreenjournal.com