EORTC Radiation Oncology Group quality assurance platform: establishment of a digital central review facility.
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 therapy (RT) delivery, a need to facilitate digital data exchange emerged. Our objective is to present the platform 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 retrospective 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, formatting, and anonymization. QART reviewers have remote access through a terminal server. Reviewers evaluate 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.
EORTC Headquarters, Brussels, Belgium. alysa.fairchild@albertahealthservices.ca
Alysa
A
Fairchild
Edwin
E
Aird
Paul A
PA
Fenton
Vincent
V
Gregoire
Akos
A
Gulyban
Denis
D
Lacombe
Oscar
O
Matzinger
Philip
P
Poortmans
Pascal
P
Ruyskart
Damien C
DC
Weber
Coen W
CW
Hurkmans
D003195:Computer Communication Networks / Q000592:standards*; D005060:Europe; D006801:Humans; D016247:Information Storage and Retrieval / Q000592:standards; D015337:Multicenter Studies as Topic; D011785:Quality Assurance, Health Care; D018787:Radiation Oncology / Q000592:standards*; D011873:Radiology Information Systems / Q000592:standards*; D011878:Radiotherapy / Q000592:standards; D012984:Software