Jun Zhang PhD, Presenter: Nothing to Disclose

David Poon BS, Abstract Co-Author: Nothing to Disclose

Preethi Subramanian, Abstract Co-Author: Nothing to Disclose

Richard Jacko BS, Abstract Co-Author: Nothing to Disclose

Nathan C. Hall MD, PhD, Abstract Co-Author: Consultant, Enlyton, Ltd

Michael Vinzenz Knopp MD, PhD, Abstract Co-Author: Nothing to Disclose

Kristin Sullivant, Abstract Co-Author: Nothing to Disclose

Ajay Siva, Abstract Co-Author: Nothing to Disclose

Stephanie Telek, Abstract Co-Author: Nothing to Disclose

Andrea Markowitz, Abstract Co-Author: Nothing to Disclose

Talha Saif, Abstract Co-Author: Nothing to Disclose

Michael Finneran, Abstract Co-Author: Nothing to Disclose

Katherine Binzel BS, Abstract Co-Author: Nothing to Disclose

Joe Milacek, Abstract Co-Author: Nothing to Disclose

To introduce and evaluate the workflow, standard and database established at the Alliance Imaging Corelab for cancer imaging quality control in multi-institutional clinical trials

The imaging Corelab (ICL) established an overall clinical trial implementation pipeline from trial initiative to trial closure. Along the roadmap, workflows of data quality control were defined with more than 15 individual sub-components integrated (site credentialing, virtual site visit, automatic quality check, real-time image remote review and so on). Quality control standard in 15 items under 4-level categories (timing, imaging, data and patient) was established with SOP driven. (Semi)-automatic softwares were developed enabling mega-data processing and database management in 10 important steps and audit process.

A total of 2992 patients with 8246 studies (PET/CT, CT, MR, NM) from 27 clinical cancer trials over 300 participating sites within USA were included in this assessment. The established thin-client real-time image review approach enables off-site reviewers performing remote image review with no data transfer required; a success rate of better than 91% in adaptive trials has been achieved in evaluating over 1500 real-time central reviews of which 75% enabled <24-48hour turn-around time from data receipt to central review results notification. Clinical trial dedicated software streamlines the overall workflow of mega image data processing and database management. It revealed 86.7% (compliant), 11.7% (acceptable) and 1.6% (non-compliant) of a total of 1502 trial patients participating in 6 adaptive trials; of which the most common imaging protocol violations are summarized

Quality control is critical component of cancer imaging clinical trials to assure appropriate executions and the success of clinical trial. The study proposed and evaluated our established workflow, standards and database of quality control in 10-yr multi-institutional clinical trials implementations experiences at the imaging corelab with efforts in helping people better understand the components, challenges and strategies of doing quality control for clinical trials.

Conducting multi-institutional clinical trials requires a set of standards and workflows in quality control defined for professional trial implementations making sure trials to be valid and successfu

Zhang, J, Poon, D, Subramanian, P, Jacko, R, Hall, N, Knopp, M, Sullivant, K, Siva, A, Telek, S, Markowitz, A, Saif, T, Finneran, M, Binzel, K, Milacek, J, Workflow, Standards and Database of Quality Control in Multi-institutional Clinical Trials of Cancer Imaging at the Alliance Imaging Corelab.  Radiological Society of North America 2013 Scientific Assembly and Annual Meeting, December 1 - December 6, 2013 ,Chicago IL. http://archive.rsna.org/2013/13027897.html