Shared Resource: Information Systems

November 3, 2015
By: Karen E. Butler, Director of Communications, DCI

From front to back: Front left – Erin Wood, IT Analyst; Chad McLamb, Senior IT Analyst; Stephen Adams, Linux System Administrator; Right, Manuel Rosa, IT Analyst; Bose Kamineni, Manager, Application and Database; Michael Goodin, IT Analyst; Seth Fehrs, IT Analyst; Tim Steele, Clinical Research Informatics Manager. (Missing: Mark Peedin, Senior IT Analyst; Michael Leonard, Project Coordinator III; Geoff Chenger, Helpdesk Manager; Adebola Jokogbola, IT Analyst; Aaron Crallie, IT Analyst)Duke Cancer Institute Information Systems (DCI-IS) is a shared resource comprised of personnel and sophisticated computer software that process or interpret information to support clinical, translational and basic biomedical research.

“Our mission is to provide comprehensive computational support to enable researchers to use technology in the most efficient manner possible to accomplish their research goals,” said Tim Steele, MBA, clinical research informatics manager. “Most DCI members are not experts in information technology and thus require some level of staff support to ensure optimal use of the shared resource.”

The resource provides infrastructure, personnel, technical support, assistance and consultation for database development, application development, servers and web applications. The staff of the DCI-IS provides any level of support necessary, including designing clinical trials and eCRF’s and implementing entire systems.

“Data availability, reliability and security are essential to clinical trials,” said Steele, who first joined Duke in 2011 to serve as a senior manager at Duke Health Technology Solutions (DHTS). “To ensure those essential elements, we offer a service using a product known as Medidata RAVE. Medidata RAVE, an electronic data capture (EDC) application, facilitates the efficient management of oncology clinical trials data. ”

Through template form eCRF (electronic case report form) content, custom edit checks and flexible design tools the application provides optimal data entry experience and CRF Part 11 compliance for electronic records.

Chad McLamb, Web Services Administrator, and Tim Steele, Clinical Research Manager, review settings in the computer room, which houses all the server compute and storage used by users and departments throughout the DCI. The server environment is comprised of both physical stand-alone servers and an environment of virtual servers. The room is environmentally controlled with multiple layers of access control to ensure the data is physically secure. All data within the room is routinely backed up and stored offsite for disaster recovery and help ensure business continuity.The companion application, Medidata BALANCE, gives study statisticians a tool to generate patient treatment assignments for randomized clinical trials. Through permuted block assignment BALANCE interfaces with RAVE to produce randomization records and notification of subject enrollment. BALANCE automates a process traditionally handled manually providing dependable management of patient records.

The resource also provides web, server and desktop support for more than 1,000 DCI staff, members and their laboratories. In addition, DCI-IS personnel collaborate on an ongoing basis with DHTS on enterprise level IT efforts and programs.

“We are an agile, experienced team, highly skilled in cancer research related IT,” Steele said. “We provide expeditious response to complex and intricate requests.”

The DCI-IS service desk is open weekdays from 8 to 5 p.m. Twenty-four-hour emergency assistance is available by pager. An online form for DCI-IS Needs Requests has been created to facilitate centralized prioritization of service requests, specifically including clinical trial support, application development and database development projects. Non-emergency inquiries can be made through the online needs request form at any time. To access the online form, visit DCI-IS Needs Requests.