Major Clinical Trials Software and Data Warehouse Launched by the CTRI

The CTRI is pleased to announce two new informatics tools that will allow researchers to utilize medical records in a secure and compliant manner in their studies, and to employ powerful clinical trial management software. Implemented by the CTRI Biomedical Informatics Division under the leadership of Drs. Aziz Boxwala and Lucila Ohno-Machado, these and other advances will greatly speed and facilitate the conduct of clinical research in the San Diego region. Each of these services will be provided free of charge to CTRI members.

Velos eResearch Software for Clinical Trials and Sample Repositories

Velos eResearch is an integrated, powerful software system for managing clinical trials. In addition to providing a standardized platform, the software will ultimately link to the UCSD Health System’s Epic Electronic Medical Record System to provide improved information and integration for clinical research projects. With support from the Health System, the School of Medicine, and the CTRI, Velos was purchased, installed, piloted, and launched April 4, 2011. One module within this platform, called eSample, will track biological samples and link them to the Electronic Medical Records. A robust support team (see below) is already in place to assist investigators to implement their protocols, study budgets, and calendars in eResearch.

Clinical Data Warehouse for Research

The Clinical Data Warehouse for Research (CDWR) mirrors the Electronic Medical Record and will allow investigators to query the patient information in a HIPAA-compliant manner. A web interface developed by the CTRI known as CRIQueT allows investigators to obtain approximate counts of patients who match the eligibility requirements of proposed studies. This will enable the researchers to analyze the feasibility of proposed clinical trials. Where needed, the data are subjected to de-identification algorithms.

The data in the CDWR are drawn primarily from the clinical data warehouse at UC San Diego Medical Center. That warehouse contains data from more than 1.9 million patients collected during the last decade. It has data from 1.8 million outpatient visits, over 300,000 Emergency Department visits, and over 177,000 inpatient admissions.

Other Software Provided by Biomedical Informatics

REDCap (Research Electronic Data Capture) is a web-based application for creating databases for observational studies, and patient registries. It can be used by study teams to rapidly design data collection forms and reports, to export data into a variety of formats for analysis. A module within REDCap can be used to design and administer web-based surveys.

How Investigators Can Access Services

Researchers interested in using Velos, the CDWR, or other Informatics resources may contact Biomedical Informatics staff  ctri-informatics@ucsd.edu. Potential users may also be directed to Informatics resources by other CTRI Divisions, such as the Center for Clinical Research Services.

	Lucila Ohno-Machado, MD, PhD Director of CTRI Biomedical Informatics Department of Medicine	machado@ucsd.edu phone: (858)246-0227