For clinical and translational investigators, it may have been the norm 5 years ago to store clinical research data in homemade databases. But laptops and flash drives are vulnerable to loss and theft; and errors of duplication and transposition can haunt XL spreadsheets. “Every P.I. is responsible for preserving the privacy of information. The breaching of data is associated with serious ethical and financial costs,” according to Lucila Ohno-Machado, MD, PhD, Professor of Medicine and Director of the CTRI Biomedical Informatics Division.
The CTRI and UC San Diego Health Sciences invested in Velos, a comprehensive clinical trials software management system, to ensure that large trials and their biorepositories are protected and data are transferred directly from the EPIC system, to minimize errors. The Velos pilot was initiated in 2011, and the system is now ready for use by a large community of investigators. The system is available to researchers as well as to directors of biorepositories. Users can store their data on and access it from a secure CTRI server, at no charge. This last feature is significant because acquiring software systems and maintaining them are expensive, both in terms of the software and the recruitment of the highly qualified people needed to operate and maintain them.
In addition to possessing all the functionality of REDCap, this clinical trial management system can do much more; for example, it
- Connects to EPIC, allowing investigators to obtain patient demographics and to schedule studies
- Has all the features of a proper, relational database: It is secure, searchable, archivable, customizable, automatable, and permits electronic data capture (patient visit tracking, Case Report Forms; tracking of adverse events)
- It is housed in a secure datacenter, properly maintained to assure data security, integrity, and availability, and is supported by dedicated, approachable, expert CTRI staff. They are available to train, consult, and provide a wide variety of services for interested research teams
With so many advantages, it is not surprising that the use of Velos is spreading throughout UC San Diego. Currently it is used in clinical studies involving approximately 1500 patients and representing ~210 users among diverse departments and divisions (Pediatrics, Ophthalmology, Rheumatology, Internal Medicine, Pathology, and the CTRI clinic, for example).
If you are interested in learning about Velos, Andrea Barker, CTMS Administrator, will be happy to discuss and demonstrate Velos and answer any questions you may have. Free training sessions are available on- and off-site. You can contact her at email@example.com or (858)657-5146.