Advances in information technology continue to have a profound impact on the conduct of healthcare research. Our mission is to evaluate, develop and provide novel IT solutions to problems in healthcare research, with an emphasis on the development of web-based systems to support novel clinical trials and observational study designs. Our electronic data capture (EDC) systems provide features to support complex data entry, with reporting and notification workflows involving core labs, event adjudication committees, sponsors and regulatory agencies.
Research Informatics Core
The Research Informatics Core offers the following expertise:
- Web-based Data Collection Systems - The informatics group was one of the pioneers in the use of remote electronic data capture (EDC) systems for clinical trials in the 1990s, and the group has built and maintained a large number of web-based EDC systems for government and commercially sponsored clinical investigations, including:
- The NHLBI-sponsored Cardiothoracic Surgical Trials Network
- The FDA-sponsored PANDA study of long term effects of exposure to anesthesia during pediatric surgery
- The NINDS-sponsored ARUBA trial for unruptured brain AVMs
- The TWILIGHT Trial, a blinded drug study to evaluate anti-coagulation options with more 140 clinical sites in North and South America, Europe and Asia
- Our clinical trials systems support a number of features to bring down the cost of conducting trials and enable complex or unusual designs:
- Anonymized source documents, uploaded as electronic attachments to CRFS to enable remote monitoring of clinical sites
- Image study files can be uploaded directly into the EDC system for evaluation by a core lab
- A variety of randomization schemes are supported, and customized schemes can be built to enable web-based randomization of trial patients. Several trials have used our EDC systems to randomize their subjects while they are in the operating room
- Online drug inventory tracking and bottle assignment for blinded, randomized trials
- Option to include a human gatekeeper function during the screening process
- Enterprise Event Reporting Systems for Patient Safety - The Research Informatics Team developed Mount Sinai's medical event reporting system (MERS), which was marketed by General Electric for use in hospitals across the country. We have built HL7 interfaces at a number of hospitals to merge patient demographics and hospital location data with incident reports, and we participated in a pilot project using RFID technology to automatically generate an incident report when hospital personnel entered a patient room without pressing a soap dispenser to wash hands.
- Web Based Reminder and Notification Systems - We built a web-based reminder and notification system to facilitate communication between oncologists and treatment providers for breast cancer patients, which is currently being evaluated in a multi-center trial.
- EDC System Integration with Routine Clinical Encounter Data - We are developing new EDC system designs that can bring down the cost of health care research by integrating with other hospital systems and enabling investigators to develop their own web-based data entry systems
The research informatics group provides systems to assist investigators with their data and document management needs for research projects of all sizes, from large, multi-center studies, FDA regulated trials for industry, patient registries, and investigator-initiated projects. We develop and support a wide range of systems for clinical data entry, telephone surveys, controlled document management, issue tracking, and email notification systems, as well as informational web sites for the general public.
- REDCap - The group currently provides REDCap services for low-cost web-based EDC. Our REDCap servers and support are available to enable investigators to develop their own web-based clinical data capture tools that support regulatory compliance.
- Data Management Plans - We are available to assist investigators with the development of their data management plans for pilot projects, grant applications, and IRB submissions.
- Novel Solutions for Complex Workflows - We collaborate with innovators to develop novel software solutions to health care problems, particularly in areas involving complex workflows, tracking, access control and notification rules, and interfacing with other hospital systems.
Server Capacity - A cluster of nine rack mounted servers and two drive arrays located in Mount Sinai's secure data center is available to provide redundancy and ample storage for large web-based data management projects involving hundreds of hospitals and thousands of users.
Security Procedures - Our security procedures are based on NIST 800-53 and our quality management system is based on ISO 9001:2008. Systems used in FDA trials comply with 21 CFR 11 and FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations.
Ron Levitan, Dipl Comp Sci
The System Development Team