Electronic Data Capture and Surveys
We help you navigate the pros/cons of all EDC options (commercial, open source, and academic) depending on your needs.
- REDCap Cloud
Research IT helps teams evaluate survey and mobile technologies for capturing moderate- and high-risk research data directly from research subjects, research workflow, and end-point devices. Limitations on what you can effectively use will depend on the data risk, data volume, license model, and services available.
The Reseach IT team manages and enhances Stanford’s PHI compliant REDCap platform, and has developed ~100 custom modules that are used in Stanford studies. Some of our modules are now core parts of REDCap software. Both REDCap Cloud and Forte (part of our OnCore institutional license) are 21 CFR Part 11 compliant standalone cloud products.
Computational and Data Storage Solutions
We’ll assist you with all the operational challenges.
- Hardware selection
- Long-term data storage
- Secure data sharing
- ISO minsec requirements
- Vulnerability management
- Connecting with solution providers
- Understanding operational costs
Long-term storage and secure sharing of moderate- or high-risk data continues to be a challenge. Based on your project's need and your lab's skill set, we can recommend solutions and connect you to on-premise solution providers.
Stanford has an ongoing institutional initiative to support researchers using cloud for high-risk data. If you are considering cloud for medium- or high-risk data, it is not sufficient that SoM has a BAA with cloud providers. It is SoM/researcher responsibility to implement ISO minsec requirements, which are not trivial. We can help you navigate pros/cons of cloud options – rolling your own vs. institution-supported.
If you are considering buying hardware for moderate or high risk data, we can help you get a better understanding of your fully-loaded operational cost.
Even if your project does not require Research IT staffing, we can help you develop budget plans, timelines, and cost estimates for operationalizing and maintaining the technological portion of your grant. Resources for grant writing »
The Research IT team specializes in writing production software that gathers, stores, and analyzes PHI data according to HIPAA requirements. We coordinate with Stanford data hosting teams to support integrated systems that run on secure hardware or cloud infrastructure. We can customize existing infrastructure solutions, build custom software specific to your workflow, deploy and manage systems requiring long-term support, and more.
Complex Event Processing (CEP) Engine
Research IT has a Complex Event Processing (CEP) engine on a live HL7 message feed of clinical events from both SHC and SCH. Lab and pharmacy orders, lab results, patient admits, transfers, and discharges and other essential messages can be used to configure real-time alerts.
The components of the system are:
- A set of trigger rules that define events, sequences of events, or even failure to appear of anticipated events in a given time frame
- A set of lookup tables derived from the Clinical Data Warehouse to supply additional context as needed in determining whether a rule should fire
- An event processing engine that applies the trigger rules to the log of recent events driven by
- The stream of incoming events from the HL7 feed
- The set of rules defining significant patterns in the event stream
- Integration with a lookup table
- A secure HIPAA-compliant notification engine that emits alerts when directed to do so by the event engine. Our current implementation sends a secure email to the physician's smart phone.
March of Dimes Prematurity Research uses a CEP alert to study causes of prematurity as a step toward developing ways to prevent it. Premature birth is a complex problem with no single solution. About 380,000 babies are born prematurely each year in the United States. In about half of cases, the cause is unknown.
CHOIR: A Learning Healthcare System
CHOIR (Collaborative Health Outcomes Information Registry) is a nimble Learning Healthcare System (LHS) under active development at Stanford and used by numerous academic medical centers in the US and abroad. It is used to monitor health status and outcomes for tens of thousands of patients at SHC and LPCH as part of clinical care, quality improvement, and research, and is customizable for clinical practices and research studies.
Patients receive email requests to complete their assessments at various times (for example, prior to an appointment or after an intervention), and they can complete these assessments at home using their phone or computer, or at the clinic using a provided tablet. Results are made available to the doctors for clinical care, and can be accessed for quality or research purposes. Assessments typically use standard NIH PROMIS instruments with computer adaptive testing to improve scoring accuracy while minimizing patient burden, and usually contain other custom content and scoring/branching logic as well.
REDCap Data Capture and Storage
REDCap (REsearch Data Capture) is a secure, reliable, versatile, and feature-rich HIPAA compliant database for storing research study data. REDCap allows you to design your own custom research data capture forms, survey study subjects, collect data longitudinally, organize your data collection instruments into arms, schedule email reminders, randomize, and much more.
REDCap base software is written by members of REDCap Consortium and globally supports over 545,000 users and 420,000 projects at 2,300 institutions in 110 countries. It is deployed at Stanford by Research IT and available to all Stanford researchers. Our deployment currently supports over 150 concurrent users each day, over 250 new projects per month, 600K logged user events per month, and 1.3M logged page hits per month.
Research IT has partnered with REDCap Cloud for FDA 21 CFR Part 11 Electronic Data Capture (EDC) compliance, which is required for clinical trials. We handle licensing and on-boarding. Please set up a consultation with us to explore your REDCap options.
Mobile Studies and Mobile App Backend Data Management
The mHealth server is a scalable, multi-tenant, HIPAA-compliant platform with APIs for registering participants and saving data gathered by mobile apps. Research IT can help you with:
- mHealth strategies
- best practices and pitfalls
- connections with existing solutions on campus, Stanford’s commercial partners, or
- other campus researchers
- custom mobile solutions
- custom mHealth server features
Custom Software Development
We routinely create secure, compliant, containerized, deploy-anywhere solutions with Java, PHP, Oracle, MySQL, PostgreSQL and more to manage high-risk data and ensure regulatory compliance.
Over the years, our solutions team and applications team have partnered with many departments and researchers on many projects requiring management of high-risk data and/or complex regulatory compliance.
Data Science Resources (DASHER) Consultation Services
If your needs are broad and diverse such as other data sources, study design/methodological questions, or help with interpretation, Stanford Data Science Resources (DASHER) can help you find the collaborations you need. Learn more »