Clinical Informatics

The Stanford Center for Clinical Informatics (SCCI) provides a variety of services to facilitate clinical and translational research:

• Access to SUMC Clinical Data for Research Purposes
• Research Data Management Solutions
• Real-time Research Alerting
• Biospecimen Data Management
• Privacy and Security
• SCCI consultants can also help review your project's data management and informatics needs and assist with developing a budget and Informatics/IT support proposal section for your grant prior to submission.
• For additional information, schedule a free consultation.

Stanford Cancer Institute Research Database (SCIRDB) will consult with you about research data management for cancer and disease groups. For additional information, send e-mail to ccdb-consult@lists.stanford.edu with a brief description of your research interests.

Stanford Center for Clinical Informatics (SCCI) consultants will help review your project's data management and informatics needs and assist with developing a budget and Informatics/IT support proposal section for your grant prior to submission.

Stanford Cancer Institute Research Database (SCIRDB) personnel work with you to plan for your needs related to cancer projects. The ideal engagement occurs when either you are formulating the project or writing the grant application. The planning phase involves:

• Determining the duration and requirements of the project
• Determining how the investigators would interact with project data
• Estimating the resources (hardware, software, and personnel) needed for a project
• Charting a timeline for execution of the deliverables with specified milestones

A key focus of the activities of the Stanford Center for Clinical Informatics (SCCI) is the Electronic Health Record (EHR), and how the EHR can support the development of evidence-based medicine through translational, clinical and outcomes-based research, while ensuring the security and privacy of individual patient information.

SCCI is the official SUMC clearing house for all clinical data requests related to research. With access to clinical data from the Electronic Health Records of both hospitals, SCCI can meet your clinical research data needs, either via our self service online tools or with an in person consultation.

The Stanford Center for Clinical Informatics (SCCI) can provide you with sophisticated biospecimen data management tools.

You can also our online search tool to search for biospecimens in several biospecimen banks supported by STRIDE.

Stanford School of Medicine offers a number of data capture platforms to facilitate clinical research, all of which are recommended over the more traditional choices of Excel, Filemaker Pro and Access, since all three satisfy the HIPAA Privacy Rule requirements.

• STRIDE-DM, the Data Management application development platform of the Stanford Translational Research Integrated Database Environment, was developed by the Stanford Center for Clinical Informatics (SCCI). It supports the design of custom research data capture systems and also offers integration with the STRIDE Clinical Data Warehouse, which contains both current and historic clinical data from both LPCH and SHC. STRIDE-DM research data management systems are all custom-built by SCCI application developers in exchange for salary support to cover the time spent building the database. There is an annual maintenance fee.
• REDCap is a self-service system where the researcher defines the database fields either in a spreadsheet or with the help of user-friendly web tools; once the database fields have been finalized, you can start entering data immediately. SCCI offers complementary support during the process of defining and refining your database. There is no annual maintenance fee, thanks in part to funding from the Stanford CTSA (Spectrum).
• STRIDE Secure Workbench is a remote desktop platform allowing researchers to analyze sensitive data with 3rd party software in a secure environment.
• Additional commercial products are also available, such as Medrio (frequently used in drug trials), or Oracle Axis.

Stanford Cancer Institute Research Database (SCIRDB) consults on research data management for cancer and disease groups. Patient data can be provided in formats such as:

• A custom web-based display that shows columns of data for the fields identified in the data dictionary.
• A REDCap database that allows researchers to browse and edit entries for each patient.

The SCIRDB infrastructure offers the following technological capabilities to clients.

• Modern database management with entry and access over the Web when necessary with rigorous attention to the quality of the data
• Establishment and maintenance of databases that can be scaled to increase in size seamlessly as they evolve in terms of hardware, algorithms, and needs of particular projects
• Development of tools for rapid prototyping of data forms and relationships among sources of data, including porting data from laboratory instrumentation to integrated central databases
• Provision of access to various secondary databases, including extensive links to publicly available databases

The STRIDE Clinical Data Warehouse contains electronic clinical data from both SHC and LPCH, including patient demographics, ICD-coded diagnoses, CPT-coded procedures, clinical documents, surgical pathology reports, radiology reports and laboratory test results.

Consultants from the Stanford Center for Clinical Informatics (SCCI) can review the clinical data needs of your research project, provide advice on requesting IRB approval to obtain clinical data from STRIDE and discuss options for clinical data abstraction, reporting and storage to meet your research needs.

SCCI is the official SUMC clearinghouse for all clinical data requests related to research. With access to clinical data from the Electronic Health Records of both hospitals, SCCI can meet your clinical research data needs, either via our self service online tools or with an in-person consultation.

• Consultation – Implementing a database
  The Center supports two research data management options: Custom research data management applications built on the STRIDE platform and databases created in a standalone self-service database (REDCap).
  
  During an in-person consultation, center consultants will review options and discuss the tradeoffs of various approaches. We can also summarize research data management best practices and describe the support that we can provide to you toward meeting regulatory requirements such as FDA Part 11.


• Technical Consultation – For the Research Coordinator/ Data Manager
  This technical consultation is intended primarily for a research lab's data manager. You will be given a review of the online data management tools (REDCap) and application development infrastructure provided by the Center to SoM research projects. The review will give you an understanding of the benefits and restrictions of each tool, as well as the technical competence required to use each one. One-on-one hands on training in getting started with building REDCap databases can also be provided.

Key Points

• Contact SCCI as early as possible in the design phase of a research project and preferably well in advance of IRB submission.
• If the scope of the project exceeds four hours of our time, funding may be required to complete the project.

Stanford Center for Clinical Informatics (SCCI) consultants will review options for research data management. The consultant will:

• discuss the tradeoffs of various approaches, including REDCap, STRIDE Secure Workbench, STRIDE-DM, and commercial software
• summarize research data management best practices and
• describe the support that SCCI can provide to you toward meeting regulatory requirements such as FDA Part 11.

Stanford Cancer Institute Research Database (SCIRDB) will consult with you about research data management for cancer and disease groups.

Stanford Center for Clinical Informatics (SCCI) consultants will:

• review your research project from a HIPAA perspective
• help identify areas of risk
• provide recommendations to achieve regulatory compliance and follow data security best practices

Consultants will also provide assistance in:

• meeting data privacy and security requirements for IRB submission
• biomedical research privacy and security regulatory compliance
• securing PHI on your computer

The Stanford Cancer Institute Research Database (SCIRDB) provides cancer investigators with a secure environment to store their data. We implement measures for both physical and data security. We use Secure Socket Layer (SSL) connections when providing researchers to role-based access the data over the web. We continuously monitor and upgrade security procedures as necessary. We work with the Stanford University Privacy and Data Security Officer to comply with all HIPAA regulations as they pertain to a project.

The STRIDE Cohort Discovery Tool provides a self-service method for asking questions to help identify a cohort of patients for a potential study. Search criteria can include demographics, diagnosis and procedure codes (ICD-9 and CPT), test results, and text search of clinical documents. This service is provided by the Stanford Center for Clinical Informatics.

For Cancer-related patient cohorts contact Stanford Cancer Institute Research Database (SCIRDB). We can help you build a cohort using diagnoses, procedure codes (ICD-9 or ICD-O), and billing codes (CPT). We can help you do complex searches involving dictations and other notes and we can identify which people have tissue stored in the Stanford Tissue bank.

Spectrum supports the development of innovative informatics solutions that address major barriers to effective CTR research both at Stanford and across the national clinical research enterprise. In addition to ongoing research and development, services are provided to assist the investigator with informatics and data management needs.

Consultation services and assistance are provided by the Stanford Center for Clinical Informatics and include:

• Access to data from the Electronic Health Records at Stanford Hospital and Clinics and Lucile Packard Children's Hospital for research purposes.
• Research data management solutions for both small and complex research projects.
• Biospecimen data management software and services.
• Research privacy and security assistance.

For more information visit the SCCI website.