Monday, November 5, 2012

Access to Clinical Data

source : https://clinicalinformatics.stanford.edu/services/clinicaldata.html


SCCI is the official SUMC clearing house for all clinical data requests related to research. Our clinical information is provided through STRIDE (Stanford Translational Research Integrated Database Environment). The cornerstone of STRIDE is a clinical data warehouse, integrating health information from both the Lucile Packard Children's Hospital (LPCH) and Stanford Hospital and Clinics (SHC) electronic health record systems, including both historical data and current EPIC and CERNER clinical data.
The following diagram illustrates a typical researcher workflow:
Research Data Reporting
Select a step to highlight

Hypotheses and Feasibility
EMR systems are primarily designed for patient management and billing. Using this data for research purposes can be challenging. We strongly encourage researchers to meet with us in the early stages of a project to gauge the feasibility of clinical queries and to help identify any nuances in the clinical data that could affect their interpretation of the data. This meeting is offered at no cost as part of the free informatics consultation service.
Cohort Identification
Researchers can determine if a cohort of suitable pediatric and/or adult patients exists in the STRIDE clinical warehouse by meeting with us in-person as part of a free informatics consultation, or by independently using the STRIDE Cohort Discovery Tool. The Cohort Discovery Tool is available to all Stanford research personnel with current HIPAA training.
SCCI Approval
Once a potential research patient cohort has been identified, the researcher submits the formal request to SCCI containing the initial cohort query, research question(s) formulated, and all clinical data elements they wish to review. If approved by the School of Medicine's Privacy Officer, the clinical data will be made available to the researcher as an identified or de-identified dataset through the STRIDE Patient Cohort Data Review Tool.
Data Review
The STRIDE Patient Cohort Data Review Tool (DRT) permits users to search across physician notes, labs, radiology and more. Users can include or exclude patients on an individual basis to form a curated cohort ready for export and analysis. As permitted by HIPAA, the DRT allows researchers to review clinical data for a potential research project; however no data can be copied, transcribed or used in any way until IRB approval is received. Upon completion of the data review, the researcher must then apply to the IRB for study approval.
IRB Approval
New research projects will require an approved IRB protocol to move forward. We can assist by supplying anonymous data reports, which typically take the form of the number of patients seen at Stanford matching your proposed research cohort profile.
If you are trying to apply an existing protocol to your extract, it will first be reviewed to ensure all requested data elements are covered. In some cases, the researcher must go back to the IRB to amend their protocol to include additional elements.
Data Extraction
With an approved IRB protocol and curated data review cohort, the researcher submits a formal request for data extraction from the STRIDE clinical data warehouse. After review of the application and an in-person meeting, a clinical informatics specialist on staff will develop the custom query and/or extraction tailored to the specific needs of the research study.
Data Analysis
Stanford and the Center for Clinical Informatics offer a number of research data management options in support of clinical research, including: REDCapSTRIDE Secure Workbenches,custom databases, and MedWiki-Secure. We strongly encourage researchers to consult with a statistician before beginning the analysis of their clinical data.

Cost and Credit

Inquiries and consultations on new research projects are always offered free of charge to Stanford community researchers. In general, we will provide up to four hours of labor working on a project before we need to discus setting up a payment plan. When additional payment is required, you will be responsible for covering the employees salary on an hourly basis for the time spent working on your project.
In projects where expert Informatics expertise is required the Center may engage in a collaborative partnership leading to co-authorship on related publications. In such a collaboration, and particularly where the work is of shared interest, we may be able to extend the duration of our no-cost services.
We ask that all research related to your consultation include appropriate citations to the resources used. Please see our citation information for details.

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