1 UAMS-CRIS Comprehensive Research Informatics Suite at UMAS
2 Overview CRIS consists a group of web-based applications that are integrated together to facilitate study management, data collection, data submission, data analyzing, auditing and reporting. Not like other standalone solutions, CRIS is highly flexible and open. We may use the best part from each applications to provide full spectrum services for clinical researches. In addition, we can easily add new components or replace outdated components to enhance the suite. The IT Research group has years of experiences in successfully adopting & enhancing open-source informatics solutions, as well as developing web-based applications for clinical research.
3 CRIS and Related SystemsProtocol Management Clinic System Protocol Execution CLARA RPRS PSC EPIC Trial Search Lime Survey AERS Open Clinica Offline Interface Event Tracker Lab Grading caTissue LabKey Schedule & Lab Results U-Core caTies Pre-Screening FundationOne Adaptors i2b2 Data Analysis & Reports Protocol Timeline Report Visiting Reports Enroll Report Score Card Report Billing Report Other Reports
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5 Current Components in CRIS (1)Liferay Dashboard: host all components of CRIS; announcements; etc. Central Authentication System (CAS) for Single Sign-On (SSO): linked to UAMS LDAP for internal users; linked to a database for external users; we are working on InCommon SAML protocol to integrate with other institutes’ Identity Provider Services. Redmine: a ticket system for tracking user requirements, communication, progress and status. Note: we’ve switched to ServiceNow for tickets and project management. CLARA: the IRB approval and budget building tool.
6 Current Components in CRIS (2)EventTracker (ET): capture supplementary study related data; tracking submissions, study level services, delegation logs; tracking pre-study building process. TrialSearch (TS): a shortcut to search studies and access basic information of all clinical trials. Study information includes title, description, PI, contact methods, criteria, drugs/treatment, protocol documents, training documents and videos, etc. Research Participant Registration System (RPRS): hosts participant’s demographics, study registrations, consents, progress status (epoch or phase). Registration record can be sent to other CRIS components and EPIC. Participant Study Calendar (PSC): track/manage subject’s research visits and activities based on study calendar template. caTissue (CT): a comprehensive tool for specimen inventory management including tracking, annotation, transaction, etc.
7 Current Components in CRIS (3)LimeSurvey and Offline Survey (LS): an open-source tool enables users to quickly deliver questionnaires to respondents and collect responses. We developed an offline version so users can collect data at rural areas w/o internet. OpenClinica (OC): an open-source software for Electronic Data Capture (EDC) in clinical research. Users can build their customized Case Report Forms (CRF) so OC can be used for capturing customized data fields. We use OC to achieve 21 CFR PART 11 compliance. Adverse Event Report System (AERS): allows clinical research staff to collect adverse events for research participants using Common Terminology Criteria for Adverse Events version 3 & 4 (CTCAE v3 & v4) event definitions. EPIC lab results (other data sources can be added easily) are automatically graded and Lab AEs can be automatically created and/or resolved. Assessed AEs can be pushed to EPIC and OC.
8 Current Components in CRIS (4)Pre-Screening System (PSS): log nurses’ efforts for prescreening new patients into studies. LabKey: a free open source tool which can be utilized to analyze, integrate, and share biomedical research data. It can be used to track and analyze assays with flow cytometry, proteomics, general purpose assay tools. I2b2: with deidentified and/or obfuscated data, researchers can identify a cohort prior to starting a study. In CRIS, free text reports, biospecimen data, tumor registry data are pushed to the I2B2. caTIES: Text Information Extraction System which is being used for the deidentification and concept code generation of the surgical path reports of the specimen collected in caTissue. Mirth: an interface suite which is used for integration and data channels FundationOne: collecting gene data and generate reports SurgarCRM: used by Cancer Control to manage recruitment workflow.
9 Current Components in CRIS (5)Others: we had investigated/developed some other tools U-Core: manage core services and agreements. Faded out. SQL Server Reporting Services (SSRS): generate reports and ETL data files. Rewrote reports using script languages for flexibility reason. caBIG Adverse Event Reporting System (caAERS): Contains the definitions for reports of adverse events which might occur during the data compilation, transfer, extraction or production process. Processes and submits all AERs including electronic AERs, eAER. User doesn’t link it. caBIG Lab Adverse Event Grading System (CALAEGS): Auto- grading Common Terminology Criteria for Adverse Events (CTCAE) V3 and V4 for lab results. Rewrote in java. Talend: used for ETL in NCS project Open System for Entity Resolution (OYSTER): to identify duplicate references to one entity. Used in NCS project
10 CRIS Dashboard
11 Research Participant Registration System (RPRS)-- Subject Demographics
12 Research Participant Registration System (RPRS)-- Study Summary (1)
13 Research Participant Registration System (RPRS)-- Study Summary (2)
14 Research Participant Registration System (RPRS) -- Study Registrations
15 Research Participant Registration System (RPRS)-- Subject Registration Overview (1)
16 Research Participant Registration System (RPRS)-- Subject Registration Overview (2)
17 Lab Results -- viewable in RPRS
18 Participant Study Calendar (AR-PSC) -- Study Calendar Template
19 Participant Study Calendar (AR-PSC)-- Subject Calendar
20 -- Specimens of SubjectcaTissue -- Specimens of Subject
21 caTissue -- Specimen Details
22 LimeSurvey -- Input Response
23 LimeSurvey -- View Responses
24 OpenClinica (OC) -- Subject Matrix
25 -- Enter/Edit Data (Form)OpenClinica (OC) -- Enter/Edit Data (Form)
26 -- Enter/Edit Data (Grid)OpenClinica (OC) -- Enter/Edit Data (Grid)