Campus Alert: Find the latest UMMS campus news and resources at umassmed.edu/coronavirus

Search Close Search
Page Menu

NIH Resources Section

Data Capture Systems at UMMS

a)    OnCore & EPIC: Operations data from clinical trials at the UMMS is collected using a Clinical Trials Management System (CTMS) called OnCore (Online Collaborative Research Environment) which helps to manage all aspects of our clinical trial operations.  UMass Memorial Healthcare, UMMS’ clinical partner uses EPIC as the Electronic Medical Record system.  OnCore is a comprehensive web-based CTMS that seamlessly integrates Scientific Review, Protocol Management, Calendaring, Budgeting, Subject Management & Tracking, and Financials. Furthermore, OnCore is integrated with EPIC so that Patients on trials are linked in Epic and study enrollment information is shown in the Patient Header in EPIC. This helps in alerting treating physicians that a patient is on trial to ensure patient safety and protocol compliance. The research study team contact information is also linked such that the study team can be alerted when/if a patient gets admitted in the hospital. Additionally, the integration helps in marking procedures linked to research, enabling appropriate billing. In addition, EPIC MyChart and Best Practice Advisories (BPAs) are also utilized as part of the patient recruitment tools in standard clinical research.   

b)    REDCap: UMMS is a member of the REDCap Consortium (http://project-redcap.org). REDCAP is used at UMMS for collection of data for research, quality and operations projects. Our REDCap implementation supports 2344 projects and 930 users.

c)     Conquering Disease Registry and Consenting System: We have implemented a registry and consenting system for patients to express their interest in upcoming research studies and consent to future contact. The system was launched in 2016 and has over 1500 patients already registered.

d)    OpenSpecimen: Biospecimen collection for research projects at UMMS is enabled by OpenSpecimen, an open source application developed originally through the Cancer Biomedical Informatics Grid Project from the National Cancer Institute. OpenSpecimen facilitates protocol-based collection of fecal samples, barcoding, storage, management, and distribution of stool samples and derivatives (DNA).

e)    LabArchives & Synergist: We collect sample, experimental-protocol, and instrumentation details (metadata) and results in LabArchives, the institutional Electronic Lab Notebook (ELN). Additionally, data can be annotated in Synergist, a graph-based metadata management and analytical pipeline system built by the UMCCTS Informatics core to enable exchange and sharing of data.

Data Integration and Visualization

a)    Integrated Data Repository: Clinical data collected as part of routine care is integrated into the UMMS Data Lake (DLR) and is used for retrospective research, assessment of clinical trial feasibility and to assist in clinical trial recruitment with appropriate IRB permissions. Extensive QA/QC procedures are being implemented to ensure data consistency and accuracy.

b)    Cohort identification Tools: UMMS has implemented i2b2 and TriNetX to assist in cohort identification for clinical trials and retrospective studies. UMMS was among the first to adopt the i2b2 framework, now implemented at many academic health centers. UMMS is an active participant in the i2b2 tranSMART Foundation.

UMMS Secure Data Environment

Significant emphasis is given at UMMS to ensure secure and compliant access to data. In 2010 UMMS completed construction of a data center to house compute servers and storage devices for administrative, research and educational computing at UMass Medical School. The data center has physical and logical controls in place to enable secure storage and handling of sensitive electronic data including protected health information (PHI) and protected personal information (PPI). Access into the Data Center is protected by electronic badge and biometric authentication systems. Video surveillance is also in place as appropriate to monitor access to the data center. UMMS has implemented encryption policies for laptops and portable computers. All institutional computers are password protected and there is no access to the LAN, Mainframe, or PC without a password. Additionally, the high performance computing center (the UMass – Massachusetts Green High-Performance Computing Center [UMass-MGHPCC]), and the HIPAA Compliant and FedRAMP, SOC 1-2-3 certified Cloud Computing environment through Amazon Virtual Private Cloud (Amazon VPC) (1), facilitates high-throughput data analysis and multi-site/remote secure data collection. UMMS has deployed over 12,000 cores of HPC, with 2.42TB RAM, 60TB high-speed storage at UMass-MGHPCC for investigator-initiated computational studies. There is an additional 600TB of network storage and 2.0PB archival storage specifically for research needs. UMMS has designed its network topology to support the needs of translational research.

UMMS IT infrastructure performs the necessary nightly backups of the systems for disaster recovery. The AWS environment will enable us to do real-time Disaster Recovery for applications that need high availability/redundancy.

Data Access for Researchers

Electronic access to sensitive data resources has been controlled using IRB and institutional guidelines.  Members of the UMMS Data Science and Technology (DS&T) team, directed by Jomol P. Mathew, Ph.D., who have administrative access to the clinical data and clinical research applications are trained in CITI and Security principles. All study personnel with access to PHI will have appropriate IRB (e.g., CITI) and security training. Additionally, PHI/PII data containing applications like Oncore and REDCap have application level security enforced through user id and password. Data will be de-identified for sharing with the larger research community.

 

Source documents include all recordings of observations or notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the clinical study. Accordingly, source documents include, but are not limited to, laboratory reports, ECG tracings, x-rays, radiologist reports, subject progress notes, hospital charts or pharmacy records and any other similar reports or records of any procedure performed in accordance with the protocol. If utilized, hard copy data of patient information for research is maintained in locked and secure cabinetry within the office of the study coordinator. Access to the PI laboratories is carefully controlled by school security.