TriNetX

If you are UMB faculty, you may already have a TriNetX account. First, attempt to log into https://live.trinetx.com/ using your UMB email and, when prompted, enter your UMID and password. Accepting all Cookies and using Chrome provides the best experience. Please take a moment to review the use manual the Enterprise Data & Analytics Research Informatics Core (RIC) team has created for your reference TriNetX Access Management Manual 

Requesting a TriNetX Account

Currently, only University of Maryland Medical System data and TriNetX Research Network data are available. 

• UMMS Epic Data* from 13 UMMS facilities (see Date Range of Data tab below for list of UMMS facilities). On the TriNetX Query Builder, select University of Maryland Medical System from the list of networks.
  • Patient demographics: age, gender, race, ethnicity
  • Encounters: Site of Care, Admit date
  • Diagnoses: billed, recorded at encounter
  • Lab Results:  panels, microbiology
  • Medications: ordered, administered, patient-reported
  • Procedures: surgical, imaging, rehabilitative, therapeutic

*Currently, UMMS genomics data is not available. UMMS data is patient-level only at this time with very little encounter-level data. Also, imaging data results/comments are not reported in the TriNetX output. 

• TriNetX Research Network Data - UMMS participates in the Research Network, a network of over 95 healthcare organizations. This data is aggregated, and you will not be able to drill down to individual participating center-level data. On the TriNetX Query Builder, select Research from the list of networks.

Data have been cleaned, curated, and more fully mapped to improve data quality and analysis. However, a few things you need to consider:

• How Current are the Data?
  • UMMS pushes updated data to TriNetX monthly. This is typical for the 70+ HCOs contributing data to TriNetX
• Erroneous Data Output:
  • If data pushed to TriNetX from the HCOs has errors - such as extreme high or low values due to sample mislabeling - the TriNetX data will contain those errors as well. TriNetX does not correct erroneous data.. As they do their quality checks, they will notify the institution of errors they discover. It is up to the institution to make corrections, if possible.  Corrections will not be appear until the next data push to TriNetX. Best practice is to enter valid ranges to avoid pulling erroneous data.
• Non-numeric Lab Values:
  • Most institutions, including UMMS, do not report numeric values for some labs that fall under or exceed a value threshold. Instead, the values are reported as text values, such as < 1.0 or >9.0 (contains less than or greater than signs).  Patients with a text value will not appear in your TriNetX query count because the query can only pull numeric values.  This means you may miss patients that meet your criteria.  If you request an UMMS Epic data pull, discuss how this can be managed. Identifying the records with text values becomes a manual process.
• Patient Counts:
  • UMMS has multiple hospitals. A patient will be included in the count for each, respective institution's count where they have received care. However, for the overall UMMS sum of patients, a patient will be counted only once. 

Researcher Must First Complete - at a Minimum - Basic TriNetX Training

A. REQUESTING UMMS EPIC DATA 

1. We recommend you validate your query with TriNetX’s Query Design Assistance team to ensure your query accurately reflects your research study aims. They can be accessed via the “Design Assistance” button on the bottom left corner of the TriNetX Study Workspace. More information on the Query Design Assistance team can be found at this website (note that a TriNetX account will be needed to access this link): https://support.trinetx.com/hc/en-us/articles/34601096597787-What-is-Query-Design-Assistance.
2. Once your query is validated, open the Query History panel on the right side of the Query Builder Tool and click the yellow “Request Dataset” button.
3. Click on the “Available Datasets” tab on the navigation panel on the left side of the Study Workspace.
4. The ICTR/UMMS Research Informatics Core (RIC) will be alerted and will follow up with you about the approvals needed to receive clinical data (IRB review as well as UMMS approval). 

 Suggested IRB language for approval to receive UMMS Epic Data

We will use the TriNetX Research Network database - a web-based tool for research population cohort and feasibility queries - that displays pooled, aggregate clinical data of dozens of academic medical centers and health care organizations (HCOs) that participate in TriNetX. The University of Maryland Medical System (UMMS) is one of the participating HCOs, allowing UMB researchers to view de-identified, aggregate data for cohort discovery. 

We will validate our queries using the TriNetX’s Query Design Assistance team to ensure our queries accurately reflect our research study aims. Once we validate our queries, we will request record level data by submitting an ICTR Resource Request. The request is reviewed by the ICTR for completeness and then forwarded to the ICTR/UMMS Research Informatics Core (RIC) Epic team for consultation.  Once the RIC team confirms IRB approval for the variables/domains needed for the study, the RIC team will move the record-level dataset to the UMB Secure Research Environment (SRE) Azure Virtual Desktop (AVD) for the PI of this protocol and the approved research team members on this IRB submission to access. No data can be moved out of this environment without UMMS approval. A data use or transfer agreement may be required,

More information about the UMB SRE and AVD can be found here https://www.umaryland.edu/cits/services/secure-research-environment-guidebook/. The SRE AVD is the required UMMS/UMB storage platform for TriNetX Research Network data downloads. The data cannot be moved from this environment without UMB and UMMS approval and other required approvals, such as Data Use Agreements from UMB/UMMS and assistance from the RIC team.

B. REQUESTING A TRINETX RESEARCH NETWORK DATASET

1. UMMS has joined over 90 healthcare organizations (HCOs) across the nation in allowing their Epic data to be pooled with the other participating HCOs.  This is a limited dataset (includes dates of service and events) and you WILL NOT be able to identify the data's associated HCOs.

We recommend you validate your query with TriNetX’s Query Design Assistance team to ensure your query accurately reflects your research study aims. They can be accessed via the “Design Assistance” button on the bottom left corner of the TriNetX Study Workspace. More information on the Query Design Assistance team can be found at this website (note that a TriNetX account will be needed to access this link): https://support.trinetx.com/hc/en-us/articles/34601096597787-What-is-Query-Design-Assistance.

1. Once your query is validated, open the Query History panel on the right side of the Query Builder Tool and click the yellow “Request Dataset” button.
2. Reach out to the ICTR to inform them of your request via ICTR-Navigator@umaryland.edu. They will need the following information to process your request:
   • A brief description of your research aims and the purpose of the dataset
   • Whether the study is grant-funded or non-grant-funded. For grant-funded dataset costs, please reach out to the TriNetX Healthcare Partnership Manager for UMMS, Chris Lugo, at chris.lugo@trinetx.com. Requests for datasets for non-grant-funded projects are provided at no cost.
   • How long you would like access to the dataset (the default is 1 year).
3. The ICTR will forward your information to TriNetX, who will reach out to you directly to review and return a signed Data Set Order Form, which outlines the Terms of Use for the dataset.
4. Once the form is fully executed, the ICTR will reach out with instructions on how to access the dataset.
5. You will need IRB review and an IRB determination letter to receive Epic Data from the TriNetX Research Network. 
6. The data set will be placed in the UMB Secure Research Environment (SRE) Azure Virtual Desktop (AVD) for the PI of this protocol and his research team on the IRB submission to access. If the PI requests, the UMMS Honest Broker can de-identify the limited data set by offsetting the dates of service and events. For the purposes of this project, I am requesting a [choose one: limited data set or de-identified data set] 

 Suggested IRB language for approval to receive TriNetX Research Network Data

We will be querying the TriNetX Research Network database, a web-based tool for research population cohort and feasibility queries that displays pooled, aggregate clinical data of dozens of academic medical centers and health care organizations (HCOs) that participate in TriNetX. The University of Maryland Medical System (UMMS) is one of the participating HCOs. No datasets are available at this point. At most, only limited datasets can be provided through the process noted below.

To obtain a limited dataset (includes dates of service and events), the PI of the IRB protocol will request the data from TriNetX who will follow up with the PI to discuss the purpose of the data request. If approved, TriNetX will work with the UMMS/UMB Institute for Clinical & Translational (ICTR) Research Informatics Core (RIC) (aka Honest Broker) to move a limited dataset from TriNetX to the UMB Secure Research Environment (SRE) Azure Virtual Desktop (AVD) for the PI of this protocol and his approved research team on this IRB submission to access. If the PI requests, the Honest Broker can, instead, provide a de-identify dataset in the SRE by offsetting the dates of service and events. For the purposes of this project, I am requesting that the Honest Broker place a [choose one: limited data set or de-identified data set (all 18 HIPAA identifiers removed)] within the SRE.

More information about the UMB SRE and AVD can be found here https://www.umaryland.edu/cits/services/secure-research-environment-guidebook/. The SRE AVD is the required UMMS/UMB storage platform for TriNetX Research Network data downloads. The data cannot be moved from this environment without UMB and UMMS approval and other required approvals, such as Data Use Agreements from UMB/UMMS and assistance from the RIC team.

1. While your IRB submission is in progress, submit a request through the ICTR Resource Request (link available on the ICTR website in the How to Apply. In the Informatics section of the form, select 'Access to Clinical Data".  Include the IRB protocol and approval letter (if available) in the request. Indicate that the request is for the TriNetX Research Network. The UMMS Epic data honest broker and team will schedule a brief consult with the PI of the IRB, write a specification document, and review the IRB protocol to ensure that the query aligns with IRB approval.
2. The honest broker will submit a download request to TriNetX on behalf of the PI. TriNetX will create the dataset and make the dataset available to the UMMS Epic data honest broker and team who will download the data and move to the SRE AVD environment.

The SRE is a new University virtual environment designed to protect sensitive and restricted research data from misuse and unauthorized access.  UMB faculty researchers can focus on performing research while knowing that the data being used for research purposes are highly secured.  The SRE minimizes risk to the institution and to the principal investigator of an unlawful exposure of sensitive data. 

The SRE is different from the current UMB research computing environment in that the computing resources, data storage and software are not located on a local desktop or laptop computer but are available in a secure Cloud infrastructure.  A faculty researcher simply opens a web browser, connects to their secure research environment, and sees the data and software that they need to perform research analyses.  The data are saved in the Cloud-based infrastructure.  There is no need to use the computing power of a local computer or to store data on a local machine.  It is an analogous user experience to logging in remotely to a desktop computer, where a researcher sees a personalized screen that is familiar to them.

More information about the SRE can be found here https://www.umaryland.edu/cits/services/secure-research-environment-guidebook/ 

TriNetX is compliant with the Health Insurance Portability and Accountability Act (HIPAA), the US federal law which protects the privacy and security of healthcare data. TriNetX is certified to the ISO 27001:2013 standard and maintains an Information Security Management System (ISMS) to ensure the protection of the healthcare data it has access to and to meet the requirements of the HIPAA Security Rule.

Any data displayed on the TriNetX Platform in aggregate form, or any patient level data provided in a data set generated by the TriNetX Platform, only contains de-identified data as per the de-identification standard defined in Section §164.514(a) of the HIPAA Privacy Rule. The process by which the data is de-identified is attested to through a formal determination by a qualified expert as defined in Section §164.514(b)(1) of the HIPAA Privacy Rule. This formal determination by a qualified expert, refreshed in December 2020, supersedes the need for TriNetX’s previous waiver from the Western Institutional Review Board (IRB). Please find more information about the Expert Determination here.

The TriNetX network contains data provided by participating Healthcare Organizations (HCOs), each of which represents and warrants that it has all necessary rights, consents, approvals and authority to provide the data to TriNetX under a Business Associate Agreement (BAA), so long as their name remains anonymous as a data source and their data are utilized for research purposes. The data shared through the TriNetX Platform are attenuated to ensure that they do not include sufficient information to facilitate the determination of which HCO contributed which specific information about a patient.

For UMMS Epic data, the date range is [date] to present. UMMS consists of 13 facilities with varying Epic "go-live" dates. 

• UMMS Epic data is updated monthly in TriNetX
• TriNetX Global Network Research Data - receives data from multiple centers with varying data refresh dates. 

Analytics available within the TriNetX environment include:

• Number of patients in a cohort
• Exploration of that cohort’s demographics, co-morbidities, procedures, medications, and labs.
• Clinical phenotype criteria analysis.
• Rate of arrival prediction.