UMB ICTR

Information about TriNetX Access can be found here in the TriNetX Access Management Manual

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 time and review the manual above. 

Who can access TriNetX?

TriNetX accounts were set up for current UMB faculty as of early 2023. Logging in requires a UMID. We are working towards providing access to non-faculty at UMB. If you are faculty and it appears you do not have an account, or if you are non-UMB faculty, please see below.

Requesting a TriNetX Account

• UMMS Epic Data* from 13 facilities (see Date Range of Data tab below for list):
  • 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

• TriNetX Global Network Research Data 

*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. 

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 managaged. 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

Please remember that you will only see de-identified, aggregate data in TriNetX. TriNetX DOES NOT CONTAIN ANY IDENTIFIABLE INFORMATION.  After developing your TriNetX query and examining the aggregate data output, you may then consider using the "Request Data" button. This option notifies the UMMS Epic Team and the UMB ICTR that you are interested in seeing record level data. The UMMS Epic Team will have the key to link your TriNetX query with the UMMS Epic data and will then be able to add variables containing identifiable information to appear in the Epic data pull on the UMMS side. PLEASE NOTE! Before data can be released, you must provided UMB IRB review and approval of all data elements you are requesting. This includes: the purpose; how and where it will be stored; protections; names of individuals who will have access to the data (include them in your IRB team list); how and when it will be stored.  Please used IRB template language below. 

A. REQUESTING UMMS EPIC DATA

1. On the right panel of your TriNetX query portal, select the yellow "Request Dataset" button, which will notify the UMB ICTR and UMMS/UMB Research Informatics Core (RIC) team.  The ICTR will reach out to you about the next steps and application process.  The application link can be found in the "How to Apply for ICTR Resources" section HERE at the bottom of the page. In the application, navigate to the Informatics section and select Access to Clinical Data.

After ICTR administrative review, your application will be forwarded to the UMMS Epic data honest broker and team who will schedule a consult with you to discuss your request. PLEASE NOTE! Data cannot be released without IRB review and approval. The approval must match the project title noted in the ICTR Resource Request form.

Recommended IRB language: 

We will be using the TriNetX Research Network Database, a web-based tool for research population cohort and feasibility queries that provides access to aggregate data of dozens of academic medical centers and health care organizations. The University of Maryland Medical System (UMMS) is part of this network. 

We will perform a search query within the TriNetX portal, designed in consultation with the TriNetX analysts and/or the UMB TriNetX team, using [specify data elements (ICD codes, lab results, etc.)] to identify a cohort of patients meeting the criteria. The information displayed is de-identified aggregate data only. We will send a request to the UMMS Epic data team via the TriNetX "Request Data" feature. This will alert the UMMS Epic data team and the UMB ICTR that we wish to obtain row level data. The UMMS Epic Team will have the key to link our TriNetX query with the UMMS Epic data and will be able to include any identifiable information we need with the Epic data pull at that time.

The dataset will be downloaded as an Excel file in coordination with the UMMS Epic data honest broker and team. The data is downloaded to the University of Maryland Baltimore (UMB) Secure Research Environment (SRE) in the Azure Virtual Desktop (AVD) for our access. The SRE AVD is the required storage platform for UMMS electronic medical record data for research and TriNetX Research Network downloads. The data cannot be moved from this environment without IRB approval and the required approvals, such as Data Use Agreements from the UMB/UMMS campus and with assistance from the RIC team. 

B. REQUESTING TRINETX GLOBAL RESEARCH NETWORK PATIENTS LIMITED DATASET

1. Please note that this activity is outside of UMMS/UMB. Select the 'Browse Network' tab, then select the 'Research' option instead of University of Maryland. Also, TriNetX may charge you a fee for this data.

2. Create study (query) in TriNetX. TriNetX recommends using Summary Statistics and Design Assistance features to analyze criteria and validate your cohort. 

3. Use the yellow 'Request Data' button on far right. TriNetX will contact you to discuss the purpose of the data request and ask about study funding. TriNetX will ask you to include costs for the data in a grant-related request. Costs vary from free, for most non-grant related use, to high, depending on use and grant funding. The investigator must negotiate the costs with TriNetX.  Retain the email from TriNetX that indicates whether or not your study will need to pay TriNetX. If you will need to pay TriNetX, they should provide you with a TriNetX Dataset Order Form with negotiated cost and terms.

4. Seek IRB approval to receive the desired data UMB Institutional Review Board (IRB). Confirm that your query matches what was approved by the IRB or submit an IRB modification to update your protocol to indicate use of the TriNetX Research Network as the data source. 

Suggested IRB language:

We will be using the TriNetX Global Research Network Database, a web-based tool for research population cohort and feasibility queries that provides access to clinical data of dozens of academic medical centers and health care organizations. The University of Maryland Medical System (UMMS) is part of this network. 

We will perform a search query within the TriNetX portal, designed in consultation with the TriNetX analysts using [specify data elements (ICD codes, lab results, etc.)] to identify a cohort of patients meeting the criteria. The output is deidentified aggregate data only. To obtain a limited dataset, we will request the data from TriNetX who will follow up with the PI of this protocol to discuss the purpose of the data request. If approved, the UMMS/UMB Research Informatics Core (RIC) honest broker will work with TriNetX to move the limited dataset from TriNetX to the UMB Secure Research Environment (SRE) Azure Virtual Desktop (AVD) for our access. The SRE AVD is the required storage platform for TriNetX Research Network data downloads. The data cannot be moved from this environment without IRB approval and other required approvals, such as Data Use Agreements from the UMB/UMMS campus, and with assistance from the RIC team. 

5. Once your IRB protocol is approved, submit a request through the ICTR Resource Request form HERE. Scroll to the Informatics section of the form and select 'Access to Clinical Data".  Include the IRB protocol and approval letter for your protocol in the request, and indicate that you are approved to receive data from the TriNetX Global Research Network. The UMMS Epic data honest broker and team will schedule a brief consult with the PI, write a specification document, and review the IRB protocol to ensure that the query aligns with IRB approval.

6. 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.

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.