VCU TriNetX Request Deidentified Dataset Guide

There are FOUR steps to the TriNetX Deidentified Dataset Download request process. The Wright Center informatics team is responsible for providing dataset downloads following the institutional process below. It is the responsibility of the Principal Investigator (PI) / study team to follow this process and provide all information to ensure a timely request response.

STEP 1:  Submit Request at https://informatics.vcu.edu

STEP 2:  Request dataset in the TriNetX system

STEP 3:  Honest Broker Quality Control Approval

STEP 4:  Download data

STEP 1: Submit Request at https://informatics.vcu.edu

To request a deIdentified dataset from the TriNetX VCU or Research Network (multiple institutions), a VCU Wright Center informatics request form must be submitted for each protocol.

Submit the request at:  https://informatics.vcu.edu

1) Go to Form

2) Choose Google Mail. Log in with your eID vcu email (@vcu.edu email) 

If you do not have a VCU email and eID, please contact informatics@vcu.edu and ask for help creating an account using your @vcuhealth.org account.

3) Click on Research Support

4) Complete the Research Support request form. Include the following items in the request form:

a) Add "TriNetX Extract" to the request description

b) Attach the following items (required) in the upload document space:

1. IRB SmartForm application (IRB_Application_HM#######_yyyymmdd.docx)
2. Not Human Subjects Research (NHSR) protocol (Protocol_HM#######_yyyymmdd.pdf)
3. IRB Application Approval Letter (IRB_Approval_HM#######_yyyymmdd.pdf)

5) A Wright Center informatics analyst will review the request confirming IRB approval for the use of a downloaded deidentified data set and will contact the requester for additional information as needed. 

6) Sign PI Assurance Form 

1. The PI Assurance form will be sent via a REDCap survey to the PI for signature from the informatics analyst.
2. The signed assurance document will be attached to the informatics request.

STEP 2:  Request dataset in the TriNetX system

Within the TriNetX platform, go to the TriNetX query corresponding to the requested deidentified data set download request. Be certain your query has been assigned a name, click the star, and click “Request Dataset” for your query/queries of interest.

STEP 3:  Honest Broker Quality Control Approval

Requesting a dataset download notifies the Wright Center informatics analyst to confirm the queries with the PI and present the queries at the next Honest Broker Quality Control meeting for approval. Note: Queries exceeding 100,000 patients cannot be approved or processed.

• If the dataset request is for the “Virginia Commonwealth University” Network, the study creator will be notified after dataset approval.
• 1 business day to process after approval
• If the dataset request is for the “Research” Network, the TriNetX vendor will ask if your study has no funding, the protocol title, the purpose of use for the dataset, PI contact, and sign off on the forms before being processed.
• 1 week - 2 weeks to process after approval

STEP 4: Download data

After Honest Broker approval, the requested dataset becomes available in the TriNetX system, where it can be downloaded from the left-menu “Available Datasets”, then “Download Dataset”.

Example IRB Language

Provide a full description of the project: This is a review of the de-identified database TriNetX. This project is designed to answer the question of whether ... The full dataset will be requested to perform .... The data will be downloaded directly from the TriNetX website. Only de-identified data from the TriNetX research network will be used in the study and does not require a reference to the Enterprise Data Warehouse protocol.

Explain why you think this project does not meet the following regulatory definition of research: Research: a systematic investigation designed to develop or contribute to generalizable knowledge. This project does not provide systematic investigation, but performs a review of already collected and properly de-identified datasets from TriNetX.