ENACT Network Governance and Regulatory Information

Review these resources for an overview of ENACT governance documentation. These resources are not intended to serve as an exhaustive account of network policies and procedures. Please reference the ENACT Governance Document for more detailed information.

ENACT Governance Structure

The ENACT governance structure includes required reporting to the National Center for Advancing Translational Sciences (NCATS) through the ENACT PI Group, which is made up of the four PIs listed on the NCATS grant (Steven Reis, University of Pittsburgh; Gary Firestein, UCSD; Robert Toto, UTSW; Shyam Visweswaran, University of Pittsburgh). The ENACT Executive Committee reports to the ENACT PI Group and provides oversight for the project. Reporting to the ENACT Executive Committee are five work groups, as outlined in the figure below. Information in the HIPAA & IRB, ENACT Terms of Query Access, and ENACT Site Responsibilities tabs are in the process of being updated. Documentation linked to these tabs are current as of May 31st, 2021 (the end of the ACT grant). Updated documentation will be shared as it is available.
Figure outlining the five ENACT Work Groups and the reporting structure of ENACT
The ENACT Network only shares aggregate patient counts, and never shares (or accesses) patient-level data. Each site monitors and reports on local usage of the ENACT Network to ensure compliance with the ENACT Data Use Agreement.
Link to ENACT Terms of Query Access (DUA)
Part of the ENACT implementation process at each site involves applying for approval from the site’s IRB. No additional study-specific IRB approval is needed for investigators using ENACT.
Each ENACT user must agree to the Terms of Query Access before gaining access to the ENACT tool. The terms of access ensure that only approved users are accessing the network and using it for its intended purpose. Each site manages this approval process differently. To read the terms in their entirety, please find the 
Terms of Query Access here.

Each ENACT site is expected to adhere to the following:


  • Stay current on software versioning as guided by ENACT Network Operations
  • Ensure integrity of data use by regularly monitoring local query activity
  • Adhere to expected uptime policies and work through issues in a timely manner
  • Refresh data on at least a monthly basis


The decision to participate in any study using ENACT is at the discretion of the ENACT Network site. There is no obligation for a site to participate in a study proposed by another ENACT site.


ENACT governance also outlines three standard operating procedures for ENACT sites, listed below.

SOP 1: Adding New or Modifying Existing Data Domains. The Data Harmonization work group defined a set of data domains (e.g. demographics, diagnoses, procedures) and standards for representing data in these domains. As ENACT continues to evolve, there is the need to modify current domains and add new domains. This SOP lists the process required to suggest additions and modifications to the ENACT data domains. 


SOP 2: Process for User Registration and Management. This SOP ensures that the ENACT Network is accessed only by individuals authorized by a participating ENACT site. User registration and management is handled locally at each ENACT site.


SOP 3: Monitoring and Auditing. To ensure ENACT achieves its goals and participating sites operate in accordance with ENACT governance, query activity will be periodically audited by local site Data Stewards. Only authorized individuals will have access to information that can identify the user. Network usage metrics will also be collected on a regular basis, but will not include user identifying information.

For more information, please reference the 
ENACT Governance Document
. If you have further questions, you may reach out to your Site Operations Coordinator and Data Steward.

Publications based on research using the ENACT Network must cite the NCATS ENACT grant: "This project was supported by the National Institutes of Health through grant 1U24TR004111-01." Publications should also cite the appropriate CTSA Hub grant numbers from participating institutions.


Any Intellectual Property derived from use of the ENACT Network must cite the NCATS ENACT grant: "This project was supported by the National Institutes of Health through grant 1U24TR004111-01."


Publications in which data source partners (hospitals) are to be identified by name will be reviewed for use of name only by each identified hospital prior to submission of a manuscript. At no time will specific participating data source partners be named unless explicitly approved by the data partner. Such approval must be requested and received in writing between the requestor and the Senior Vice President of Research, the Chief Information Officer, or their respective designee. Any entity (e.g., hospital) that does not agree to be identified by name as a data source will be instead identified as a “CTSA-affiliated hospital.”