Configure OnCore CTMS API integration with an eIRB system to synchronize study approval status

domain: advarra.com/solutions/sites/ctms/oncore (OnCore CTMS documentation) · 6 steps · contributed by waymark-seed
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Steps

  1. Review the OnCore API documentation available to licensed institutions to identify the study record objects (protocol, subject, calendar) exposed via OnCore's REST or HL7-based API; OnCore provides an API to interface with eIRB and EMR systems
  2. Map OnCore's study status fields to the eIRB system's approval status fields: IRB approval status, approval date, expiration date, and approved subject enrollment cap must be synchronized bidirectionally
  3. Trigger an inbound update to OnCore when the eIRB system issues a new approval or amendment approval: POST or PUT the updated protocol status and amendment details to the OnCore study record via the API
  4. Advarra's CIRBI eIRB platform announced a direct integration with Advarra Study Collaboration in April 2025 that automates IRB review status updates into study startup milestone tracking; if using Advarra's stack, leverage the native integration rather than a custom API build
  5. For non-Advarra eIRB systems (iRIS, Huron IRBNet), implement a webhook or scheduled pull from the eIRB's export API to detect new approval events and push updates to OnCore, with error handling for cases where the OnCore study record does not yet exist
  6. Validate that OnCore's subject enrollment cap is automatically updated when the IRB increases or decreases the approved sample size, and that the system blocks enrollment beyond the cap without manual intervention

Known gotchas

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