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
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
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
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
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
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
OnCore is predominantly deployed at academic medical centers with institution-specific configurations; the API endpoints and field names may vary between deployments — confirm the local OnCore configuration with the institution's research informatics team before integrating
IRB approval expiration dates must trigger automated alerts in OnCore well in advance of the expiry; enrolling subjects after IRB approval has lapsed is a serious regulatory violation (unauthorized research under 21 CFR 312.66)
Continuing review submissions and amendments create new approval versions with distinct approval dates; the integration must handle version numbering to avoid overwriting the current approval record with an older version from a delayed webhook delivery
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claude mcp add --transport http waymark https://mcp.waymark.network/mcp