The Regulatory workspace manages the formal package around your study: submissions to an IRB or IEC (an Institutional Review Board or Independent Ethics Committee — the body that must approve research involving people before it starts), amendments to an approved protocol, and safety events that need regulatory attention. It also enforces the rule those bodies care about most: a study that requires ethics approval does not enroll anyone without a current one.
The workspace is fed by configuration you already entered in the Study Builder, so regulatory work builds on the protocol rather than restating it.
The four tabs#
| Tab | What it does |
|---|---|
| Overview | The current regulatory status at a glance: whether enrollment is allowed or held, the current approval with the protocol and consent versions it covers, and counts of open amendments, continuing reviews, and reportable events. |
| Submissions | Manage the review bodies the study submits to, build IRB/IEC submission packets, and record the resulting approvals. |
| Amendments | Open and track protocol and submission changes against the current approval. |
| Reportable events | Safety events that require regulatory attention, surfaced from the safety workflow with their category, deadline, and reporting status. |
Depending on your study, the workspace may also show a Registrations tab for public trial-registration records.
The activation gate#
When a study is under IRB oversight in the platform, enrollment is gated on approval. Without a current approval covering the in-use protocol and consent versions, the Overview tab shows Enrollment held: new enrollment and randomization are paused until the blocking items are resolved. Once a current approval covers what participants actually see, the status flips to Enrollment allowed.
Approvals are version-bound — an approval is recorded against specific protocol and consent versions, not the study in the abstract. That has two practical consequences:
- Amending the protocol means the amended version needs approval before it applies. Opening an amendment records the changed areas, the new protocol version, and a change summary, and routes it to a review body.
- An amendment that changes consent flags itself: enrolled participants will need to re-consent when the amendment is approved.
Oversight is per study
Submissions and packets#
On the Submissions tab you first register the review bodies your study answers to — a central, local, or institutional IRB, or an EU ethics committee, each with its jurisdiction. Decisions can be recorded manually, or through a connector to the review body where one is available.
Starting a submission snapshots the current protocol and consent versions onto it, so what was submitted is fixed even as drafting continues elsewhere. The packet itself is largely generated, not transcribed: the platform renders IRB-ready documents — protocol document and summary, consent document, data-management plan, safety plan, randomization procedures, recruitment material — from the structured study configuration it already holds. Documents the platform cannot author, such as investigator CVs, conflict-of-interest disclosures, and the IRB application form itself, have typed upload slots.
Fix it in the Builder, not the packet
What feeds this workspace#
Two Study Builder sections supply most of the regulatory workspace's raw material:
- Safety & Consent holds the participant-facing consent content and the central IRB / ethics details — IRB name, protocol number, approval status and dates, and any sIRB reliance agreement — plus the adverse event and SAE definitions and safety oversight information. See Consent and ethics setup.
- Regulatory profile sets the reporting regime: the regulatory type, IND or IDE numbers where they apply, the investigator-to-sponsor reporting window, and red-flag rules. These settings drive the safety and reporting workflows that generate reportable events. See Safety operations.
Reportable events close the loop: when the safety workflow determines an event meets the regulatory reporting bar, it appears on the Reportable events tab with its deadline, and you mark it reported once the IRB has it.