Protocol Amendment and Continuing Review Built Around the Date on the Approval Letter
Kissflow tracks every IRB-approved protocol's continuing review date and any pending amendment against that date, flags the ones approaching a lapse, and escalates them before approval expires mid-study.
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The date is on the approval letter. The reminder is not.
The letter approving a protocol also sets the date it stops being approved, and that date does not send its own reminder. A continuing review is due before the approval anniversary, not after, and an amendment filed to change a data collection procedure or add a study site does not modify the original approval until IRB action clears it. Between those two clocks, a lot of active research runs closer to a lapse than the principal investigator realizes.
Most IRB offices track this on a spreadsheet keyed to approval dates, updated when someone remembers to check it. An amendment sits in an inbox next to a dozen others with no severity ranking. A continuing review sixty days out looks the same as one due next week until someone happens to sort by date.
Kissflow tracks every protocol's continuing review date and every open amendment as a monitored record, not a static file. Protocols approaching their review window get flagged automatically, amendments route for the level of review they actually require, and anything drifting toward a lapse escalates to the IRB chair before the study's approval status becomes a problem. Your existing IRB submission system stays the system of record for the protocol file itself; Kissflow is the layer that makes sure nothing on it goes quiet.
What a spreadsheet of approval dates misses
Amendments and continuing review share no severity ranking
A minor personnel change and a new data collection procedure land in the same inbox, reviewed in the order they arrived.
The reminder depends on someone checking the date
A continuing review due in sixty days looks identical to one due next week until someone sorts the spreadsheet.
A lapsed approval is discovered, not prevented
Research continues past its review date because nobody flagged the window closing until it already had.
No trend view across the active protocol portfolio
The IRB office cannot see, at a glance, how many protocols are approaching review in the next quarter.
Six modules. Built around the date on the approval letter, not a spreadsheet someone maintains.
Every module ships with default forms, thresholds, and dashboards. Configure each one to your IRB's review calendar.
Amendment intake
A change to an approved protocol, procedure, personnel, or site, is logged against the original approval it modifies.
Continuing review calendar
Every active protocol's review window is tracked against its actual approval anniversary, not a generic annual cycle.
Threshold-based alerts
Protocols approaching their review window or an unresolved amendment trigger an alert before the deadline, not after.
Escalation workflow
A protocol drifting toward a lapse escalates to the IRB chair with the specific deadline it is at risk of missing.
Corrective action
A lapsed or at-risk protocol gets a documented remediation step and a record of when it was resolved.
Portfolio trend dashboard
The IRB office sees every active protocol's review status across the portfolio, not one file at a time.
From request to system of record in four steps
Capture
An approved protocol enters the register with its continuing review anniversary attached.
Validate
A proposed change is logged and linked to the protocol it modifies, pending IRB action.
Track
Protocols nearing their review window or sitting with an open amendment surface automatically through threshold alerts.
Report
The register is the live system of record for every protocol's status, and anything drifting toward a lapse escalates to the IRB chair before the approval window closes.
What changes when protocol oversight runs on Kissflow
| Process | Before Kissflow | On Kissflow |
|---|---|---|
| Review calendar | Tracked on a spreadsheet someone updates manually | Tracked automatically against each protocol's actual approval date |
| Amendment intake | Lands in an inbox with no severity ranking | Logged and linked to the original approval it modifies |
| Deadline visibility | A review looks urgent only once someone sorts by date | Flagged automatically as the window approaches |
| Lapse prevention | Discovered after the approval has already lapsed | Escalated to the IRB chair before the deadline passes |
| Portfolio view | One file at a time | A trend dashboard across every active protocol |
| Corrective action | Undocumented, handled case by case | Logged with a remediation step and a closure record |
Connects to your IRB submission system; it stays the system of record
Kissflow does not replace your IRB submission platform or the protocol file it holds. It is the monitoring layer that tracks every protocol's amendment and continuing review status against its actual deadlines.
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Built around the date on the approval letter
Live in weeks
Forms, routing, and dashboards are configured in the visual builder, and the AI Builder can generate a starting workflow from a description of your IRB's review process.
Deadlines tied to the real approval date
Each protocol's continuing review window is calculated from its own anniversary, not a shared institutional date.
Escalation before the lapse, not after
An at-risk protocol reaches the IRB chair while there is still time to act.
A portfolio view, not a spreadsheet
Every active protocol's status is visible on one dashboard.
Role-based access
Investigators see their own protocols; the IRB office sees the full portfolio.
An audit trail for every action
Amendment review, continuing review, and escalation history stay attached to the protocol record.
Related apps
Adverse Event Reporting & Escalation Management System
Handles unplanned safety incidents on an active protocol; see the FAQ for how the two apps divide the work.
Research Compliance Orchestration (IRB/Ethics/Export Control)
The broader cross-office hub for a sponsored award touching IRB, ethics, and export control at once.
Research Audit Preparation & Evidence Assembly Management System
Where the amendment and continuing review history in this app feeds a broader research audit readiness record.
We help IRB offices catch a protocol drifting toward a lapse while there is still time to act.
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Talk to usGot questions? We're here to help.
Get SupportNo. Your IRB submission platform remains the system of record for the protocol file. Kissflow tracks the continuing review deadline and any open amendment against that file, and escalates the ones at risk.
Adverse Event Reporting & Escalation handles an unplanned safety incident on an active study, reported as it happens. This app tracks the routine, dated obligations of an approved protocol, amendments to what was approved and the continuing review that keeps the approval valid, neither of which is triggered by an incident.
Research Compliance Orchestration is the broader coordination hub for a sponsored award that touches IRB, ethics, and export control across multiple offices. This app is scoped to one function within that picture, keeping an approved protocol's amendment and continuing review status current.
Any change to what the IRB originally approved, a new data collection procedure, an added study site, a personnel change, or a revised consent process, gets logged against the protocol it modifies.
Yes. Review windows, escalation rules, and dashboards are configured in the visual builder, and the AI Builder can generate a starting workflow from a description of your review process.
It escalates to the IRB chair with the specific deadline it is at risk of missing, in time to act before approval status becomes a problem.
Configuration and AI-assisted setup typically move initial rollout to weeks, not a multi-month systems project.
Kissflow is certified to SOC 1, SOC 2, SOC 3, and ISO/IEC 27001, supports HECVAT review, and is built to support FERPA and GLBA Safeguards obligations, with data residency options in the US, EU, APAC, and Oceania.
