Summarize with:
An electronic IRB system manages a human subjects protocol from start to finish: submission, pre-review, committee action, amendments, continuing review and closure, in a workflow staff can track and report on. Most Institutional Review Board (IRB) offices already run some version of one. The real question is whether your current setup, whether paper and email or an older eIRB platform, still keeps pace with your review volume and reporting load. This guide covers how to tell, what the system should handle at each stage, and how to move without disrupting active protocols.
Key takeaways
- An outdated IRB process shows up first as slow answers to simple questions: where a submission is, what expires next month, and how long review is taking.
- The 2018 Common Rule revisions made review requirements more conditional, so tracking each study's status now matters more than it used to.
- An electronic IRB system should route, remind, version and report at every stage. Determinations stay with the IRB.
- A safe transition depends on decisions made before go-live: what legacy data moves, how forms change, and how long the parallel period runs.
How Do You Know Your IRB Process Has Reached Its Limit?
Offices still working from paper, email and shared drives usually feel the strain in the same places. Status questions from investigators get answered by searching inboxes. Completeness checks rely on whichever coordinator remembers what a full board submission needs. Agendas are assembled by hand the week of the meeting, and continuing review dates sit in a spreadsheet that one person maintains.
Offices on an older electronic system feel it differently:
- Reports leave the system. Turnaround and volume figures are exported and rebuilt in spreadsheets before leadership sees them.
- Every change waits on the vendor. A new form question or a routing change needs a support ticket, so policy updates lag behind the policy. Without IRB workflow automation, every policy change becomes a manual workaround.
- Related reviews run outside it. Conflict of interest disclosures, reliance agreements and ancillary sign-offs are tracked separately, so nobody has a full picture of a study's readiness.
- Principal investigators (PIs) cannot see progress. Status calls and emails take up coordinator time that should go to pre-review.
Each of these costs something beyond inconvenience. Review timelines stretch, staff time goes to clerical work rather than regulatory judgment, and the institution has less visibility into its own human research protection program (HRPP). If workload is growing faster than staffing, these gaps widen every cycle.
How IRB Workload Has Changed Since the 2018 Common Rule Revisions
The revised Common Rule 45 CFR 46 , the "2018 Requirements") removed some work and added new tracking obligations in its place.
Continuing review became conditional. Under 45 CFR 46.109(f), continuing review is generally no longer required for studies eligible for expedited review, studies approved through limited IRB review, or studies that have moved into data analysis or follow-up clinical data only. The IRB can still require it, but must document why (45 CFR 46.115(a)(3)). FDA-regulated studies remain under 21 CFR 56, which still requires continuing review at least once a year (21 CFR 56.109(f)). One office can now hold protocols on different review schedules, determined study by study.
Limited IRB review was introduced for certain exempt categories involving identifiable information. These are exempt studies that still need an IRB action, and they have to be tracked as such.
Single IRB review became the default for cooperative research. For most federally funded multi-site research in the United States, 45 CFR 46.114(b) requires reliance on one IRB of record, and the NIH single IRB policy covers NIH-funded multi-site studies. Your office may act as the reviewing IRB for some studies and the relying institution for others. As the relying institution, you still handle local context review, ancillary reviews and institutional sign-off.
The net effect is more conditional logic per study. A process that depends on someone remembering which rule applies to which protocol becomes harder to defend at audit and harder to run at volume.
What Should an IRB System Handle at Each Review Stage?
Use the stages below as an evaluation framework, whether you are buying a first system or replacing one.
Intake and completeness check
Good IRB submission software uses smart forms that show only the questions that apply to the study type and flag missing attachments before the submission reaches the office. Coordinators should spend pre-review on substance, not on chasing a consent form.
Review-level routing
Once IRB staff or the chair determine whether a study is exempt, expedited or full board, the system should route it down the matching path. IRB review automation handles the routing. The determination stays with the IRB.
Reviewer assignment
Staff should be able to assign primary and secondary reviewers, see current reviewer workload, and record reviewer conflict of interest declarations alongside the assignment.
Meetings, agendas and minutes
Full board items should flow onto a meeting agenda. Minutes should capture each determination, vote and required modification in the format your regulations require, ready for staff review and approval.
Amendments, continuing review and reportable events
The system should version every document, distinguish minor from significant amendments for routing, issue reminders ahead of expiration or check-in dates, and take in deviations and unanticipated problems through a defined intake.
Reporting
Turnaround by stage, volume by review level, items due in the next 60 days, and open reportable events should all be available without an export.
How Do You Switch IRB Systems Without Disrupting Active Protocols?
Switching IRB systems safely comes down to seven steps: map the current workflow, rebuild forms, scope legacy data, configure routing, pilot one review type, train each audience, and run a defined parallel period.
- Map how review actually runs today. Document the real workflow, including the informal workarounds. Configuring a new system to an idealized process recreates the old problems in new software.
- Rebuild forms around review decisions. Don't copy paper forms field for field. Structure questions so the answers drive routing and pre-review.
- Decide what legacy data moves. Active protocols need their approval dates, expiration or check-in dates, current approved documents and consent versions. Closed studies may only need archiving, provided you meet the retention requirement in 45 CFR 46.115(b), at least three years after completion. Settle this scope early. It drives the timeline more than any other decision.
- Configure routing and notifications to your own policies. Reminder intervals, escalation contacts and ancillary review triggers should reflect your institution's standard operating procedures.
- Pilot one review type. Exempt or expedited submissions are a lower-risk starting point than full board review.
- Train each audience separately. Coordinators, committee members and PIs need different training. PIs need the least, and their first experience shapes adoption.
- Run a defined parallel period, then cut over. Set an end date for accepting submissions the old way, and communicate it well in advance.
Timing matters too. Avoid a go-live in the months before an AAHRPP (Association for the Accreditation of Human Research Protection Programs) site visit or during your heaviest submission season.
Before and After: What Changes for Staff, Reviewers and PIs
What to Measure in the First Two Review Cycles
Capture a baseline from your current process before go-live. Then track:
- Days from submission to completed pre-review
- Share of submissions returned to the PI as incomplete
- Total turnaround by review level: exempt, expedited and full board
- Continuing reviews and check-ins completed before expiration
- Reviewer turnaround from assignment to comments
- Volume of PI support requests to the office
Early results reflect configuration as much as the system itself. If a number moves the wrong way, check the form logic and routing rules before drawing conclusions.
Where Key Solutions Fits
The Human Subjects (IRB) module in eProtocol by Key Solutions supports IRB offices through the review stages described above, from submission through continuing review.
The system supports the process. The principal investigator remains responsible for the protocol, and the institution remains responsible for oversight of its human research protection program.
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If you are weighing a move from paper or an older platform, Request a Demo. We start with a short conversation about how your review process runs today, then show a walkthrough built around your environment.
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