Compliance module
IRB software for human research protection offices
Electronic protocol submission, committee review, amendments and continuing review, on the same record as the proposals and awards that fund the study.
The failure this replaces
The protocol was approved. Nobody noticed the approval expired.
Almost every institution can submit a protocol. Far fewer can tell you, without a search, which currently funded studies are running on an approval that lapsed, or on a protocol whose amendment was approved but never filed against the award.
That gap is a tracking problem, so a better submission form doesn't close it. Versions, amendments, renewals and expirations have to live on the same record as the study, and the study has to be linked to the money.
What it does
Submission, review, and the years afterwards
Protocol submission
The investigator builds an electronic protocol application designed around the federally mandated criteria for human research participants and submits it to the Human Research Protections Office. There is no parallel Word document and no emailed attachment somebody has to file.
Committee review
The protocol routes to the IRB and its committee members inside the system. Reviewers see what is assigned to them, and the office sees where every protocol is sitting without asking anyone.
Amendments and versions
The document tracks versions and amendments against the original protocol, so the approved version and the change history are one record instead of two folders that disagree.
Continuing review and expirations
The system tracks renewals and impending expirations. It knows a protocol is expiring before the coordinator does, which is the difference between a renewal and a lapse.
Linked to the funding it belongs to
The Streams function links a protocol to the proposals, institutional proposals and awards it belongs to. When a sponsor asks whether the approval covers the funded work, that is a lookup.
Training data from where it already lives
Streamlyne's integrations import relevant data from your own systems, such as CITI or other training records held in the LMS or data warehouse, so a reviewer checks a completion status instead of chasing a certificate.
The product itself
What the screens look like
Protocol submission
Committee review
Amendments and versions
Protocol history
Why it is not a separate purchase
A protocol is about a study somebody is funding
If the protocol lives in an IRB product and the award lives in your eRA system, somebody reconciles the two by hand, and they do it at the moment a sponsor or an auditor asks, which is the worst possible moment to discover a mismatch.
In Streamlyne, IRB is one of twelve modules in a single codebase, and the Streams function links a protocol to the proposals, institutional proposals and awards it belongs to. IACUC and IBC sit on the same committee machinery, so the second and third compliance areas you bring in are configuration, with no new system to learn.
- IRBHuman-subjects protocols, amendments, continuing review
- IACUCSpecies, procedures and protocol exceptions for animal care
- IBCBiosafety, on the same committee machinery
- COIFinancial disclosure, assigned per project
- Export controlActivity tracking wired into Negotiations
Questions
What the IRB office and procurement both ask
What is IRB software?
The system an institution uses to run human subjects review. The investigator builds and submits the protocol application, the Human Research Protections Office and the Institutional Review Board review it, and the record holds the determination, the amendments, the continuing review and the expiration date. The question it has to answer without a search is whether approval for this study is current right now and covers what is being done.
Does it handle amendments and continuing review, or only the first submission?
Both. The second is where paper processes usually fail. The protocol document tracks versions, amendments, renewals and impending expirations on the same record, so the approved protocol and its change history can't drift apart. First submissions get attention. A continuing review that didn't happen is the one that costs you.
Can the IRB module run on its own, or do we need the whole suite?
It can run on its own, and institutions commonly start with whichever module is costing them the most time. Because Streamlyne is a single codebase, adding another module later is configuration work, with no second implementation. That is the practical difference between a suite and a set of products bought separately.
How does IRB relate to IACUC and IBC?
They share the same submission, review and committee machinery. IACUC adds species, procedures and protocol-exception sections for animal care and use. IBC is the same shape for biosafety. A coordinator who has learned one already knows where things are in the next, and all three link to proposals, institutional proposals and awards through the same Streams function.
Can protocols be linked to the awards they support?
Yes. That is what the Streams function is for. A protocol links to the proposals, institutional proposals and awards it belongs to, so the compliance record and the funding record are connected instead of reconciled by hand at audit time.
Does the IRB module use the modern interface or the classic one?
The compliance modules run in the classic Streamlyne interface today, and we would rather say so here than have you discover it in a demo. You get the full protocol lifecycle on the same records as the rest of your research administration. You don't get the newer UI that pre-award has. If a modern compliance interface is a hard requirement, ask us where that sits before you evaluate anything else.