IRB management software that keeps approval periods, pathways and minutes in one record
IRB management is the administration of human subjects research review: intake, pre review, assignment to a review pathway, convened meetings, determinations, approval periods and record retention. An IRB must have at least five members, registration with OHRP is effective for 3 years and must be renewed every 3 years, and records must be kept for at least 3 years after research is completed under 45 CFR 46.115. Neurobird holds the review record itself, so a determination and its minute entry are the same object rather than two pieces of work.
Neurobird IRB Management in short
- Take submissions in a structured form rather than as an email thread with attachments
- Route by review pathway: exempt determination, expedited review or the convened board
- Track approval periods and continuing review dates so an expiry is a scheduled event, not a discovery
- 46.107 Each IRB must have at least five members with varying backgrounds, including at least one member whose primary concerns are nonscientific, and quorum rules apply at every convened meeting. eCFR, 45 CFR 46
- 3 years IRB registration is effective for 3 years and must be renewed every 3 years, with contact and chair changes updated within 90 days under 45 CFR 46.505. eCFR, 45 CFR 46 subpart E
- Pricing runs 290 to 1100 US dollars per month across 3 tiers. Early access is free.
What IRB offices and human research protection programs actually deal with
Why it stays broken
The regulation is procedural and the office runs on email. 45 CFR 46 sets pathways, quorum, approval periods and retention, and the tooling in most offices is a shared mailbox plus a tracking spreadsheet. So the determination is made properly and then recorded twice, badly.
An approval that lapses by 1 day is a reportable event, not an administrative slip.
Protocols requiring Full Board review must be submitted in Kuali at least 10 business days before the current month’s meeting to be reviewed at that month’s meeting.
Neurobird IRB Management Document Automation Platform
Make the determination the record. Pathway, criteria, vote and expiry captured once, then the minutes and the tracking are outputs rather than separate work.
- 1Take submissions in a structured form rather than as an email thread with attachments
- 2Route by review pathway: exempt determination, expedited review or the convened board
- 3Track approval periods and continuing review dates so an expiry is a scheduled event, not a discovery
- 4Produce minutes that show attendance, quorum, the vote and the controverted issues without retyping
What changes with Neurobird IRB Management?
The same work, read left to right: how it runs today, and how it runs once the record is in one place.
| Today | With Neurobird IRB Management |
|---|---|
| The submission arrives as email attachments and becomes an agenda item by hand, one protocol at a time | Take submissions in a structured form rather than as an email thread with attachments |
| Continuing review dates are tracked in a spreadsheet, and an expired approval is a lapse that has to be reported rather than fixed quietly | Route by review pathway: exempt determination, expedited review or the convened board |
| Minutes have to show the vote, the quorum and the reasoning, and they get written from memory the week after the meeting | Track approval periods and continuing review dates so an expiry is a scheduled event, not a discovery |
Who is this for?
Same regulation, three different sizes of office.
One board, one administrator
You are the office. You need the calendar and the minutes to come out of the work you already do, not to be a second job.
Several boards, mixed portfolios
Common Rule and FDA regulated studies sit side by side. You need one record that maps to both without keeping two.
You review for other institutions
Reliance agreements are the product. You need who relies on whom, for what, and until when to be a fact rather than an email search.
The review queue, as an administrator would work it
A working preview. Tick an item to file it into the review record.
Watch the fields extract from the document.
What the Common Rule actually requires of an IRB office
Useful if you are writing SOPs or preparing for an OHRP or FDA inspection. Each source links out.
Each IRB must have at least five members with varying backgrounds, including at least one member whose primary concerns are nonscientific, and quorum rules apply at every convened meeting.
eCFR, 45 CFR 46IRB registration is effective for 3 years and must be renewed every 3 years, with contact and chair changes updated within 90 days under 45 CFR 46.505.
eCFR, 45 CFR 46 subpart EContinuing review of research requiring convened review must occur at intervals appropriate to risk and not less than once per year, except for the categories listed in 45 CFR 46.109(f).
eCFR, 45 CFR 46The revised Common Rule was published on January 19, 2017, with a general compliance date of January 21, 2019 and January 20, 2020 for the cooperative research provision.
Federal Register, Federal Policy for the Protection of Human SubjectsFDA regulated research is reviewed under a parallel IRB regulation, so many boards operate under both frameworks at once for the same protocol.
eCFR, 21 CFR 56How does Neurobird IRB Management work?
Intake with a shape
Submissions arrive as structured records with the documents attached, so pre review starts with a checklist rather than a download.
Route by pathway
Exempt determination, expedited review or convened board. The criteria under 45 CFR 46.104 and 46.110 sit next to the decision, and the reason is captured.
Minutes and expiries as outputs
Attendance, quorum, votes and controverted issues assemble from the meeting record, and approval periods drive the calendar instead of a spreadsheet.
Irb management software questions, answered
Key terms
- What does IRB management involve?
- IRB management is the administration of human subjects research review: intake, pre review, assignment to a review pathway, board meetings, determinations, approval periods and record retention. The office is also responsible for registration with OHRP and for the records that show the board met the requirements of 45 CFR 46.
- What is the single IRB requirement?
- For cooperative research conducted in the United States, institutions must rely on approval by a single IRB for the portion of the research conducted here. The compliance date for that provision of the 2018 Requirements was January 20, 2020, and reliance agreements became a standing part of the office workload.
How often must an IRB register and renew?
Under 45 CFR 46 subpart E, IRB registration becomes effective when reviewed and accepted by OHRP and is effective for 3 years, and each IRB must renew its registration every 3 years. Contact person and chair changes must be updated within 90 days.
Is continuing review still required for every study?
No. Under the 2018 Requirements the convened IRB must conduct continuing review at intervals appropriate to risk and not less than once per year, but 45 CFR 46.109(f) removes the requirement for certain categories, including research eligible for expedited review. The office still has to record which determination was made and why.
Does this replace our electronic submission system?
If you have one, no. It handles the review record: pathway, determinations, approval periods, minutes and retention. Submissions can arrive from wherever they arrive now.
Why we are building this
IRB work is careful, procedural and consequential. The determination is a judgement about risk to people, and the record of it is often a spreadsheet cell and a paragraph typed a week later.
The 2018 Requirements made the pathways more sensible and made the record keeping matter more, not less. Offices absorbed that with the tools they already had.
We would rather build this with IRB administrators than for them. Tell us how your review record works, and where we have got it wrong.
Where the requirement comes from
The regulations that define review pathways, membership and records.
- eCFR, 45 CFR 46 protection of human subjects Membership, review pathways, continuing review, minutes and record retention requirements.
- eCFR, 45 CFR 46 subpart E, IRB registration When an IRB must register, how registration is filed and the 3 year renewal cycle.
- eCFR, 21 CFR 56 institutional review boards The FDA parallel to the Common Rule, which applies to regulated products research.
- Federal Register, Federal Policy for the Protection of Human Subjects The 2017 publication of the revised Common Rule, including compliance dates.
How much does Neurobird IRB Management cost?
Priced per board because review capacity is per board. Protocols, members and documents are unlimited on every tier.
- Structured intake
- Pathway routing
- Approval period tracking
- Determination log
- Email support
- Everything in Single board
- Minutes assembly
- Continuing review calendar
- Reportable events register
- Named contact
- Everything in Research office
- Reliance agreement tracking
- FDA and Common Rule dual mapping
- Inspection evidence pack
- Onboarding included
Get free early access
If you administer an IRB, tell us how approval periods and minutes are tracked today and what usually slips.
Straight answer on where this is: In development. Early access gets the working preview, influence on what ships first, and early access pricing. It does not get you a login today.
Prefer email? Write to office@neurobird.com and a person will reply. No autoresponder.