Tier I
Tier I — AI Training
- Kickoff meeting1 hour to outline training needs.
- Stakeholder training1.5 hours with an AI expert plus Q&A, recorded and transcribed. Unlimited attendees.
- Presentation slides1 customized slide deck.
- Closeout meeting1 meeting 2 weeks post-training for Q&A.
Tier II
Tier II — AI Training
- Kickoff meeting1 hour to outline training needs.
- Stakeholder training1.5 hours (basics) plus 1 hour advanced training for IRB chairs or compliance staff. Recorded and transcribed.
- Presentation slides2 customized slide decks.
- Checklists & templates1 AI checklist tailored to your needs.
- Closeout meeting1 meeting 2 weeks post-training for Q&A.
Start-up
Start-up — IACUC Startup Kit
- Kickoff meeting1 hour to outline plans for an IACUC at your organization.
- Stakeholder training2 training sessions for IACUC members and researchers.
- Presentation slides1 customized presentation.
- Checklists & templatesCharter template, appointment-letter templates, reviewer checklist, 2 SOP templates and an SOP development guideline.
- Closeout meeting1 meeting 2 weeks after training for Q&A.
IRB Review
IRB Review — Student Project
- Kickoff meeting1 hour to establish a submission process and set up office hours with HRP staff.
- Stakeholder trainingIRB 101 webinar for students, recorded for future use.
- Presentation slides1 customized presentation.
- IRB determinationExempt reviews, completion of checklists, determination letter generated.
- Program durationExpected program duration of 5 months.
Compliance Assessment
Compliance Assessment — HRPP / IRB / IACUC
- Kickoff meeting1 hour to outline current pain points or program gaps.
- Document reviewSOPs, checklists, templates and sample minutes; inspection records; review of 1–3 active projects (maximum 20 hours).
- Closeout meetingSummary report plus a stakeholder meeting to review observations and action items.
Checkup
Checkup — IRB Reliance
- Kickoff meeting1 hour to map your reliance model, internal review scope and local ancillary-review triggers.
- Process review2 recent projects reviewed against local requirements to identify strengths and growth areas.
- Document reviewRelevant templates, checklists and SOPs, determined at kickoff.
- Personnel1 hour of Q&A with key staff.
- Templates1 template policy and 1 template checklist; existing templates receive feedback in the report.
- Closeout meetingEngagement report with observations and action items.
Compliance Review
Compliance Review — SOP Essential
- Kickoff meeting1 hour to set the focus of the SOP evaluation.
- Document reviewIRB SOPs against the Common Rule (45 CFR 46), FDA (21 CFR 50, 56) and AAHRPP standards; application, staff screening and member initial-review checklists; chair meeting agenda.
- DeliverablesWritten report with gap analysis, observations and action items; 2 study files checked for consistent SOP application; up to 5 template SOPs or checklists.
- Closeout meeting1-hour meeting with HRPP/IRB leadership to review the final report.
Staffing
Staffing — Short Term Staffing
- Kickoff meeting1 hour.
- Consultant profileSeasoned IRB professionals with extensive operations experience, focused on backlog or new incoming submissions.
- Ramp-upMinimal training required; work begins as soon as system access is established.
- Personnel10 hours per week for 8 weeks.
- Closeout meetingEngagement wrap-up with HRP leadership.
Conflict of Interest
Conflict of Interest — COI
- Kickoff meeting1 hour to scope your conflict of interest review process.
- Document reviewCOI policies, disclosure forms and review documentation.
- Closeout meetingReport with observations and recommended action items.
Operational Effectiveness
Operational Effectiveness — Compliance Software
- Kickoff meeting1 hour — overview of existing software and workflows; select 1–2 workflows for assessment, such as initial application or full board review.
- Document reviewLimited-scope review of related SOPs to confirm consistency with electronic submission workflows and forms.
- Assessment3–5 recent submissions traced end to end: is the system used as intended, are there inefficiencies or bypassed steps, and does it match the SOP? Plus 3 stakeholder interviews.
- DeliverablesPolicy / system alignment matrix plus a written report on user adoption, information quality, system compliance and action items.
- Closeout meeting1-hour stakeholder meeting with HRPP/IRB leadership to review the final report.
