Master the IRB submission pipeline at portfolio scale — initial submissions, continuing reviews, amendments, and safety reports flowing through multiple IRBs simultaneously. This course covers multi-IRB navigation, regulatory authority interactions including FDA Form 1572 management and clinical holds, and the stakeholder communication systems that keep submissions moving across every active study at your site.
This course is part of the Regulatory Coordinator track. Enroll once to access all courses and exams.
Manage the complete IRB/IEC submission lifecycle -- from initial application through continuing review and study closure -- across a multi-study portfolio (ICH E6(R3) Annex 1, Sections 1.1-1.5 and 2.4)
Design submission tracking systems and quality control workflows that prevent missed deadlines, incomplete packages, and IRB lapses across concurrent studies
Navigate the operational differences between central IRB, local IRB, and reliance agreement models, adapting submission strategies to each structure
Coordinate stakeholder communications during the submission process, including PI signature collection, sponsor notification requirements, and IRB correspondence management
8 modules, 31 lessons, and 8 knowledge checks — all self-paced.
4 lessons · 3 hours
Defines the operational shift from per-study submission execution to portfolio-level pipeline management, identifying five pipeline-only capabilities and the failure modes that emerge without them.
Enroll in the Regulatory Coordinator track to access this course, all exams, and your certificate.
Master the IRB submission pipeline at portfolio scale — initial submissions, continuing reviews, amendments, and safety reports flowing through multiple IRBs simultaneously. This course covers multi-IRB navigation, regulatory authority interactions including FDA Form 1572 management and clinical holds, and the stakeholder communication systems that keep submissions moving across every active study at your site.
This course is part of the Regulatory Coordinator track. Enroll once to access all courses and exams.
Manage the complete IRB/IEC submission lifecycle -- from initial application through continuing review and study closure -- across a multi-study portfolio (ICH E6(R3) Annex 1, Sections 1.1-1.5 and 2.4)
Design submission tracking systems and quality control workflows that prevent missed deadlines, incomplete packages, and IRB lapses across concurrent studies
Navigate the operational differences between central IRB, local IRB, and reliance agreement models, adapting submission strategies to each structure
Coordinate stakeholder communications during the submission process, including PI signature collection, sponsor notification requirements, and IRB correspondence management
8 modules, 31 lessons, and 8 knowledge checks — all self-paced.
4 lessons · 3 hours
Defines the operational shift from per-study submission execution to portfolio-level pipeline management, identifying five pipeline-only capabilities and the failure modes that emerge without them.
Enroll in the Regulatory Coordinator track to access this course, all exams, and your certificate.
Manage FDA Form 1572 updates, financial disclosure obligations (21 CFR 54), and other regulatory authority interactions that arise at the investigator site level
Execute continuing review processes with the documentation rigor and timeline discipline required to prevent regulatory lapses that would shut down enrollment
Teaches the regulatory coordinator to conduct a submission landscape assessment, cataloguing every active study, its IRB, its deadlines, and its current regulatory status to make the aggregate workload visible.
Teaches the RC to design, build, and maintain a submission tracking system with fields, statuses, alerts, and maintenance protocols calibrated to portfolio size and IRB complexity.
Teaches the RC to design a multi-stage QC process for IRB submissions, apply risk-calibrated QC intensity, and create standardized checklists adaptable across IRBs and delegable to CRCs.
4 lessons · 3 hours
Teaches the RC to design a reusable initial submission assembly workflow across concurrent study start-ups, identifying component sourcing bottlenecks and activation timeline risks when managing multiple simultaneous submissions.
Teaches the RC to manage CIRB submission workflows at portfolio scale, navigate retained institutional obligations under reliance agreements, and design preventive controls for the failure points unique to central IRB models.
Teaches the RC to manage local IRB submission strategy at portfolio scale, including meeting cycle navigation, deadline calculation, batching and sequencing decisions, and reviewer dynamics across concurrent studies before the same committee.
Teaches the RC to design tiered QC checklists for initial submissions, implement a delegation model that distributes review responsibility between CRCs and the RC, and evaluate QC effectiveness through quarterly metrics and continuous improvement cycles.
4 lessons · 3 hours
Quantifies the operational and regulatory consequences of a continuing review lapse and establishes the early-warning infrastructure that prevents it across a multi-study portfolio.
Teaches the RC to systematize continuing review package assembly through standardized data collection processes, staggered preparation workflows, and modular templates adaptable across IRBs.
Teaches portfolio-level continuing review management strategies: calendar analysis for workload distribution, batching decisions for same-IRB studies, and the 60-day rule as a portfolio standard.
Teaches the RC to manage post-approval IRB correspondence as a portfolio-level workflow, with tracking systems, routing protocols, escalation paths, and pattern analysis for systemic improvement.
5 lessons · 4 hours
Maps the five major IRB models as operational realities the RC must navigate simultaneously, analyzing their distinct characteristics and building a reference guide for portfolio-level IRB management.
Analyzes the regulatory architecture of reliance agreements at portfolio scale, building tracking systems for retained institutional obligations and workflows that accommodate structural variation across studies.
Designs a multi-IRB management framework that standardizes internal processes while accommodating external variability, creating IRB-specific submission playbooks for CRC delegation.
Applies systematic transition management for mid-study IRB changes, designing stakeholder notification workflows and evaluating risk points including gap periods, consent continuity, and continuing review date resets.
Creates an institutional knowledge repository for each IRB the site works with, analyzing impact on portfolio planning and evaluating ethical boundaries of adapting to IRB-specific operational patterns.
4 lessons · 3 hours
Analyzes the commitments embedded in FDA Form 1572 per 21 CFR 312.53, designs portfolio-level 1572 maintenance tracking, and evaluates the regulatory risk of outdated investigator information across IND studies.
Analyzes 21 CFR Part 54 financial disclosure requirements from the RC's coordination perspective, designs portfolio-level tracking systems for multi-study investigators, and evaluates the complexity of financial disclosure when investigators hold roles across multiple sponsors.
Analyzes regulatory authority actions affecting the investigator site, designs a site-level clinical hold response protocol, and evaluates the RC's coordination role versus PI and sponsor decision-making authority during regulatory events.
Analyzes major non-U.S. regulatory frameworks and their site-level implications, designs communication protocols for sponsor notifications about international regulatory actions, and evaluates the portfolio impact of multi-regional requirements in global trials.
3 lessons · 2 hours
Designs a portfolio-level PI engagement workflow — batch signature sessions, prioritized signing queues, pre-briefing protocols — and analyzes root causes of PI disengagement with escalation boundaries per ICH E6(R3) Section 2.3.1.
Designs standardized notification workflows per ICH E6(R3) Sections 3.8.2 and 3.11.4, applies proactive delay communication, and analyzes the three tiers of information flow — regulatory-required, contractual, and relationship-building.
Designs an IRB correspondence management system per ICH E6(R3) Appendix C, C.2.1 and C.3.1(a), analyzes regulatory narrative continuity across submissions over time, and creates response templates and routing protocols for delegation.
3 lessons · 2 hours
Designs a comprehensive close-out checklist mapping three-stakeholder requirements (IRB, sponsor, institution), analyzes sequencing dependencies, and evaluates the consequences of incomplete close-out including phantom continuing review obligations and audit findings.
Designs a data aggregation process for final study reports per ICH E6(R3) Annex 1, Section 2.13, applies a standardized report template enabling CRC delegation with RC oversight, and analyzes common errors with QC review implementation.
Designs a parallel close-out plan per ICH E6(R3) Annex 1, Section 3.10, analyzes portfolio risk when closure bandwidth threatens ongoing study operations, and creates a close-out status dashboard for real-time visibility.
4 lessons · 3 hours
Designs the comprehensive regulatory calendar as the RC's master operating document, defines its data architecture, populates it from real submission types, and evaluates platform trade-offs.
Analyzes deadline conflict types (volume, resource, dependency) and their severity, applies tactical resolution techniques across submission types, and designs automated conflict detection within the regulatory calendar.
Builds a 90-day rolling forecast from known deadlines, seasonal patterns, and pipeline intelligence, applies capacity planning to match projected workload against available resources, and evaluates the forecast as a management communication instrument.
Creates executive-level reports translating regulatory pipeline data into institutional performance metrics, applies data-driven argumentation for resource requests, and evaluates the RC's role as bridge between operations and institutional decision-making.
Manage FDA Form 1572 updates, financial disclosure obligations (21 CFR 54), and other regulatory authority interactions that arise at the investigator site level
Execute continuing review processes with the documentation rigor and timeline discipline required to prevent regulatory lapses that would shut down enrollment
Teaches the regulatory coordinator to conduct a submission landscape assessment, cataloguing every active study, its IRB, its deadlines, and its current regulatory status to make the aggregate workload visible.
Teaches the RC to design, build, and maintain a submission tracking system with fields, statuses, alerts, and maintenance protocols calibrated to portfolio size and IRB complexity.
Teaches the RC to design a multi-stage QC process for IRB submissions, apply risk-calibrated QC intensity, and create standardized checklists adaptable across IRBs and delegable to CRCs.
4 lessons · 3 hours
Teaches the RC to design a reusable initial submission assembly workflow across concurrent study start-ups, identifying component sourcing bottlenecks and activation timeline risks when managing multiple simultaneous submissions.
Teaches the RC to manage CIRB submission workflows at portfolio scale, navigate retained institutional obligations under reliance agreements, and design preventive controls for the failure points unique to central IRB models.
Teaches the RC to manage local IRB submission strategy at portfolio scale, including meeting cycle navigation, deadline calculation, batching and sequencing decisions, and reviewer dynamics across concurrent studies before the same committee.
Teaches the RC to design tiered QC checklists for initial submissions, implement a delegation model that distributes review responsibility between CRCs and the RC, and evaluate QC effectiveness through quarterly metrics and continuous improvement cycles.
4 lessons · 3 hours
Quantifies the operational and regulatory consequences of a continuing review lapse and establishes the early-warning infrastructure that prevents it across a multi-study portfolio.
Teaches the RC to systematize continuing review package assembly through standardized data collection processes, staggered preparation workflows, and modular templates adaptable across IRBs.
Teaches portfolio-level continuing review management strategies: calendar analysis for workload distribution, batching decisions for same-IRB studies, and the 60-day rule as a portfolio standard.
Teaches the RC to manage post-approval IRB correspondence as a portfolio-level workflow, with tracking systems, routing protocols, escalation paths, and pattern analysis for systemic improvement.
5 lessons · 4 hours
Maps the five major IRB models as operational realities the RC must navigate simultaneously, analyzing their distinct characteristics and building a reference guide for portfolio-level IRB management.
Analyzes the regulatory architecture of reliance agreements at portfolio scale, building tracking systems for retained institutional obligations and workflows that accommodate structural variation across studies.
Designs a multi-IRB management framework that standardizes internal processes while accommodating external variability, creating IRB-specific submission playbooks for CRC delegation.
Applies systematic transition management for mid-study IRB changes, designing stakeholder notification workflows and evaluating risk points including gap periods, consent continuity, and continuing review date resets.
Creates an institutional knowledge repository for each IRB the site works with, analyzing impact on portfolio planning and evaluating ethical boundaries of adapting to IRB-specific operational patterns.
4 lessons · 3 hours
Analyzes the commitments embedded in FDA Form 1572 per 21 CFR 312.53, designs portfolio-level 1572 maintenance tracking, and evaluates the regulatory risk of outdated investigator information across IND studies.
Analyzes 21 CFR Part 54 financial disclosure requirements from the RC's coordination perspective, designs portfolio-level tracking systems for multi-study investigators, and evaluates the complexity of financial disclosure when investigators hold roles across multiple sponsors.
Analyzes regulatory authority actions affecting the investigator site, designs a site-level clinical hold response protocol, and evaluates the RC's coordination role versus PI and sponsor decision-making authority during regulatory events.
Analyzes major non-U.S. regulatory frameworks and their site-level implications, designs communication protocols for sponsor notifications about international regulatory actions, and evaluates the portfolio impact of multi-regional requirements in global trials.
3 lessons · 2 hours
Designs a portfolio-level PI engagement workflow — batch signature sessions, prioritized signing queues, pre-briefing protocols — and analyzes root causes of PI disengagement with escalation boundaries per ICH E6(R3) Section 2.3.1.
Designs standardized notification workflows per ICH E6(R3) Sections 3.8.2 and 3.11.4, applies proactive delay communication, and analyzes the three tiers of information flow — regulatory-required, contractual, and relationship-building.
Designs an IRB correspondence management system per ICH E6(R3) Appendix C, C.2.1 and C.3.1(a), analyzes regulatory narrative continuity across submissions over time, and creates response templates and routing protocols for delegation.
3 lessons · 2 hours
Designs a comprehensive close-out checklist mapping three-stakeholder requirements (IRB, sponsor, institution), analyzes sequencing dependencies, and evaluates the consequences of incomplete close-out including phantom continuing review obligations and audit findings.
Designs a data aggregation process for final study reports per ICH E6(R3) Annex 1, Section 2.13, applies a standardized report template enabling CRC delegation with RC oversight, and analyzes common errors with QC review implementation.
Designs a parallel close-out plan per ICH E6(R3) Annex 1, Section 3.10, analyzes portfolio risk when closure bandwidth threatens ongoing study operations, and creates a close-out status dashboard for real-time visibility.
4 lessons · 3 hours
Designs the comprehensive regulatory calendar as the RC's master operating document, defines its data architecture, populates it from real submission types, and evaluates platform trade-offs.
Analyzes deadline conflict types (volume, resource, dependency) and their severity, applies tactical resolution techniques across submission types, and designs automated conflict detection within the regulatory calendar.
Builds a 90-day rolling forecast from known deadlines, seasonal patterns, and pipeline intelligence, applies capacity planning to match projected workload against available resources, and evaluates the forecast as a management communication instrument.
Creates executive-level reports translating regulatory pipeline data into institutional performance metrics, applies data-driven argumentation for resource requests, and evaluates the RC's role as bridge between operations and institutional decision-making.