Design a site-level essential records infrastructure that meets ICH E6(R3) Appendix C requirements across all active studies, applying the essentiality framework to determine what must be retained, in what form, and for how long
Implement version control, filing taxonomy, and retrieval systems that maintain document currency and accessibility across a multi-study portfolio
Evaluate electronic document management systems for regulatory compliance, including 21 CFR Part 11 requirements for electronic records and signatures (ICH E6(R3) Annex 1, Sections 4.2-4.3)
Establish quality control processes for essential records that detect and correct deficiencies before they become inspection findings
7 modules, 28 lessons, and 7 knowledge checks — all self-paced.
4 lessons · 3 hours
Traces the terminological and conceptual shift from 'essential documents' in E6(R2) to 'essential records' in E6(R3) Appendix C and its infrastructure implications.
Enroll in the Regulatory Coordinator track to access this course, all exams, and your certificate.
Design a site-level essential records infrastructure that meets ICH E6(R3) Appendix C requirements across all active studies, applying the essentiality framework to determine what must be retained, in what form, and for how long
Implement version control, filing taxonomy, and retrieval systems that maintain document currency and accessibility across a multi-study portfolio
Evaluate electronic document management systems for regulatory compliance, including 21 CFR Part 11 requirements for electronic records and signatures (ICH E6(R3) Annex 1, Sections 4.2-4.3)
Establish quality control processes for essential records that detect and correct deficiencies before they become inspection findings
7 modules, 28 lessons, and 7 knowledge checks — all self-paced.
4 lessons · 3 hours
Traces the terminological and conceptual shift from 'essential documents' in E6(R2) to 'essential records' in E6(R3) Appendix C and its infrastructure implications.
Enroll in the Regulatory Coordinator track to access this course, all exams, and your certificate.
The CRC track teaches coordinators to maintain a regulatory binder for a single study -- filing documents, tracking versions, keeping the binder inspection-ready. This course operates at an entirely different level. It teaches you to design the document management infrastructure that governs how every study's records are organized, stored, controlled, and retrieved across the entire site. The sequencing is deliberate. This course follows the three operational courses (submissions, amendments, safety) because you cannot design a records infrastructure until you understand the operational processes that generate the records. ICH E6(R3) changed "essential documents" to "essential records" in Appendix C -- a deliberate terminological shift reflecting that what sites must retain encompasses documents, data, and relevant metadata in any format. This course takes that shift seriously.
This course is part of the Regulatory Coordinator track. Enroll once to access all courses and exams.
Manage the records lifecycle from creation through active use, archiving, and eventual destruction per ICH E6(R3) Annex 1, Section 4.2.7-4.2.8
Coordinate essential records practices between the RC, CRCs, investigators, and sponsors to ensure consistent record management across the site
Teaches the RC to apply ICH E6(R3) Appendix C, Section C.3 criteria as the analytical framework governing what the site's records infrastructure must accommodate.
Establishes the temporal dimension of essential record generation across trial phases for the RC managing records infrastructure across studies simultaneously in different lifecycle phases.
Maps every Section 2.12 requirement to the operational infrastructure the RC must provide, clarifying the distinction between the investigator's nondelegable regulatory responsibility and the RC's operational supporting role.
4 lessons · 3 hours
Establishes the three foundational principles that distinguish a site-level records architecture from a study-level binder: standardization, scalability, and retrievability.
Teaches the RC to design filing taxonomies and naming conventions that survive staff turnover, accommodate sponsor-specific requirements, and remain intuitive to anyone who needs to locate a record.
Teaches the RC to design a records architecture that clearly delineates study-level records from site-level records with clear cross-referencing procedures.
Teaches the RC to build scalability into the records architecture from the outset, using modular design principles that allow the system to grow as the site's research portfolio expands.
4 lessons · 3 hours
Establishes the framework for site-level version control of essential records by defining the three operational components -- trigger identification, tracking mechanisms, and verification procedures -- that maintain document currency across a multi-study portfolio.
Applies the trigger-tracking-verification framework to protocol version management across a multi-study portfolio, designing a version registry with status indicators, transition workflows grounded in ICH E6(R3) Sections 2.4 and 2.5, and quality checks to detect protocol version discrepancies.
Applies the trigger-tracking-verification framework to the highest-stakes version control challenge at the investigator site: maintaining the documented three-way relationship between protocol versions, consent form versions, and IRB approval dates across a multi-study portfolio.
Teaches the design of portfolio-wide expiration tracking systems that provide tiered advance notifications, assign renewal responsibility, and verify that renewed documents replace expired versions across all affected study binders.
4 lessons · 3 hours
Provides the RC with a working understanding of 21 CFR Part 11 and ICH E6(R3) Section 4.3 -- what they require, where they overlap, and how the FDA's risk-based enforcement approach shapes practical compliance expectations.
Provides a structured evaluation framework for electronic document management systems covering validation status, audit trail capabilities, access controls, and data integrity features.
Teaches the RC to govern hybrid paper-electronic environments with clear policies defining the official record, certified copy requirements under Appendix C, C.2.9, and quality controls that prevent version discrepancies and audit trail gaps between systems.
Teaches the RC to design and enforce the three pillars of electronic system governance -- user access management per Section 4.3.8, security controls per Section 4.3.3, and audit trail review procedures per Section 4.2.2 -- as site-level procedures that persist across studies and staff changes.
4 lessons · 3 hours
Teaches the RC to build quality checks into the daily flow of records operations so that deficiencies are detected and corrected as they occur, not six months later during a monitoring visit.
Teaches the RC to design and conduct self-inspection processes that identify records deficiencies before monitors or inspectors find them, and to track corrective actions to closure.
Teaches the RC to analyze patterns across monitoring findings from multiple studies, trace recurring findings to infrastructure failures rather than individual errors, and redesign systems to prevent systemic recurrence.
Teaches the RC to design a records quality metrics program with defined metrics, collection methods, and reporting intervals that make portfolio-level records quality visible and actionable for site leadership and inspections.
4 lessons · 3 hours
Addresses the operational challenge of maintaining records currency during the busiest phase of the study lifecycle, across every active study in the portfolio.
Teaches the structured archiving process -- completeness verification, format preservation, access documentation, and secure storage -- required when transitioning records from active use to long-term retention.
Teaches the analytical framework for resolving retention period conflicts and the tracking system that manages retention across a portfolio of closed studies spanning different years, sponsors, and regulatory regimes.
Teaches the complete record destruction procedure -- from eligibility determination through documented execution -- including the approval chain, hold mechanisms for pending regulatory actions or litigation, and the destruction log that closes the records lifecycle.
4 lessons · 3 hours
Teaches the RC to create site-level records management SOPs that codify the records architecture, filing taxonomy, version control system, and quality check procedures developed in Modules 1-6 into authoritative governance documents.
Teaches the RC to coordinate distributed records responsibilities with clear accountability, defined handoff points, and escalation procedures using the RACI framework anchored in ICH E6(R3) Section 2.12.11 and Section 2.3.
Teaches the RC to manage diverse sponsor documentation requirements without fragmenting the site's records infrastructure -- accommodating legitimate requirements while maintaining consistency.
The final lesson of the course -- teaches the RC to use records quality metrics for portfolio management decisions, stakeholder reporting, and continuous improvement, building on the metric definitions and collection methods established in Module 5.
The CRC track teaches coordinators to maintain a regulatory binder for a single study -- filing documents, tracking versions, keeping the binder inspection-ready. This course operates at an entirely different level. It teaches you to design the document management infrastructure that governs how every study's records are organized, stored, controlled, and retrieved across the entire site. The sequencing is deliberate. This course follows the three operational courses (submissions, amendments, safety) because you cannot design a records infrastructure until you understand the operational processes that generate the records. ICH E6(R3) changed "essential documents" to "essential records" in Appendix C -- a deliberate terminological shift reflecting that what sites must retain encompasses documents, data, and relevant metadata in any format. This course takes that shift seriously.
This course is part of the Regulatory Coordinator track. Enroll once to access all courses and exams.
Manage the records lifecycle from creation through active use, archiving, and eventual destruction per ICH E6(R3) Annex 1, Section 4.2.7-4.2.8
Coordinate essential records practices between the RC, CRCs, investigators, and sponsors to ensure consistent record management across the site
Teaches the RC to apply ICH E6(R3) Appendix C, Section C.3 criteria as the analytical framework governing what the site's records infrastructure must accommodate.
Establishes the temporal dimension of essential record generation across trial phases for the RC managing records infrastructure across studies simultaneously in different lifecycle phases.
Maps every Section 2.12 requirement to the operational infrastructure the RC must provide, clarifying the distinction between the investigator's nondelegable regulatory responsibility and the RC's operational supporting role.
4 lessons · 3 hours
Establishes the three foundational principles that distinguish a site-level records architecture from a study-level binder: standardization, scalability, and retrievability.
Teaches the RC to design filing taxonomies and naming conventions that survive staff turnover, accommodate sponsor-specific requirements, and remain intuitive to anyone who needs to locate a record.
Teaches the RC to design a records architecture that clearly delineates study-level records from site-level records with clear cross-referencing procedures.
Teaches the RC to build scalability into the records architecture from the outset, using modular design principles that allow the system to grow as the site's research portfolio expands.
4 lessons · 3 hours
Establishes the framework for site-level version control of essential records by defining the three operational components -- trigger identification, tracking mechanisms, and verification procedures -- that maintain document currency across a multi-study portfolio.
Applies the trigger-tracking-verification framework to protocol version management across a multi-study portfolio, designing a version registry with status indicators, transition workflows grounded in ICH E6(R3) Sections 2.4 and 2.5, and quality checks to detect protocol version discrepancies.
Applies the trigger-tracking-verification framework to the highest-stakes version control challenge at the investigator site: maintaining the documented three-way relationship between protocol versions, consent form versions, and IRB approval dates across a multi-study portfolio.
Teaches the design of portfolio-wide expiration tracking systems that provide tiered advance notifications, assign renewal responsibility, and verify that renewed documents replace expired versions across all affected study binders.
4 lessons · 3 hours
Provides the RC with a working understanding of 21 CFR Part 11 and ICH E6(R3) Section 4.3 -- what they require, where they overlap, and how the FDA's risk-based enforcement approach shapes practical compliance expectations.
Provides a structured evaluation framework for electronic document management systems covering validation status, audit trail capabilities, access controls, and data integrity features.
Teaches the RC to govern hybrid paper-electronic environments with clear policies defining the official record, certified copy requirements under Appendix C, C.2.9, and quality controls that prevent version discrepancies and audit trail gaps between systems.
Teaches the RC to design and enforce the three pillars of electronic system governance -- user access management per Section 4.3.8, security controls per Section 4.3.3, and audit trail review procedures per Section 4.2.2 -- as site-level procedures that persist across studies and staff changes.
4 lessons · 3 hours
Teaches the RC to build quality checks into the daily flow of records operations so that deficiencies are detected and corrected as they occur, not six months later during a monitoring visit.
Teaches the RC to design and conduct self-inspection processes that identify records deficiencies before monitors or inspectors find them, and to track corrective actions to closure.
Teaches the RC to analyze patterns across monitoring findings from multiple studies, trace recurring findings to infrastructure failures rather than individual errors, and redesign systems to prevent systemic recurrence.
Teaches the RC to design a records quality metrics program with defined metrics, collection methods, and reporting intervals that make portfolio-level records quality visible and actionable for site leadership and inspections.
4 lessons · 3 hours
Addresses the operational challenge of maintaining records currency during the busiest phase of the study lifecycle, across every active study in the portfolio.
Teaches the structured archiving process -- completeness verification, format preservation, access documentation, and secure storage -- required when transitioning records from active use to long-term retention.
Teaches the analytical framework for resolving retention period conflicts and the tracking system that manages retention across a portfolio of closed studies spanning different years, sponsors, and regulatory regimes.
Teaches the complete record destruction procedure -- from eligibility determination through documented execution -- including the approval chain, hold mechanisms for pending regulatory actions or litigation, and the destruction log that closes the records lifecycle.
4 lessons · 3 hours
Teaches the RC to create site-level records management SOPs that codify the records architecture, filing taxonomy, version control system, and quality check procedures developed in Modules 1-6 into authoritative governance documents.
Teaches the RC to coordinate distributed records responsibilities with clear accountability, defined handoff points, and escalation procedures using the RACI framework anchored in ICH E6(R3) Section 2.12.11 and Section 2.3.
Teaches the RC to manage diverse sponsor documentation requirements without fragmenting the site's records infrastructure -- accommodating legitimate requirements while maintaining consistency.
The final lesson of the course -- teaches the RC to use records quality metrics for portfolio management decisions, stakeholder reporting, and continuous improvement, building on the metric definitions and collection methods established in Module 5.