Module 1: The CRC in the clinical trial ecosystem

1The evolution of the CRC role: from study nurse to research professional
2Where CRCs work: academic medical centers, community sites, and dedicated research organizations
3The investigator-coordinator relationship: delegation, accountability, and ICH E6(R3) Section 2.3
4Understanding sponsor and CRO expectations of your site
Module Quiz10 questions

Module 2: Your professional relationships

1Working with the principal investigator and sub-investigators
2The CRC-CRA relationship: collaboration, not adversary
3Communicating with sponsors, IRBs, and regulatory authorities
4Building trust with participants and their families

Module 3: A day in the life -- operational realities

1Morning to close: a realistic CRC day across study phases
2Managing multiple concurrent studies without drowning
3The administrative burden: tracking, filing, reporting, and following up
4When things go wrong: managing the unexpected

Module 4: Core competencies and self-assessment

1Technical competencies: regulatory knowledge, protocol interpretation, and systems fluency
2Interpersonal competencies: communication, empathy, and professional boundaries
3Organizational competencies: the systems that keep you afloat
4Self-assessment and honest gap analysis

Module 5: Quality mindset for the CRC

1Quality by design: how E6(R3) changed the quality conversation
2Thinking in terms of Critical to Quality factors at the site level
3Preventing deviations: the CRC as the first line of defense
4When deviations happen: documentation, reporting, and corrective thinking

Module 6: Career pathways and professional development

1The CRC career ladder: from entry-level to senior and lead roles
2Lateral moves: CRA, regulatory affairs, project management, and data management
3Certifications that matter: CCRC, CCRP, and beyond
4Building your professional brand and network

Module 7: Leadership and mentorship

1The Lead CRC role: portfolio management and team oversight
2Training and mentoring new CRCs effectively
3Managing up: influencing investigators, site leadership, and institutional priorities
Module Quiz10 questions

Course 1 Final Exam: The CRC Role -- Foundations and Career Path50 questions · 90 min · 75% to pass · 3 attempts

Study Start-Up and Site Activation

View Course Details

7 modules

28 lessons

Module 1: Protocol receipt and initial review

1Receiving a new protocol: what to look for in the first 48 hours
2Operational protocol review: translating science into site workflow
3Identifying red flags: procedures your site cannot support
4The protocol synopsis as your operational roadmap
Module Quiz10 questions

Module 2: Feasibility assessment

1Patient population assessment: do you actually have these patients?
2Resource and infrastructure evaluation: staff, space, equipment, and time
3Competing studies and therapeutic area saturation: when your portfolio outgrows your patients
4Completing feasibility questionnaires and confidential disclosure agreements

Module 3: Budgets, contracts, and financial management

1Understanding clinical trial budgets: revenue, cost, and the space between
2Fair market value and anti-kickback considerations
3The contract negotiation process: what CRCs need to know
4Budget tracking and financial reconciliation during the study

Module 4: Regulatory submissions

1The FDA Form 1572: what it means and why it matters
2IRB/IEC initial submission packages: assembling the complete application
3Central IRB vs. local IRB: different processes, same principles
4Regulatory authority notifications and institutional requirements

Module 5: Essential record collection

1The essential records checklist: what you need and when you need it
2Investigator and site staff documentation: CVs, licenses, training records, and delegation logs
3Laboratory documentation: certifications, normal ranges, and accreditation
4Sponsor-provided documents: protocol, IB, IP information, and study-specific materials

Module 6: The site initiation visit

1Preparing for the SIV: logistics, materials, and team readiness
2During the SIV: your role, your questions, and what to document
3Post-SIV action items: turning training into operational readiness
4From SIV to first patient: the final activation checklist

Module 7: Activation and enrollment readiness

1System access and configuration: EDC, IVRS/IWRS, and study portals
2Internal workflows: establishing visit templates, order sets, and lab kits
3Pre-enrollment team readiness checks
4The first enrollment: a walkthrough from identification to randomization

Final Exam: Study Start-Up and Site Activation50 questions · 90 min · 80% to pass · 3 attempts

Informed Consent in Practice

View Course Details

7 modules

28 lessons

The Ethical and Regulatory Foundations of Consent

1From Nuremberg to E6(R3): The Ethical Imperative Behind Informed Consent
2ICH E6(R3) Section 2.8: The Consent Requirements in Full
3The CRC's Role in the Consent Process: Delegation, Scope, and Accountability
4Consent as a Process, Not an Event: The Ongoing Nature of Informed Consent
Module Quiz10 questions

Preparing for the Consent Encounter

1Mastering the Consent Document: Knowing Every Section and Why It Matters
2The Consent Environment: Privacy, Time, and Freedom from Coercion
3Preparing for Common Questions and Concerns
4Cultural and Linguistic Considerations in Consent Preparation

Conducting the Consent Conversation

1Opening the Conversation: Setting Tone and Expectations
2Walking Through the Consent Document: Pacing, Emphasis, and Plain Language
3Addressing Risks, Benefits, and Alternatives Honestly
4The Participant's Questions: Encouraging and Answering Them Well

Assessing and Ensuring Comprehension

1Why 'Do You Have Any Questions?' Is Not Enough
2Teach-Back Methods: Asking Participants to Explain in Their Own Words
3Assessing Comprehension of Key Concepts: Randomization, Placebo, Voluntariness
4When Comprehension Is Inadequate: Next Steps and Ethical Obligations

Special Populations and Consent Challenges

1Pediatric Consent and Assent: Age-Appropriate Communication
2Legally Authorized Representatives: Identifying, Consenting, and Documenting
3Participants with Cognitive Impairment: Assessing Capacity and Protecting Rights
4Short-Form Consent and Consent in Emergency Situations

Reconsent and Ongoing Consent Obligations

1Protocol Amendments That Trigger Reconsent: Identifying Which Changes Matter
2The Reconsent Process: Logistics, Timing, and Participant Communication
3Safety-Driven Reconsent: New Risks, IB Updates, and DSMB Communications
4Ongoing Consent: Keeping Participants Informed Between Formal Reconsent Events

Consent Documentation and Quality

1The Consent Form as a Legal Document: Signatures, Dates, and Required Elements
2Documenting the consent process beyond the signature page
3Consent form storage, access, and participant copies
4Common consent documentation errors and how to prevent them

Final Exam: Informed Consent in Practice50 questions · 75 min · 80% to pass · 3 attempts

Participant Management: Screening to Retention

View Course Details

8 modules

32 lessons

Module 1: Recruitment strategy and ethics

1Building a recruitment plan: channels, timelines, and metrics
2IRB-approved recruitment materials: what you can and cannot say
3Ethical recruitment: the line between motivation and coercion
4Physician referral networks and community outreach
Module Quiz12 questions

Module 2: Pre-screening and eligibility assessment

1Medical record pre-screening: what to look for and HIPAA considerations
2Telephone pre-screening: scripts, scope, and documentation
3Database and registry-based identification strategies
4The pre-screening log: tracking and documenting your funnel

Module 3: The screening visit

1Screening visit workflow: from arrival to departure
2Executing screening procedures per protocol
3Eligibility determination: applying inclusion/exclusion criteria with precision
4Screen failures: documentation, communication, and rescreening decisions

Module 4: Enrollment and randomization

1Enrollment eligibility confirmation and documentation
2Using IVRS/IWRS: randomization and treatment assignment systems
3Enrollment documentation: what must be recorded and where
4Managing enrollment targets and communicating with the sponsor

Module 5: Visit execution and management

1Visit scheduling: windows, conflicts, and participant communication
2Visit preparation: checklists, supplies, and coordination with ancillary departments
3Conducting the study visit: procedure execution and real-time documentation
4Post-visit follow-up: result reviews, participant communication, and next-visit preparation

Module 6: Investigational product accountability

1IP receipt, verification, and storage per ICH E6(R3) Annex 1, Section 2.10
2IP dispensing and participant compliance assessment
3IP reconciliation and accountability logs
4Temperature excursions, expiration, and handling deviations

Module 7: Protocol deviations and CAPA

1Types of deviations: major, minor, and the gray area between
2Identifying deviations in real time vs. retrospective discovery
3Documentation, reporting, and root cause analysis
4Corrective and preventive actions: from quick fixes to systemic improvements

Module 8: Retention, withdrawal, and loss to follow-up

1Retention strategies that respect participant autonomy
2When participants want to withdraw: rights, process, and documentation per ICH E6(R3) Annex 1, Section 2.9
3Participant discontinuation vs. study withdrawal: understanding the distinction
4Lost to follow-up: when and how to stop trying

Final Exam: Participant Management -- Screening to Retention55 questions · 90 min · 80% to pass · 3 attempts

Data Collection and Source Documentation

View Course Details

7 modules

28 lessons

Module 1: Data integrity principles for the CRC

1Data integrity per ICH E6(R3): the eight criteria that govern every data point you create
2ICH E6(R3) data governance: what changed and why it matters (Annex 1, Section 4)
3The consequences of data integrity failures: real cases, real outcomes
4The CRC as the first line of data defense
Module Quiz10 questions

Module 2: Source documentation mastery

1What qualifies as a source document: definitions and examples per ICH E6(R3)
2Designing and using source document worksheets
3The electronic medical record as source: opportunities and pitfalls
4Real-time documentation: why 'I will chart it later' is never acceptable

Module 3: Source-to-CRF workflow

1Understanding the CRF: structure, completion guidelines, and common pitfalls
2Transcription discipline: source to CRF without error
3Self-QC techniques: catching your own mistakes before the monitor does
4Paper CRFs vs. electronic data capture: different systems, same principles

Module 4: Electronic data capture systems

1EDC fundamentals: navigating the interface, entering data, and saving work
2Edit checks and validation rules: understanding what the system is telling you
3Electronic signatures and the meaning of 'sign and lock'
4System access, training documentation, and 21 CFR Part 11 awareness

Module 5: Query management

1Understanding query types: automated edit checks, manual monitor queries, and medical queries
2Resolving queries: investigation, correction, and explanation
3Query resolution timelines and escalation procedures
4Reducing query volume through better initial data entry

Module 6: Data quality and the monitoring interface

1Source data verification: what monitors are checking and why
2Preparing for SDV: organizing source documents for efficient review
3Post-monitoring data corrections and reconciliation
4Remote monitoring and centralized data review: what you need to know

Module 7: Emerging data practices

1ePRO and eCOA: patient-reported outcomes in the digital age
2Wearable devices and sensor data: the CRC's role
3EHR-to-EDC integration: promises and practical realities
4Data governance for emerging technologies: applying ICH E6(R3) Section 4 to new paradigms

Final Exam: Data Collection and Source Documentation50 questions · 90 min · 80% to pass · 3 attempts

Safety Reporting and Pharmacovigilance for CRCs

View Course Details

7 modules

28 lessons

Module 1: Foundations of safety reporting

1Why safety reporting matters: from site reports to regulatory signals
2The regulatory framework: ICH E6(R3) Section 2.7, ICH E2A, and FDA requirements
3The CRC's role in the safety reporting chain
4Definitions that matter: adverse event, serious adverse event, SUSAR, and the distinctions between them
Module Quiz12 questions

Module 2: Adverse event identification

1Eliciting adverse events: open-ended questioning techniques
2Physical assessment and vital sign changes as AE indicators
3Laboratory abnormalities: when a lab value becomes an adverse event
4Between-visit AE identification: phone contacts, participant diaries, and spontaneous reports

Module 3: Adverse event assessment and grading

1Severity grading: CTCAE and protocol-specific grading scales
2Seriousness criteria: the SAE triggers you must know
3Expectedness: the Investigator's Brochure as your reference
4Causality assessment: the investigator's judgment and the CRC's contribution

Module 4: Adverse event documentation

1The AE source document: what to capture and how to capture it
2AE CRF completion: onset, resolution, severity, action taken, and outcome
3Narrative descriptions that tell the clinical story
4Concomitant medication documentation in the context of safety reporting

Module 5: Serious adverse event reporting

1Recognizing an SAE: the moment awareness triggers the clock
2Initial SAE reporting: the 24-hour timeline and what the initial report must contain
3SAE follow-up reports: updates, resolution, and final outcomes
4SAE reporting for different scenarios: hospitalizations, deaths, and pregnancy

Module 6: Safety communications and ongoing vigilance

1Investigator's Brochure updates: what changed and what it means for your site
2Sponsor safety letters and CIOMS/MedWatch reports
3DSMB and DMC communications: when the data monitoring committee speaks
4IRB/IEC reporting of safety information: meeting your institutional obligations

Module 7: Building a safety culture at your site

1Safety reporting training for the site team: what everyone needs to know
2Safety reporting systems: tracking, reminders, and quality checks
3Learning from safety events: using AE patterns to improve participant care
4The intersection of safety reporting and quality management

Final Exam: Safety Reporting and Pharmacovigilance for CRCs50 questions · 90 min · 80% to pass · 3 attempts

Monitoring, Close-Out & the Modern CRC

View Course Details

8 modules

32 lessons

Module 1: Understanding monitoring in the E6(R3) era

1The evolution of monitoring: from 100% SDV to risk-based approaches
2ICH E6(R3) monitoring framework: Annex 1, Section 3.11.4 in practice
3Types of monitoring: on-site, remote, centralized, and how they affect your work
4The monitoring plan: what sponsors and CROs are looking for and why
Module Quiz12 questions

Module 2: Preparing for monitoring visits

1Ongoing monitoring readiness: the weekly and monthly routines
2Pre-visit preparation: the two-week and two-day checklists
3Organizing source documents for efficient SDV
4Preparing participant charts and regulatory binders

Module 3: During the monitoring visit

1The monitoring visit day: logistics, workspace, and communication
2Supporting the monitor: what to provide, when to be available, and what to expect
3Handling difficult conversations: findings, disagreements, and escalation
4Same-day resolution: addressing issues while the monitor is still on-site

Module 4: Responding to findings and follow-up

1Reading and responding to monitoring visit reports
2Implementing corrective actions: timelines, documentation, and verification
3CAPA for monitoring findings: when is a pattern a systemic issue?
4Using monitoring feedback to improve site operations

Module 5: Audits and inspections

1Types of inspections: FDA, EMA, sponsor, and the differences that matter
2Preparing for a regulatory inspection: what to expect and how to ready your site
3During the inspection: your conduct, your rights, and your responsibilities
4Post-inspection: responding to FDA 483 observations and audit findings

Module 6: Study close-out

1Planning for close-out: starting preparation before the last patient last visit
2Final participant activities: end-of-study visits, transition to standard care, and unblinding
3Document reconciliation: closing every loop in the binder, CRF, and query log
4IP reconciliation, return, and destruction documentation

Module 7: Archiving and record retention

1Retention requirements: ICH, FDA, and institutional obligations
2Preparing documents for archiving: organization, indexing, and physical preparation
3Electronic records archiving and long-term accessibility
4The close-out monitoring visit and final regulatory notifications

Module 8: The modern CRC -- emerging practices and leadership

1eConsent: electronic consent systems, regulatory requirements, and participant experience
2Decentralized and hybrid trial designs: the CRC's evolving role
3Risk-based quality management in daily CRC practice
4CRC leadership in the evolving clinical trial landscape

Final Exam: Monitoring, Close-Out & the Modern CRC55 questions · 75 min · 75% to pass · 3 attempts

Module 1: The CRC in the clinical trial ecosystem

1The evolution of the CRC role: from study nurse to research professional
2Where CRCs work: academic medical centers, community sites, and dedicated research organizations
3The investigator-coordinator relationship: delegation, accountability, and ICH E6(R3) Section 2.3
4Understanding sponsor and CRO expectations of your site
Module Quiz10 questions

Module 2: Your professional relationships

1Working with the principal investigator and sub-investigators
2The CRC-CRA relationship: collaboration, not adversary
3Communicating with sponsors, IRBs, and regulatory authorities
4Building trust with participants and their families

Module 3: A day in the life -- operational realities

1Morning to close: a realistic CRC day across study phases
2Managing multiple concurrent studies without drowning
3The administrative burden: tracking, filing, reporting, and following up
4When things go wrong: managing the unexpected

Module 4: Core competencies and self-assessment

1Technical competencies: regulatory knowledge, protocol interpretation, and systems fluency
2Interpersonal competencies: communication, empathy, and professional boundaries
3Organizational competencies: the systems that keep you afloat
4Self-assessment and honest gap analysis

Module 5: Quality mindset for the CRC

1Quality by design: how E6(R3) changed the quality conversation
2Thinking in terms of Critical to Quality factors at the site level
3Preventing deviations: the CRC as the first line of defense
4When deviations happen: documentation, reporting, and corrective thinking

Module 6: Career pathways and professional development

1The CRC career ladder: from entry-level to senior and lead roles
2Lateral moves: CRA, regulatory affairs, project management, and data management
3Certifications that matter: CCRC, CCRP, and beyond
4Building your professional brand and network

Module 7: Leadership and mentorship

1The Lead CRC role: portfolio management and team oversight
2Training and mentoring new CRCs effectively
3Managing up: influencing investigators, site leadership, and institutional priorities
Module Quiz10 questions

Course 1 Final Exam: The CRC Role -- Foundations and Career Path50 questions · 90 min · 75% to pass · 3 attempts

Study Start-Up and Site Activation

View Course Details

7 modules

28 lessons

Module 1: Protocol receipt and initial review

1Receiving a new protocol: what to look for in the first 48 hours
2Operational protocol review: translating science into site workflow
3Identifying red flags: procedures your site cannot support
4The protocol synopsis as your operational roadmap
Module Quiz10 questions

Module 2: Feasibility assessment

1Patient population assessment: do you actually have these patients?
2Resource and infrastructure evaluation: staff, space, equipment, and time
3Competing studies and therapeutic area saturation: when your portfolio outgrows your patients
4Completing feasibility questionnaires and confidential disclosure agreements

Module 3: Budgets, contracts, and financial management

1Understanding clinical trial budgets: revenue, cost, and the space between
2Fair market value and anti-kickback considerations
3The contract negotiation process: what CRCs need to know
4Budget tracking and financial reconciliation during the study

Module 4: Regulatory submissions

1The FDA Form 1572: what it means and why it matters
2IRB/IEC initial submission packages: assembling the complete application
3Central IRB vs. local IRB: different processes, same principles
4Regulatory authority notifications and institutional requirements

Module 5: Essential record collection

1The essential records checklist: what you need and when you need it
2Investigator and site staff documentation: CVs, licenses, training records, and delegation logs
3Laboratory documentation: certifications, normal ranges, and accreditation
4Sponsor-provided documents: protocol, IB, IP information, and study-specific materials

Module 6: The site initiation visit

1Preparing for the SIV: logistics, materials, and team readiness
2During the SIV: your role, your questions, and what to document
3Post-SIV action items: turning training into operational readiness
4From SIV to first patient: the final activation checklist

Module 7: Activation and enrollment readiness

1System access and configuration: EDC, IVRS/IWRS, and study portals
2Internal workflows: establishing visit templates, order sets, and lab kits
3Pre-enrollment team readiness checks
4The first enrollment: a walkthrough from identification to randomization

Final Exam: Study Start-Up and Site Activation50 questions · 90 min · 80% to pass · 3 attempts

Informed Consent in Practice

View Course Details

7 modules

28 lessons

The Ethical and Regulatory Foundations of Consent

1From Nuremberg to E6(R3): The Ethical Imperative Behind Informed Consent
2ICH E6(R3) Section 2.8: The Consent Requirements in Full
3The CRC's Role in the Consent Process: Delegation, Scope, and Accountability
4Consent as a Process, Not an Event: The Ongoing Nature of Informed Consent
Module Quiz10 questions

Preparing for the Consent Encounter

1Mastering the Consent Document: Knowing Every Section and Why It Matters
2The Consent Environment: Privacy, Time, and Freedom from Coercion
3Preparing for Common Questions and Concerns
4Cultural and Linguistic Considerations in Consent Preparation

Conducting the Consent Conversation

1Opening the Conversation: Setting Tone and Expectations
2Walking Through the Consent Document: Pacing, Emphasis, and Plain Language
3Addressing Risks, Benefits, and Alternatives Honestly
4The Participant's Questions: Encouraging and Answering Them Well

Assessing and Ensuring Comprehension

1Why 'Do You Have Any Questions?' Is Not Enough
2Teach-Back Methods: Asking Participants to Explain in Their Own Words
3Assessing Comprehension of Key Concepts: Randomization, Placebo, Voluntariness
4When Comprehension Is Inadequate: Next Steps and Ethical Obligations

Special Populations and Consent Challenges

1Pediatric Consent and Assent: Age-Appropriate Communication
2Legally Authorized Representatives: Identifying, Consenting, and Documenting
3Participants with Cognitive Impairment: Assessing Capacity and Protecting Rights
4Short-Form Consent and Consent in Emergency Situations

Reconsent and Ongoing Consent Obligations

1Protocol Amendments That Trigger Reconsent: Identifying Which Changes Matter
2The Reconsent Process: Logistics, Timing, and Participant Communication
3Safety-Driven Reconsent: New Risks, IB Updates, and DSMB Communications
4Ongoing Consent: Keeping Participants Informed Between Formal Reconsent Events

Consent Documentation and Quality

1The Consent Form as a Legal Document: Signatures, Dates, and Required Elements
2Documenting the consent process beyond the signature page
3Consent form storage, access, and participant copies
4Common consent documentation errors and how to prevent them

Final Exam: Informed Consent in Practice50 questions · 75 min · 80% to pass · 3 attempts

Participant Management: Screening to Retention

View Course Details

8 modules

32 lessons

Module 1: Recruitment strategy and ethics

1Building a recruitment plan: channels, timelines, and metrics
2IRB-approved recruitment materials: what you can and cannot say
3Ethical recruitment: the line between motivation and coercion
4Physician referral networks and community outreach
Module Quiz12 questions

Module 2: Pre-screening and eligibility assessment

1Medical record pre-screening: what to look for and HIPAA considerations
2Telephone pre-screening: scripts, scope, and documentation
3Database and registry-based identification strategies
4The pre-screening log: tracking and documenting your funnel

Module 3: The screening visit

1Screening visit workflow: from arrival to departure
2Executing screening procedures per protocol
3Eligibility determination: applying inclusion/exclusion criteria with precision
4Screen failures: documentation, communication, and rescreening decisions

Module 4: Enrollment and randomization

1Enrollment eligibility confirmation and documentation
2Using IVRS/IWRS: randomization and treatment assignment systems
3Enrollment documentation: what must be recorded and where
4Managing enrollment targets and communicating with the sponsor

Module 5: Visit execution and management

1Visit scheduling: windows, conflicts, and participant communication
2Visit preparation: checklists, supplies, and coordination with ancillary departments
3Conducting the study visit: procedure execution and real-time documentation
4Post-visit follow-up: result reviews, participant communication, and next-visit preparation

Module 6: Investigational product accountability

1IP receipt, verification, and storage per ICH E6(R3) Annex 1, Section 2.10
2IP dispensing and participant compliance assessment
3IP reconciliation and accountability logs
4Temperature excursions, expiration, and handling deviations

Module 7: Protocol deviations and CAPA

1Types of deviations: major, minor, and the gray area between
2Identifying deviations in real time vs. retrospective discovery
3Documentation, reporting, and root cause analysis
4Corrective and preventive actions: from quick fixes to systemic improvements

Module 8: Retention, withdrawal, and loss to follow-up

1Retention strategies that respect participant autonomy
2When participants want to withdraw: rights, process, and documentation per ICH E6(R3) Annex 1, Section 2.9
3Participant discontinuation vs. study withdrawal: understanding the distinction
4Lost to follow-up: when and how to stop trying

Final Exam: Participant Management -- Screening to Retention55 questions · 90 min · 80% to pass · 3 attempts

Data Collection and Source Documentation

View Course Details

7 modules

28 lessons

Module 1: Data integrity principles for the CRC

1Data integrity per ICH E6(R3): the eight criteria that govern every data point you create
2ICH E6(R3) data governance: what changed and why it matters (Annex 1, Section 4)
3The consequences of data integrity failures: real cases, real outcomes
4The CRC as the first line of data defense
Module Quiz10 questions

Module 2: Source documentation mastery

1What qualifies as a source document: definitions and examples per ICH E6(R3)
2Designing and using source document worksheets
3The electronic medical record as source: opportunities and pitfalls
4Real-time documentation: why 'I will chart it later' is never acceptable

Module 3: Source-to-CRF workflow

1Understanding the CRF: structure, completion guidelines, and common pitfalls
2Transcription discipline: source to CRF without error
3Self-QC techniques: catching your own mistakes before the monitor does
4Paper CRFs vs. electronic data capture: different systems, same principles

Module 4: Electronic data capture systems

1EDC fundamentals: navigating the interface, entering data, and saving work
2Edit checks and validation rules: understanding what the system is telling you
3Electronic signatures and the meaning of 'sign and lock'
4System access, training documentation, and 21 CFR Part 11 awareness

Module 5: Query management

1Understanding query types: automated edit checks, manual monitor queries, and medical queries
2Resolving queries: investigation, correction, and explanation
3Query resolution timelines and escalation procedures
4Reducing query volume through better initial data entry

Module 6: Data quality and the monitoring interface

1Source data verification: what monitors are checking and why
2Preparing for SDV: organizing source documents for efficient review
3Post-monitoring data corrections and reconciliation
4Remote monitoring and centralized data review: what you need to know

Module 7: Emerging data practices

1ePRO and eCOA: patient-reported outcomes in the digital age
2Wearable devices and sensor data: the CRC's role
3EHR-to-EDC integration: promises and practical realities
4Data governance for emerging technologies: applying ICH E6(R3) Section 4 to new paradigms

Final Exam: Data Collection and Source Documentation50 questions · 90 min · 80% to pass · 3 attempts

Safety Reporting and Pharmacovigilance for CRCs

View Course Details

7 modules

28 lessons

Module 1: Foundations of safety reporting

1Why safety reporting matters: from site reports to regulatory signals
2The regulatory framework: ICH E6(R3) Section 2.7, ICH E2A, and FDA requirements
3The CRC's role in the safety reporting chain
4Definitions that matter: adverse event, serious adverse event, SUSAR, and the distinctions between them
Module Quiz12 questions

Module 2: Adverse event identification

1Eliciting adverse events: open-ended questioning techniques
2Physical assessment and vital sign changes as AE indicators
3Laboratory abnormalities: when a lab value becomes an adverse event
4Between-visit AE identification: phone contacts, participant diaries, and spontaneous reports

Module 3: Adverse event assessment and grading

1Severity grading: CTCAE and protocol-specific grading scales
2Seriousness criteria: the SAE triggers you must know
3Expectedness: the Investigator's Brochure as your reference
4Causality assessment: the investigator's judgment and the CRC's contribution

Module 4: Adverse event documentation

1The AE source document: what to capture and how to capture it
2AE CRF completion: onset, resolution, severity, action taken, and outcome
3Narrative descriptions that tell the clinical story
4Concomitant medication documentation in the context of safety reporting

Module 5: Serious adverse event reporting

1Recognizing an SAE: the moment awareness triggers the clock
2Initial SAE reporting: the 24-hour timeline and what the initial report must contain
3SAE follow-up reports: updates, resolution, and final outcomes
4SAE reporting for different scenarios: hospitalizations, deaths, and pregnancy

Module 6: Safety communications and ongoing vigilance

1Investigator's Brochure updates: what changed and what it means for your site
2Sponsor safety letters and CIOMS/MedWatch reports
3DSMB and DMC communications: when the data monitoring committee speaks
4IRB/IEC reporting of safety information: meeting your institutional obligations

Module 7: Building a safety culture at your site

1Safety reporting training for the site team: what everyone needs to know
2Safety reporting systems: tracking, reminders, and quality checks
3Learning from safety events: using AE patterns to improve participant care
4The intersection of safety reporting and quality management

Final Exam: Safety Reporting and Pharmacovigilance for CRCs50 questions · 90 min · 80% to pass · 3 attempts

Monitoring, Close-Out & the Modern CRC

View Course Details

8 modules

32 lessons

Module 1: Understanding monitoring in the E6(R3) era

1The evolution of monitoring: from 100% SDV to risk-based approaches
2ICH E6(R3) monitoring framework: Annex 1, Section 3.11.4 in practice
3Types of monitoring: on-site, remote, centralized, and how they affect your work
4The monitoring plan: what sponsors and CROs are looking for and why
Module Quiz12 questions

Module 2: Preparing for monitoring visits

1Ongoing monitoring readiness: the weekly and monthly routines
2Pre-visit preparation: the two-week and two-day checklists
3Organizing source documents for efficient SDV
4Preparing participant charts and regulatory binders

Module 3: During the monitoring visit

1The monitoring visit day: logistics, workspace, and communication
2Supporting the monitor: what to provide, when to be available, and what to expect
3Handling difficult conversations: findings, disagreements, and escalation
4Same-day resolution: addressing issues while the monitor is still on-site

Module 4: Responding to findings and follow-up

1Reading and responding to monitoring visit reports
2Implementing corrective actions: timelines, documentation, and verification
3CAPA for monitoring findings: when is a pattern a systemic issue?
4Using monitoring feedback to improve site operations

Module 5: Audits and inspections

1Types of inspections: FDA, EMA, sponsor, and the differences that matter
2Preparing for a regulatory inspection: what to expect and how to ready your site
3During the inspection: your conduct, your rights, and your responsibilities
4Post-inspection: responding to FDA 483 observations and audit findings

Module 6: Study close-out

1Planning for close-out: starting preparation before the last patient last visit
2Final participant activities: end-of-study visits, transition to standard care, and unblinding
3Document reconciliation: closing every loop in the binder, CRF, and query log
4IP reconciliation, return, and destruction documentation

Module 7: Archiving and record retention

1Retention requirements: ICH, FDA, and institutional obligations
2Preparing documents for archiving: organization, indexing, and physical preparation
3Electronic records archiving and long-term accessibility
4The close-out monitoring visit and final regulatory notifications

Module 8: The modern CRC -- emerging practices and leadership

1eConsent: electronic consent systems, regulatory requirements, and participant experience
2Decentralized and hybrid trial designs: the CRC's evolving role
3Risk-based quality management in daily CRC practice
4CRC leadership in the evolving clinical trial landscape

Final Exam: Monitoring, Close-Out & the Modern CRC55 questions · 75 min · 75% to pass · 3 attempts

Clinical Research Coordinator

8 courses in this track

The CRC Role: Foundations and Career Path

Have an invitation code?

Clinical Research Coordinator

8 courses in this track

The CRC Role: Foundations and Career Path

Have an invitation code?

Module 1: The CRC in the clinical trial ecosystem

Module 2: Your professional relationships

Module 3: A day in the life -- operational realities

Module 4: Core competencies and self-assessment

Module 5: Quality mindset for the CRC

Module 6: Career pathways and professional development

Module 7: Leadership and mentorship

Study Start-Up and Site Activation

Module 1: Protocol receipt and initial review

Module 2: Feasibility assessment

Module 3: Budgets, contracts, and financial management

Module 4: Regulatory submissions

Module 5: Essential record collection

Module 6: The site initiation visit

Module 7: Activation and enrollment readiness

Essential Records and the Trial Master File

Module 1: The regulatory foundation for essential records

Module 2: Regulatory binder architecture

Module 3: Pre-study and study initiation documents

Module 4: Documents during the conduct of the trial

Module 5: Version control and document lifecycle management

Module 6: Inspection readiness and binder maintenance

Informed Consent in Practice

The Ethical and Regulatory Foundations of Consent

Preparing for the Consent Encounter

Conducting the Consent Conversation

Assessing and Ensuring Comprehension

Special Populations and Consent Challenges

Reconsent and Ongoing Consent Obligations

Consent Documentation and Quality

Participant Management: Screening to Retention

Module 1: Recruitment strategy and ethics

Module 2: Pre-screening and eligibility assessment

Module 3: The screening visit

Module 4: Enrollment and randomization

Module 5: Visit execution and management

Module 6: Investigational product accountability

Module 7: Protocol deviations and CAPA

Module 8: Retention, withdrawal, and loss to follow-up

Data Collection and Source Documentation

Module 1: Data integrity principles for the CRC

Module 2: Source documentation mastery

Module 3: Source-to-CRF workflow

Module 4: Electronic data capture systems

Module 5: Query management

Module 6: Data quality and the monitoring interface

Module 7: Emerging data practices

Safety Reporting and Pharmacovigilance for CRCs

Module 1: Foundations of safety reporting

Module 2: Adverse event identification

Module 3: Adverse event assessment and grading

Module 4: Adverse event documentation

Module 5: Serious adverse event reporting

Module 6: Safety communications and ongoing vigilance

Module 7: Building a safety culture at your site

Monitoring, Close-Out & the Modern CRC

Module 1: Understanding monitoring in the E6(R3) era

Module 2: Preparing for monitoring visits

Module 3: During the monitoring visit

Module 4: Responding to findings and follow-up

Module 5: Audits and inspections

Module 6: Study close-out

Module 7: Archiving and record retention

Module 8: The modern CRC -- emerging practices and leadership

Module 1: The CRC in the clinical trial ecosystem

Module 2: Your professional relationships

Module 3: A day in the life -- operational realities

Module 4: Core competencies and self-assessment

Module 5: Quality mindset for the CRC

Module 6: Career pathways and professional development

Module 7: Leadership and mentorship

Study Start-Up and Site Activation