From the moment a potential participant is identified to the moment they complete their last study visit, the CRC is the primary point of contact, the operational engine, and often the participant's most trusted connection to the research enterprise. This course covers the full participant lifecycle: recruitment strategy, pre-screening, screening visit execution, enrollment, visit management, investigational product accountability, protocol deviation management, participant retention, and the complex situations that arise when participants want to withdraw or are lost to follow-up. IP accountability is integrated here because it is inseparable from visit execution — you cannot manage participants without managing the products they receive.
32 lessons · 8 quizzes · 13 hours of content
Part of the Clinical Research Coordinator learning track
Explore the complete course structure before you enroll.
4 lessons · 180 min
1.1 Building a recruitment plan: channels, timelines, and metrics
Learn to design structured, multi-channel recruitment plans with defined channels, responsible parties, timelines, and measurable success metrics.
Create your free account to access the complete curriculum and knowledge assessments.
From the moment a potential participant is identified to the moment they complete their last study visit, the CRC is the primary point of contact, the operational engine, and often the participant's most trusted connection to the research enterprise. This course covers the full participant lifecycle: recruitment strategy, pre-screening, screening visit execution, enrollment, visit management, investigational product accountability, protocol deviation management, participant retention, and the complex situations that arise when participants want to withdraw or are lost to follow-up. IP accountability is integrated here because it is inseparable from visit execution — you cannot manage participants without managing the products they receive.
32 lessons · 8 quizzes · 13 hours of content
Part of the Clinical Research Coordinator learning track
Explore the complete course structure before you enroll.
4 lessons · 180 min
1.1 Building a recruitment plan: channels, timelines, and metrics
Learn to design structured, multi-channel recruitment plans with defined channels, responsible parties, timelines, and measurable success metrics.
Create your free account to access the complete curriculum and knowledge assessments.
1.2 IRB-approved recruitment materials: what you can and cannot say
Learn which recruitment materials require IRB approval, how to apply evaluation criteria, and how to avoid common compliance pitfalls including social media challenges.
1.3 Ethical recruitment: the line between motivation and coercion
Distinguish permissible recruitment incentives from undue influence using regulatory frameworks, the compensation spectrum, and decision tools for vulnerable populations.
1.4 Physician referral networks and community outreach
Build sustainable physician referral networks and community partnerships for ethical, effective participant recruitment.
4 lessons · 180 min
2.1 Medical record pre-screening: what to look for and HIPAA considerations
Apply HIPAA preparatory to research provisions and systematic chart review methodology to efficiently identify potentially eligible participants.
2.2 Telephone pre-screening: scripts, scope, and documentation
Develop structured telephone pre-screening scripts, navigate scope boundaries between pre-screening and consent, and handle common caller challenges.
2.3 Database and registry-based identification strategies
Translate eligibility criteria into EHR queries, manage false positives, leverage research registries, and apply data governance principles for population-level participant identification.
2.4 The pre-screening log: tracking and documenting your funnel
Design and maintain a pre-screening log as an essential record, calculate recruitment funnel metrics, and prepare sponsor-ready pipeline reports.
4 lessons · 180 min
3.1 Screening visit workflow: from arrival to departure
Map the complete screening visit workflow, coordinate logistics across departments, verify consent as the gateway step, and adapt in real time when complications arise.
3.2 Executing screening procedures per protocol
Execute screening procedures with protocol precision, apply ALCOA documentation principles, and prevent common procedural deviations during vitals, ECGs, labs, and questionnaires.
3.3 Eligibility determination: applying inclusion/exclusion criteria with precision
Verify eligibility criteria systematically, navigate borderline cases with investigator adjudication, and document determinations with source-referenced evidence.
3.4 Screen failures: documentation, communication, and rescreening decisions
Document screen failures properly, conduct sensitive participant conversations, evaluate rescreening eligibility, and use failure data to improve recruitment targeting.
4 lessons · 180 min
4.1 Enrollment eligibility confirmation and documentation
Verify consent currency, re-confirm eligibility within validity windows, obtain investigator sign-off, and understand the regulatory weight of the enrollment decision.
4.2 Using IVRS/IWRS: randomization and treatment assignment systems
Operate IVRS/IWRS systems for randomization and treatment assignment, handle connectivity failures and errors, maintain blinding integrity, and document every transaction step.
4.3 Enrollment documentation: what must be recorded and where
Complete enrollment documentation across source records, enrollment logs, EDC systems, and sponsor reporting with accuracy and regulatory compliance.
4.4 Managing enrollment targets and communicating with the sponsor
Track enrollment velocity against targets, prepare data-driven sponsor communications, adjust recruitment strategies based on pipeline analysis, and manage enrollment pressure ethically.
4 lessons · 180 min
5.1 Visit scheduling: windows, conflicts, and participant communication
Calculate visit windows, manage scheduling conflicts proactively, communicate with participants about visit requirements, and handle inevitable out-of-window situations.
5.2 Visit preparation: checklists, supplies, and coordination with ancillary departments
Build protocol-specific visit checklists, verify equipment readiness, prepare supplies, coordinate with ancillary departments, and review participant history before each visit.
5.3 Conducting the study visit: procedure execution and real-time documentation
Execute visit procedures in correct sequence, document contemporaneously, manage participant experience, handle visit-day complications, and identify deviations in real time.
5.4 Post-visit follow-up: result reviews, participant communication, and next-visit preparation
Review visit results systematically, communicate findings with investigator guidance, resolve data queries, and prepare for the next visit in the continuous care cycle.
4 lessons · 180 min
6.1 IP receipt, verification, and storage per ICH E6(R3) Annex 1, Section 2.10
Execute investigational product receipt, verification, and storage procedures per ICH E6(R3), establish the IP inventory log, and maintain cold chain integrity.
6.2 IP dispensing and participant compliance assessment
Verify and dispense investigational product correctly, provide clear participant instructions, assess compliance using multiple methods, and manage non-compliance constructively.
6.3 IP reconciliation and accountability logs
Maintain the IP accountability log, perform reconciliation at defined intervals, prepare for monitoring visits, and manage IP return and destruction procedures.
6.4 Temperature excursions, expiration, and handling deviations
Respond to temperature excursions with proper quarantine procedures, manage expiration proactively with FEFO, and classify and document IP handling deviations.
4 lessons · 180 min
7.1 Types of deviations: major, minor, and the gray area between
Define protocol deviations, classify by severity using safety and data integrity criteria, navigate gray areas with CTQ factor analysis, and determine reporting pathways.
7.2 Identifying deviations in real time vs. retrospective discovery
Develop protocol awareness for real-time deviation recognition during visits, implement systematic retrospective review processes, and assess immediate action requirements.
7.3 Documentation, reporting, and root cause analysis
Document deviations with required elements, assess impact on safety and data integrity, conduct root cause analysis using 5-Whys methodology, and submit reports through required channels.
7.4 Corrective and preventive actions: from quick fixes to systemic improvements
Design CAPA plans that target root causes, implement corrective and preventive actions with accountability, and monitor effectiveness to prevent deviation recurrence.
4 lessons · 180 min
8.1 Retention strategies that respect participant autonomy
Implement evidence-based retention strategies addressing specific dropout predictors while maintaining the ethical boundary between supportive participation and undue influence.
8.2 When participants want to withdraw: rights, process, and documentation per ICH E6(R3) Annex 1, Section 2.9
Manage participant withdrawal requests with respect for autonomy per ICH E6(R3) Section 2.9, navigate data retention discussions, and complete all required documentation.
8.3 Participant discontinuation vs. study withdrawal: understanding the distinction
Distinguish intervention discontinuation from study withdrawal and loss to follow-up, apply correct procedures for each status, and understand the data collection implications.
8.4 Lost to follow-up: when and how to stop trying
Document contact attempts systematically, determine when to classify participants as lost to follow-up, navigate the ethical boundary of persistent contact, and manage data quality implications.
1.2 IRB-approved recruitment materials: what you can and cannot say
Learn which recruitment materials require IRB approval, how to apply evaluation criteria, and how to avoid common compliance pitfalls including social media challenges.
1.3 Ethical recruitment: the line between motivation and coercion
Distinguish permissible recruitment incentives from undue influence using regulatory frameworks, the compensation spectrum, and decision tools for vulnerable populations.
1.4 Physician referral networks and community outreach
Build sustainable physician referral networks and community partnerships for ethical, effective participant recruitment.
4 lessons · 180 min
2.1 Medical record pre-screening: what to look for and HIPAA considerations
Apply HIPAA preparatory to research provisions and systematic chart review methodology to efficiently identify potentially eligible participants.
2.2 Telephone pre-screening: scripts, scope, and documentation
Develop structured telephone pre-screening scripts, navigate scope boundaries between pre-screening and consent, and handle common caller challenges.
2.3 Database and registry-based identification strategies
Translate eligibility criteria into EHR queries, manage false positives, leverage research registries, and apply data governance principles for population-level participant identification.
2.4 The pre-screening log: tracking and documenting your funnel
Design and maintain a pre-screening log as an essential record, calculate recruitment funnel metrics, and prepare sponsor-ready pipeline reports.
4 lessons · 180 min
3.1 Screening visit workflow: from arrival to departure
Map the complete screening visit workflow, coordinate logistics across departments, verify consent as the gateway step, and adapt in real time when complications arise.
3.2 Executing screening procedures per protocol
Execute screening procedures with protocol precision, apply ALCOA documentation principles, and prevent common procedural deviations during vitals, ECGs, labs, and questionnaires.
3.3 Eligibility determination: applying inclusion/exclusion criteria with precision
Verify eligibility criteria systematically, navigate borderline cases with investigator adjudication, and document determinations with source-referenced evidence.
3.4 Screen failures: documentation, communication, and rescreening decisions
Document screen failures properly, conduct sensitive participant conversations, evaluate rescreening eligibility, and use failure data to improve recruitment targeting.
4 lessons · 180 min
4.1 Enrollment eligibility confirmation and documentation
Verify consent currency, re-confirm eligibility within validity windows, obtain investigator sign-off, and understand the regulatory weight of the enrollment decision.
4.2 Using IVRS/IWRS: randomization and treatment assignment systems
Operate IVRS/IWRS systems for randomization and treatment assignment, handle connectivity failures and errors, maintain blinding integrity, and document every transaction step.
4.3 Enrollment documentation: what must be recorded and where
Complete enrollment documentation across source records, enrollment logs, EDC systems, and sponsor reporting with accuracy and regulatory compliance.
4.4 Managing enrollment targets and communicating with the sponsor
Track enrollment velocity against targets, prepare data-driven sponsor communications, adjust recruitment strategies based on pipeline analysis, and manage enrollment pressure ethically.
4 lessons · 180 min
5.1 Visit scheduling: windows, conflicts, and participant communication
Calculate visit windows, manage scheduling conflicts proactively, communicate with participants about visit requirements, and handle inevitable out-of-window situations.
5.2 Visit preparation: checklists, supplies, and coordination with ancillary departments
Build protocol-specific visit checklists, verify equipment readiness, prepare supplies, coordinate with ancillary departments, and review participant history before each visit.
5.3 Conducting the study visit: procedure execution and real-time documentation
Execute visit procedures in correct sequence, document contemporaneously, manage participant experience, handle visit-day complications, and identify deviations in real time.
5.4 Post-visit follow-up: result reviews, participant communication, and next-visit preparation
Review visit results systematically, communicate findings with investigator guidance, resolve data queries, and prepare for the next visit in the continuous care cycle.
4 lessons · 180 min
6.1 IP receipt, verification, and storage per ICH E6(R3) Annex 1, Section 2.10
Execute investigational product receipt, verification, and storage procedures per ICH E6(R3), establish the IP inventory log, and maintain cold chain integrity.
6.2 IP dispensing and participant compliance assessment
Verify and dispense investigational product correctly, provide clear participant instructions, assess compliance using multiple methods, and manage non-compliance constructively.
6.3 IP reconciliation and accountability logs
Maintain the IP accountability log, perform reconciliation at defined intervals, prepare for monitoring visits, and manage IP return and destruction procedures.
6.4 Temperature excursions, expiration, and handling deviations
Respond to temperature excursions with proper quarantine procedures, manage expiration proactively with FEFO, and classify and document IP handling deviations.
4 lessons · 180 min
7.1 Types of deviations: major, minor, and the gray area between
Define protocol deviations, classify by severity using safety and data integrity criteria, navigate gray areas with CTQ factor analysis, and determine reporting pathways.
7.2 Identifying deviations in real time vs. retrospective discovery
Develop protocol awareness for real-time deviation recognition during visits, implement systematic retrospective review processes, and assess immediate action requirements.
7.3 Documentation, reporting, and root cause analysis
Document deviations with required elements, assess impact on safety and data integrity, conduct root cause analysis using 5-Whys methodology, and submit reports through required channels.
7.4 Corrective and preventive actions: from quick fixes to systemic improvements
Design CAPA plans that target root causes, implement corrective and preventive actions with accountability, and monitor effectiveness to prevent deviation recurrence.
4 lessons · 180 min
8.1 Retention strategies that respect participant autonomy
Implement evidence-based retention strategies addressing specific dropout predictors while maintaining the ethical boundary between supportive participation and undue influence.
8.2 When participants want to withdraw: rights, process, and documentation per ICH E6(R3) Annex 1, Section 2.9
Manage participant withdrawal requests with respect for autonomy per ICH E6(R3) Section 2.9, navigate data retention discussions, and complete all required documentation.
8.3 Participant discontinuation vs. study withdrawal: understanding the distinction
Distinguish intervention discontinuation from study withdrawal and loss to follow-up, apply correct procedures for each status, and understand the data collection implications.
8.4 Lost to follow-up: when and how to stop trying
Document contact attempts systematically, determine when to classify participants as lost to follow-up, navigate the ethical boundary of persistent contact, and manage data quality implications.