Introduction: Dual Medical Monitor + Medical Science Liaison Training Overview, CME Handout, Live Review Webinar |
Orient to dual‐role program structure and live‐session logistics; establish learning objectives and certification requirements. |
CH 1. Wk 1 ICH GCP: Introduction to Clinical Research, What is ICH GCP, Code of Federal Regulations, CFR 21 Part 11, Sponsor/CRO Responsibilities, 13 Principles (IRB & Investigator Roles), Informed Consent, Safety of Human Subjects, Reporting Responsibilities, Adverse Events, Ethics (Children, Mentally Incapacitated, Pregnant Women & Fetuses, Prisoners), Trial Management (Data Handling & Retention), Common Terminology, Common Abbreviations, ICH GCP Quiz |
Master GCP principles, regulatory compliance (CFR 21), ethical safeguards, AE reporting, and data retention best practices; validate knowledge via quiz. |
CH 2. Wk 1 Quality Monitoring (45 modules): Duties & Responsibilities of CRA/Medical Monitor; Advanced Trial Designs; Review of Phases (Preclinical–Phase IV); Stakeholders in Trials; CRO Delegation & Management; RCT Methods; Monitoring Visit Types; Site/Investigator Selection Criteria; SSV/SQV Procedures; SIV Procedures; RMV/IMV/PMV Procedures; Source Documents & ICFs; Inclusion/Exclusion Criteria; Interactive Response Technologies; Protocol Mastery; Protocol Deviations & Violations; Institutional Review Board; Quality Control (QC/QA, KQI, QMS); Pharmacovigilance (Parts 1 & 2); Local & Central Labs |
Develop end‑to‑end monitoring oversight, from visit planning (SSV, SIV, RMV) to QC/QMS audits; implement SDV, ICF checklists, deviations/CAPA processes; integrate PV workflows and lab audits. |
CH 3. Wk 1 Regulatory Training (15 modules): Regulatory Documents; Regulatory Affairs; Essential Documents & Binder Tabs (Parts 1 & 2); Electronic Submission & Review; Financial Disclosures & COI; FDA Form 1572 (Parts 1 & 2); DOAL; Investigator’s Brochures; Protocol Continuing; IND Application; TMF & DIA Model; TMF Reference Guide; Regulatory Training Quiz |
Compile and maintain regulatory binders, e‑submissions, financial‑disclosure logs, Form 1572, DOAL, TMF per DIA standards; assess proficiency via quiz. |
CH 4. Wk 1 Audit & Inspections (5): Audits & Inspections; FDA Warning Letter; Surviving an FDA Inspection; Audits & Inspection Quiz |
Conduct mock audits and BIMO reviews; prepare inspection‑ready documentation and CAPAs; validate through quiz. |
CH 5. Wk 1 Recruitment, Retention & Compliance (5): Compliance Requirements; Subject Recruitment & Retention (Parts 1 & 2); Increasing Compliance; Ethical Considerations (Investigator Payment & Recruitment) |
Design ethical recruitment/retention strategies; implement adherence protocols; manage incentives within compliance frameworks. |
CH 6. Wk 1 Misconduct & Fraud (2): Scientific Misconduct Prevention; Detecting Falsification |
Apply forensic audit techniques; institute controls for research integrity. |
CH 7. Wk 2 Quality Monitoring Reports & Follow‑Up (16): Site Monitor Transition Letter; Pre‑Study Checklist; Assessment Questionnaire; Qualification Assessment; Follow‑Up Letter; SIV Agenda, Confirmation, Report; Monitoring Visit Confirmation, Report, Follow‑Up; SCOV Confirmation, Agenda, Report, Follow‑Up; REFERENCE Module |
Draft comprehensive visit deliverables; use standardized templates for pre‑study, initiation, monitoring, and close‑out; maintain version control. |
CH 8. Wk 2 Foundations of Medical Monitoring: Advanced Monitoring & Cross‑Functional Collaboration; Primary vs. Advanced Monitoring; Ethical & Certification Goals; ICH‑GCP & Regional Guidelines; Sponsor/Investigator/IRB Responsibilities; Legal/Ethical Standards & CFR 21 Part 11 |
Distinguish MSL vs. monitor roles; coordinate global teams; uphold compliance in advanced monitoring. |
CH 9. Wk 2 Trial Phases & Procedures: Monitoring Procedures (Phases 0–IV); Translational‑Research Challenges; Safety Compliance; Protocol‑Specific Monitoring & Case Studies; Pediatric & Vulnerable‑Population Monitoring |
Design phase‑appropriate monitoring; mitigate translational risks; ensure pediatric/vulnerable safeguards. |
CH 10. Wk 2 Monitoring Techniques & Tools: Developing Risk‑Based Plans; Adaptive Monitoring & Predictive Analytics; SDV & Review Tools; Centralized & On‑Site Monitoring; Feasibility Assessment |
Construct risk‑based monitoring with adaptive triggers; apply analytics; conduct centralized and on‑site visits. |
CH 11. Wk 2 Investigator & Site Management: Qualification & Training; Protocol Adherence; Managing Non‑Compliance & CAPAs; Site Initiation, Maintenance & Closure Oversight |
Qualify and train investigators; implement CAPAs; manage site life‐cycle activities. |
CH 12. Wk 2 Data Management & Risk Assessment: Ensuring Data Accuracy & Reliability; Missing Data Handling; Centralized & On‑Site Monitoring; Risk Plans & Statistical Tools; High‑Risk Site Identification |
Establish data‑management SOPs; apply statistical risk tools; reshape monitoring based on risk profiles. |
CH 13. Wk 3 Specialized Monitoring Areas: Oncology Trials; Rare‑Disease Trials; Device & Drug Trials; Multi‑National Coordination |
Tailor monitoring to therapeutic and regional complexities; manage cross‑border logistics. |
CH 14. Wk 3 Safety & Signal Management: AE Reporting & Detection Tools; Signal Management; Safety Communication; Proactive Risk Mitigation |
Deploy signal detection and dashboards; communicate safety outcomes; implement mitigation workflows. |
CH 15. Wk 3 Technology & Innovation: Reporting Dashboards; Digital Error Detection; A/B Split Testing; Sequential Techniques |
Build interactive dashboards; apply error‑detection; design monitoring experiments. |
CH 16. Wk 3 Leadership & Team Management: Cross‑Functional Team Leadership; Decision Making; Sponsor Negotiations; Stakeholder Engagement |
Lead multidisciplinary teams; negotiate agreements; align stakeholder needs. |
CH 17. Wk 3 Applications & Certification: Real‑World Simulations; Case‑Study Analyses; Senior Monitor Exam |
Execute simulations; analyze cases; prepare for certification exam. |
CH 18. Wk 3 Advanced Data & PM: Advanced Data Management; Budgeting; Regulatory Submissions; PV Strategies; Crisis Management; Biostatistics; Cross‑Cultural PM |
Integrate biostatistics; manage budgets and crisis response; coordinate international teams. |
CH 19. Wk 4 Advanced Monitoring Strategies: Advanced Recruitment & Site Management; Advanced Protocol & Risk Assessment; Compliance Monitoring & Investigator Training; Monitoring Technologies & Data Analysis; Safety Monitoring & Ethics; Trial Design & Implementation |
Synthesize advanced recruitment/monitoring; train on compliance; integrate new technologies in trial design. |
CH 20. Wk 4 Specialized Techniques: Digital Health; Biologics; Gene‑Therapy; Vaccine; Rare Disease; Pediatric; Oncology; Cardiovascular; Neurology; Infectious Disease; Endocrinology; Gastroenterology; Dermatology; Respiratory; Ophthalmology; Rheumatology; Urology; Nephrology; Hematology; Psychiatry; Women’s Health; Men’s Health; Geriatric; Genetic; Nutritional; Lifestyle; Behavioral; Surgical; Device & Combination; Adaptive; Basket; Umbrella; Platform; Pragmatic; Observational; Registry; Expanded Access; Compassionate Use; Investigator‑Initiated; Industry; Government; Academic; Multicenter; Single‑Center |
Adapt monitoring SOPs to a full spectrum of trial modalities and geographies; manage specialized regulatory and logistical nuances. |
CH 21. Wk 4 Phase‑Specific Monitoring: Phases 0–IV Trials; Post‑Marketing Trials |
Implement phase‑specific compliance and surveillance checklists; track post‑marketing metrics. |
CH 22. Wk 4 Pharmacokinetics & Dynamics: PK/PD Trials; Bioequivalence & Bioavailability Trials |
Oversee PK/PD sampling, assay validation, and reporting for BE/BA studies. |
CH 23. Wk 4 Drug Interaction Monitoring: Drug‑Drug; Drug‑Food; Drug‑Alcohol; Drug‑Tobacco; Drug‑Caffeine; Drug‑Herb; Drug‑Supplement; Drug‑Disease; Drug‑Genotype; Drug‑Phenotype; Drug‑Environment; Drug‑Lifestyle; Drug‑Behavior; Drug‑Compliance; Drug‑Adherence; Drug‑Persistence; Drug‑Discontinuation; Drug‑Switching; Drug‑Substitution; Drug‑Combination; Drug‑Sequence; Drug‑Dose; Drug‑Route; Drug‑Formulation; Drug‑Release; Drug‑Absorption; Drug‑Distribution; Drug‑Metabolism; Drug‑Receptor; Drug‑Enzyme; Drug‑Ion Channel; Drug‑Transporter; Drug‑Protein; Drug‑DNA; Drug‑Organism; Drug‑Population; Drug‑Organ; Drug‑System; Drug‑Community; Drug‑Ecosystem |
Design comprehensive interaction‑study monitoring protocols; coordinate complex sampling designs; analyze and report interaction data. |
CH 24. Wk 4 Conceptual & Theoretical Monitoring: Drug‑Universe; Drug‑Multiverse; Drug‑Dimension; Drug‑Reality; Drug‑Existence; Drug‑Nonexistence; Drug‑Being; Drug‑Nonbeing; Drug‑Entity; Drug‑Nonentity; Drug‑Phenomenon; Drug‑Concept; Drug‑Perception; Drug‑Experience; Drug‑Observation; Drug‑Measurement; Drug‑Analysis; Drug‑Interpretation; Drug‑Understanding; Drug‑Knowledge; Drug‑Wisdom; Drug‑Insight; Drug‑Intuition; Drug‑Reason; Drug‑Logic; Drug‑Rationality; Drug‑Emotion; Drug‑Feeling; Drug‑Sensation; Drug‑Thought; Drug‑Idea; Drug‑Conceptualization; Drug‑Visualization; Drug‑Imagination; Drug‑Creativity; Drug‑Innovation; Drug‑Invention; Drug‑Discovery; Drug‑Exploration; Drug‑Investigation; Drug‑Research; Drug‑Development; Drug‑Testing; Drug‑Evaluation; Drug‑Validation; Drug‑Verification; Drug‑Confirmation; Drug‑Authentication; Drug‑Accreditation; Drug‑Certification; Drug‑Approval; Drug‑Authorization; Drug‑Permission; Drug‑Consent; Drug‑Agreement; Drug‑Contract; Drug‑Commitment; Drug‑Obligation; Drug‑Responsibility; Drug‑Duty; Drug‑Task; Drug‑Function; Drug‑Role; Drug‑Position; Drug‑Status; Drug‑Condition; Drug‑Situation; Drug‑Circumstance; Drug‑Context; Drug‑Environment; Drug‑Setting; Drug‑Background; Drug‑Framework; Drug‑Structure; Drug‑System; Drug‑Network; Drug‑Grid; Drug‑Matrix; Drug‑Array; Drug‑Sequence; Drug‑Series; Drug‑Chain; Drug‑Process; Drug‑Procedure; Drug‑Method; Drug‑Technique; Drug‑Approach; Drug‑Strategy |
Explore philosophical frameworks underlying monitoring; translate abstract concepts into structured trial methodologies; develop strategic, innovative monitoring approaches. |
Strategic Foundations of the Modern MSL Role: Strategic Role Across Lifecycle; Field vs. HQ Affairs; Scientific Exchange vs. Promotion; MSL Contribution to Strategy & Tactics; Cross‑Functional Alignment; Labeling & Indications; KOL Strategy |
Define MSL strategic positioning; maintain compliance in scientific exchange; leverage insights for pipeline and launch decisions. |
Advanced Scientific Fluency & Data Interpretation: Protocol Mastery; Interpreting P‑Values, CI, Subgroup & Forest Plots; Post Hoc Analysis Discussion; RCT vs. RWE Communication; Regulatory Milestones; Pipeline & Competitive Intelligence; MOA & Resistance; Biomarkers & Companion Diagnostics; PK/PD Essentials; Global Guidelines |
Read and present complex clinical data; contextualize RCT vs. RWE; translate regulatory milestones; apply guideline variations in field messaging. |
Thought Leader & KOL Engagement Excellence: KOL Mapping & Segmentation; Pre‑Engagement Planning; Scientific Dialogue Framing; Messaging Adaptation; Managing Data Gaps; Insight Capture; Handling Off‑Label Questions; Advisory Board Facilitation; Building Trust; Global KOL Strategy |
Develop and execute high‑value KOL engagement plans; conduct compliant scientific exchanges; capture and operationalize insights. |
Scientific Communication, Presentation & Messaging: Storytelling; Slide‑Deck Design; Simplifying Science; Handling Conflicting Data; Med‑Info Responses; Journal Clubs; Scientific Writing; Literature Translation; Non‑KOL Messaging; Slide‑Deck Simulation |
Craft compelling narratives; design impactful slide decks; facilitate and respond to scientific dialogues with integrity. |
Medical Affairs Operations & Field Effectiveness: Territory Strategy; Field Activity Planning; CRM (Veeva, MedPro, Salesforce); Insight Capture; Congress Planning & Execution; Post‑Congress Reporting; Launch Playbooks; IIS Support; HEOR & Access Collaboration |
Optimize territory and event planning; document and escalate insights; execute medical‑affairs launch activities; support investigator‑initiated studies. |
Compliance, Ethics & Field Risk Navigation: PhRMA/EFPIA/IFPMA Codes; Field Compliance Do’s/Don’ts; Off‑Label Inquiry Handling; AE Escalation; Ethical Scenarios; Resistance Tactics; Financial Disclosures; Engagement Documentation Protocols |
Adhere to global codes; navigate commercial and ethical challenges; manage AE escalations; document field engagements compliantly. |
Internal Collaboration & Scientific Leadership: MSL Contributions to Medical Plans; HQ Team Collaboration; Escalation Frameworks; Data‑Generation Strategy; Internal Trainings; Scientific Visibility; Messaging Strategy |
Integrate MSL insights into plans; foster HQ collaboration; lead training programs; develop core messaging frameworks. |
Therapeutic Area Mastery Labs: Oncology (Immuno‑Oncology, Tumor Types, MOA, Pathways, Design Nuances); Rare Disease (Framing, Advocacy, Access, Sensitivity) |
Deep‑dive into disease‑area science; apply specialized knowledge in KOL dialogue and protocol support. |
Capstone Simulation: MSL Simulation (Pre‑Call Planning, Exchange, Insight Capture, Escalation & CRM) |
Execute a full MSL field interaction under realistic high‑stakes conditions; demonstrate integration of scientific, strategic, and compliance skills. |
Final Examination: Medical Science Liaison & Monitor Competency Exam |
Validate mastery of AMSLC™ curriculum via rigorous competency assessment; ensure readiness for dual‐role certification. |