Introduction: Research Project Manager Course Overview; CME Handout; Common Terminology Used In Clinical Research – Reference Glossary; Commonly Used Abbreviations and Terms in Clinical Research; Live Review Session – See discussion for next meeting time |
• Orient to course logistics, CME requirements, and live‑session formats ; • Master the foundational glossary of research‑project management and trial‑specific terminology ; • Navigate enrollment policies and support resources efficiently. |
CH 1. Wk 1 ICH GCP: An Overview of ICH GCP; CFR 21 Part 11; Ethics of Research Involving Children; Ethics of Research Involving Mentally Incapacitated; Ethics of Research Involving Pregnant Women and Fetuses |
• Interpret ICH GCP principles and electronic‑records compliance ; • Apply ethical frameworks for vulnerable populations and informed‑consent processes ; • Ensure protocols safeguard human subjects under varied regulatory and ethical guidelines. |
CH 2. Wk 1 Fundamentals of Project Management: Project Management Fundamentals; PMBOK Summary – Mandatory Project Management Review; Clinical Trial Project Management; Importance of Project Management |
• Apply PMBOK methodologies to clinical‑trial contexts ; • Develop project charters, scope statements, and stakeholder registers ; • Articulate the value of structured project management for on‑time, on‑budget delivery. |
CH 3. Wk 1 Roles & Relationships in Clinical Trials: Role of a Project Sponsor; ICH GCP E6 § 5 – Sponsor/CRO Responsibilities; Institutional Review Board/Ethics Committee (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, Reporting); Data Safety Monitoring Board; Stakeholders in Clinical Trials; Contract Research Organizations; ICH GCP E6 § 2–4; ICH GCP E6 § 4 – Investigator Reporting |
• Map governance structures: sponsors, CROs, IRBs, DSMBs, investigators, PMs, CRAs, CRCs ; • Clarify delegation logs and oversight workflows ; • Coordinate safety‑reporting and IRB‑submission procedures per ICH GCP. |
CH 4. Wk 1 Skills of a Project Manager: Essential Skills of a Project Manager; Technical Skills for Project Management; Project Team; Managing a Project Team |
• Cultivate leadership, negotiation, and communication skills ; • Use PM software (Gantt, WBS) to assign tasks and monitor progress ; • Form, motivate, and mentor cross‑functional project teams. |
CH 5. Wk 1 Project Management Documents: Project Management Documents |
• Create and maintain charters, schedules, risk logs, issue registers, change‑request forms, and stakeholder‑communication plans ; • Standardize documentation for transparency and audit readiness. |
CH 6. Wk 1 Regulatory Documents: Regulatory Documents in Clinical Trials; Delegation of Authority Log (DOAL); Investigator’s Brochure (IB) |
• Organize and update regulatory binders: DOAL logs and IB revisions ; • Ensure compliance with ICH, FDA, and EMA documentation standards. |
CH 7. Wk 1 Trial Master File: Essential Regulatory Documents Binder Tab Organization; Trial Master File Reference Guide |
• Structure the TMF per DIA/RCA best practices ; • Implement version control and conduct TMF quality‑checks for inspection readiness. |
CH 8. Wk 1 New Drug Application: IND & NDA Process; Investigator‑Initiated Multi‑Center Trials; IND/IDE AE Reporting; Safety‑Reporting Requirements for Sponsor Investigators of an IND |
• Navigate IND/NDA submission requirements and safety‑annex planning ; • Coordinate AE‑reporting workflows and regulatory‑authority interactions. |
CH 9. Wk 1 Problem Solving in Project Management: Problem Solving as a Project Manager; Project Failures and Statistics; Project Reporting Styles; Avoiding Project Failure |
• Apply root‑cause analysis and Ishikawa diagrams to resolve project issues ; • Interpret failure‑mode statistics ; • Develop clear, actionable status reports and dashboards. |
CH 10. Wk 1 Budgeting for Clinical Trials and Projects: Project Budgeting; Payments and Budgeting for Investigators and Site; Advertisement Aid in Subject Recruitment and Retention |
• Build detailed trial and project budgets ; • Manage site‑payment schedules and investigator fees ; • Optimize recruitment ROI through targeted advertising budgets. |
CH 11. Wk 1 Clinical Trial Design: Advanced Designs of Clinical Trials; Advanced Review of Phases 0–IV; Randomized Controlled Trials; Blinding and Unblinding; The Clinical Trial Protocol – Advanced Mastery Review; Inclusion/Exclusion Criteria; Protocol Deviations and Violations |
• Critique and implement adaptive and complex trial designs ; • Develop randomization, allocation‑concealment, and emergency‑unblinding procedures ; • Draft robust protocols with precise eligibility criteria ; • Manage deviations via corrective‑action plans. |
CH 12. Wk 2 Project Management Scheduling & Tracking: Basics of Project Scheduling; Project Progress Tracking; Project Management Planning Process |
• Create critical‑path Gantt charts ; • Implement earned‑value metrics and schedule‑variance analyses ; • Maintain rolling‑wave plans and resource‑allocation maps. |
CH 13. Wk 2 Project Management Plan: Project Management Planning Process; Closing a Project; Project Delays; Process Mapping; Metric Tracking |
• Author comprehensive PMPs covering scope, schedule, cost, quality, risk, and communication ; • Plan project closure and handover ; • Use process maps and KPI dashboards to mitigate delays. |
CH 14. Wk 2 Duties of a Successful Project Manager: Roles and Responsibilities of a Project Manager; Project Management Success Factors |
• Define PM accountabilities across the project lifecycle ; • Establish critical success factors and performance indicators for quality delivery. |
CH 15. Wk 2 Adverse Events: Advanced Review of Adverse Events |
• Oversee AE capture, grading (CTCAE), and expedited reporting per ICH E2A/E6 ; • Coordinate safety‑signal escalation with clinical and PV teams. |
CH 16. Wk 2 Site Selection & Visits: Types of Monitoring Visits; Site and Investigator Selection Criteria; Site Selection/Qualification Visit (SSV/SQV) |
• Assess site feasibility—staff credentials, infrastructure, regulatory readiness ; • Plan and conduct SSV/SQV with tailored letters, checklists, and reports. |
CH 17. Wk 2 Audit & Inspections: Audits and Inspections in Clinical Trials; Clinical Trial Data Audits; FDA Warning Letter |
• Conduct internal and sponsor‑led audits; • Prepare inspection‑ready documentation; • Draft responses to FDA observations and implement CAPAs. |
CH 18. Wk 2 Quality Control & Safety: Quality Control in Clinical Trials (QC/QA, KQI, QMS, Checklist); ICH GCP – Safety of Human Subjects |
• Implement QMS and KQI monitoring ; • Drive continuous‑improvement CAPAs ; • Ensure human‑subject protections align with ICH GCP. |
CH 19. Wk 2 Technology in Trials: CTMS; ICH GCP – Trial Management, Data Handling, and Record Keeping; Remote Monitoring Overview; Centralized Monitoring; Interactive Response Technologies (IVRS, IWRS, IRT, RTSM) |
• Configure and validate CTMS, EDC, and IRT systems ; • Integrate remote and centralized monitoring platforms; • Adapt workflows post‑COVID‑19 for decentralized trials. |
CH 20. Wk 2 Pharmacovigilance & Regulatory Affairs: Advanced Practice of Pharmacovigilance; Regulatory Affairs for Clinical Trials |
• Coordinate PV signal‑management workflows in parallel with RA submission strategies; • Align trial‑level safety reporting with post‑market requirements. |
CH 21. Wk 2 Investigational Product & Labs: Investigational Product Storage and Dispensing; Investigational Product Accountability; Local and Central Labs (GLP/CLIA, Lab Audit Checklist) |
• Oversee IP chain‑of‑identity, temperature‑control logistics, and accountability reconciliation ; • Audit and qualify lab vendors for sample handling and reporting. |
CH 22. Wk 3 Patient Recruitment, Retention & Compliance: Patient Recruitment Strategies; Patient Engagement and Retention Techniques; Patient Adherence and Compliance Monitoring |
• Design patient‑centric outreach and consent processes; • Implement retention e‑reminders, tele‑visits, and home‑health support; • Analyze adherence data to refine engagement plans. |
CH 23. Wk 3 Project Manager Job Readiness: Project Manager Skills Interview Questions; Interview Questions |
• Prepare for PM roles with behavioral‑ and competency‑based interview practice; • Develop structured responses to technical and situational questions. |
CH 24. Wk 3 Regulatory Frameworks & Ethical Standards: Declaration of Helsinki; ICH E2A (Expedited Reporting); ICH E8 (R1); ICH E11 (R1); Legal Aspects of Clinical Research; Ethical Issues in Global Trials; Data Protection Regulations; Human Subject Protection; Expedited Regulatory Pathways |
• Interpret ethical and regulatory guidances for trial conduct ; • Manage expedited‑reporting submissions; • Ensure GDPR/CCPA and DoH compliance across global sites. |
CH 25. Wk 3 Trial Design & Methodology: Advanced Protocol Design; Adaptive Clinical Trials; Bayesian Statistics; Complex Innovative Designs; Endpoint Selection; Early‑Phase & Late‑Phase Trials; Investigator‑Initiated Trials; Phases I–IV; Observational Studies; Open‑Label Extensions; Synthetic Control Arms; Feasibility Studies |
• Develop innovative protocol frameworks from first‑in‑human to post‑marketing ; • Select and validate composite, surrogate, and patient‑reported endpoints; • Apply Bayesian and adaptive statistical designs; • Plan feasibility assessments and registry‑based studies. |
CH 26. Wk 3 Statistical Principles & Data Management: ICH E9/E9 (R1); Centralized Statistical Monitoring; Advanced Biostatistics; Sample Size Determination; Meta‑Analysis; CDISC Standards; Data Integrity; CDMS; Data Anonymization; Data Integration; Data Mining; Data Privacy & Security; Data Standardization; Data Sharing; Disclosure Requirements; EHR in Research; Electronic Consent; eTMF; Audit Trail Review |
• Apply statistical‑principles for trial design and analysis ; • Configure CSM and CDMS workflows; • Ensure data‑quality via anonymization, audit trails, and CDISC compliance; • Manage electronic consent and eTMF archives. |
CH 27. Wk 3 Project Management & Operations: Cross‑Functional Team Leadership; PM Software for Trials; Study Start‑Up Optimization; Supply‑Chain Management; Site Relationship Management; Risk‑Based Monitoring; Operational Excellence; Managing Amendments; Multi‑Center Trial Coordination; Study Closeout & Reporting; Protocol Deviations; Quality by Design; QRM; CI; Change Management; Workflow Automation; CRO Selection; CTMS; SOP Development; TMF Management; Site Accreditation; Document Management |
• Lead and coordinate trial operations across global functions ; • Optimize start‑up and supply‑chain logistics ; • Implement RBM and QbD frameworks ; • Automate workflows and select/oversee CRO partners; • Manage SOP and TMF lifecycle; • Accredit sites and standardize document controls. |
CH 28. Wk 3 Patient Engagement & Recruitment: Innovative Recruitment Strategies; Patient‑Centric Trial Design; Diversity & Inclusion; Patient Advocacy; Social‑Media Recruitment; Behavioral‑Science Engagement; Designing Patient‑Friendly Trials; Analyzing Adherence Data |
• Design inclusive, patient‑centric protocols and outreach campaigns ; • Leverage digital and behavioral‑science tactics for recruitment ; • Monitor adherence and engagement metrics to improve retention. |
CH 29. Wk 3 Financial & Risk Management: Financial‑Risk Management; Cost‑Effectiveness Analysis; Budget Impact Analysis; Negotiating Trial Budgets; Developing Clinical Trial Budgets; Cost‑Containment Strategies; Supply‑Chain Risk Management; Economic Modeling; Financial Management |
• Perform financial‑risk assessments and economic‑modeling ; • Develop, negotiate, and control trial budgets; • Implement cost‑containment and supply‑risk mitigation strategies. |
CH 30. Wk 3 Specialized Trial Types & Populations: Drug‑Device Combination Trials; Rare Disease Trials; Oncology Trials; Biosimilars Trials; Investigator‑Initiated Trials; Medical Device Trials; Pediatrics; Rare Diseases; Vulnerable Populations; Hybrid Trials; Gene‑Therapy Trials; Genomic Trials; Pharmacogenomics; PK/PD; Translational Research; Therapeutic‑Area Specialization |
• Adapt project‑management frameworks to specialized modalities and populations ; • Address regulatory, logistical, and ethical nuances for each trial type; • Ensure safety and data‑integrity in high‑complexity studies. |
CH 31. Wk 3 Quality Assurance & Compliance: Monitoring & Auditing; Data‑Protection Compliance; Transparency; Environmental Monitoring; Regulatory‑Change Impact; Quality by Design; Conflict Resolution; Continuous Improvement |
• Oversee QA‑audit programs and compliance with privacy regulations ; • Implement QbD and QRM; • Resolve team conflicts and drive continuous‑improvement initiatives. |
CH 32. Wk 4 Emerging Trends & Future Directions: Decentralized Clinical Trials; Digital Health Integration; Wearable Technology; Environmental Impact; Future Research Trends; Virtual Trials; mHealth; Telemedicine; Digital Biomarkers; Digital Therapeutics; Blockchain; Cloud Computing; Big‑Data; Real‑World Data; Predictive Analytics; Blockchain for Data Security |
• Integrate cutting‑edge technologies into trial designs ; • Design and manage virtual and decentralized models ; • Leverage blockchain, AI, and RWD for enhanced safety, compliance, and insights. |
CH 33. Wk 4 Career Development & Leadership: Career Growth in Research PM; Cross‑Functional Collaboration; Cultural Competence; Conflict Resolution; Strategic Planning; Regulator Communication; Sponsor‑CRO Management; Collaborative Networks; Human Factors; Health Literacy |
• Plan long‑term career paths in clinical‑project management ; • Cultivate cultural agility and stakeholder engagement ; • Lead strategic communications with regulators and sponsors; • Enhance health‑literacy and team collaboration. |
CH 34. Wk 4 Advanced Topics & Innovations: Adaptive Licensing; Advanced Data Visualization; Advanced Pharmacovigilance; Agile Project Management; Assay Development; Benefit‑Risk Assessment; Bioanalytical Validation; Biobanking; Trial Dashboard Building; Centralized Monitoring; Comparative Effectiveness; Companion Diagnostics; Disease‑Modeling; Endpoint Validation; Epidemiology; Outcomes Evaluation; EBM; External Control Arms; Formulation Development; Functional Genomics; Genomic Data; Health Economics; Outcomes Research; Implementation Science; IP Management; KPIs; Legal Aspects; Market Access; Meta‑Analysis; Regulatory Submissions; Observational Studies; Operational Excellence; PROs; Pharmacoeconomics; Post‑Marketing Surveillance; Inspection Preparation; QRM; Rare‑Disease Trials; Emerging Markets; Regulatory Intelligence; Orphan‑Drug Pathways; Remote Monitoring; Safety‑Signal Detection; Scientific Communication; Site Relationship Management; SaMD Trials; Statistical Programming; Study Closeout; Systematic Reviews; Technology Transfer; HTA; Workflow Automation; CSM; Fraud Detection; FSP Models; Global Regulatory Strategy; Human Factors; Innovative Recruitment; Intellectual Property; IITs; Late‑Phase Trials; Machine Learning Applications |
• Synthesize advanced methodologies across data analytics, licensing, and agile PM ; • Develop interactive dashboards and benefit‑risk assessments ; • Manage cutting‑edge innovations (SaMD, genomics, blockchain) ; • Lead regulatory‑strategy and market‑access initiatives. |
Competency Examination: CRPM Competency Exam |
• Demonstrate comprehensive mastery of clinical‑project management principles, tools, and strategic applications through a rigorous certification assessment. |