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Welcome and Orientation for Pharmacists

Learning Objectives

Core Principles and Evolution of Investigational Drug Services

History and Evolution of Investigational Drug Services for Pharmacists

Ethical Foundations and Participant Protection in Clinical Trials

Establishing and Managing an IDS Program

Building an IDS Service: Structure, Staffing, and SOPs for Pharmacists

Protocol Intake, Feasibility, and Start-Up Workflow for Pharmacists

Investigational Product (IP) Receipt, Storage, and Chain of Custody

Sterile and Nonsterile Compounding for Investigational Products

Regulatory Compliance and Risk Management

Regulatory Frameworks for Pharmacists in Clinical Trials

Risk Assessment, Safety Reporting, and Quality Assurance

Technology, Data Integrity, and Financial Management

Digital Tools and Data Integrity in IDS Practice

Budgeting, Billing, and Financial Sustainability of IDS

Operational Excellence and Interdisciplinary Collaboration

Day-to-Day IDS Operations and Clinical Interface for Pharmacists

Study Closeout, Returns, and Destruction Processes

Applied Practice: Cases, Tools, and Templates

Interactive Case Studies for Pharmacists: From Start-Up to Closeout

Practical Toolkits: Checklists, Logs, and Communication Templates

Knowledge Checks: Quizzes for Pharmacists

Quiz 1: IDS Foundations and Evolution

Quiz 2: Ethics and Participant Protection

Quiz 3: Building an IDS Program

Quiz 4: Protocol Intake and Start-Up

Quiz 5: IP Receipt and Accountability

Quiz 6: Compounding and Preparation

Quiz 7: Regulatory and GCP Compliance

Quiz 8: Risk Management and Safety Reporting

Quiz 9: Technology and Data Integrity

Quiz 10: Finance and Operations

Closing, Evaluation, and Next Steps for Pharmacists

Action Planning and Professional Development Pathways

Post-Workshop Knowledge Self-Assessment

Workshop Content Relevance and Delivery Feedback

Operational Barriers and Resource Needs Survey

Overall Satisfaction and Recommendations

Investigational Drug Services Foundations: Operations, Technology, Compliance, and Leadership is a comprehensive, practice-ready course designed for pharmacists who support or lead clinical research pharmacy operations. From protocol intake to study closeout, you will learn the systems, standards, and skills required to run a compliant, efficient, and patient-centered IDS. The curriculum blends regulatory frameworks (FDA, ICH E6), ethical principles (Belmont), and day-to-day operational methods with modern technologies such as EMR-integrated workflows, IRT/IWRS, and digital temperature monitoring. You will build confidence in chain-of-custody, blinding integrity, sterile and nonsterile compounding for investigational products, and safety reporting. Beyond technical mastery, the course emphasizes leadership, quality management, risk mitigation, budgeting, and cross-disciplinary communication with investigators, study teams, and sponsors. Interactive cases, practical toolkits, and structured quizzes reinforce learning and translate directly to your site’s SOPs, training, and audit readiness. Whether you are establishing a new IDS or optimizing a mature program, this course equips you to elevate compliance, throughput, and clinical collaboration—while protecting participants and enabling high-quality research outcomes.

Historical perspective, development of IDS

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            <p>Investigational Drug Services Foundations: Operations, Technology, Compliance, and Leadership equips pharmacists to build, manage, and continually improve IDS practice across the clinical trial lifecycle. Rooted in pharmacist competencies, the course blends operational rigor with ethical stewardship, regulatory fluency, and interdisciplinary leadership. You will map milestones in the evolution of IDS to modern workflows, connect Belmont principles to dispensing and counseling realities, and translate Good Clinical Practice into day-to-day accountability, documentation, and audit readiness. From protocol intake and feasibility to study closeout and archiving, each module emphasizes pharmacist roles, decision points, and communication touchpoints with investigators, sponsors, monitors, and clinical teams.</p>

<p>Across the program, you will develop practical capabilities to establish service structure and SOPs, staff and train a high-reliability team, and implement robust quality systems. You will operationalize IP receipt, storage, and chain-of-custody controls; manage sterile and nonsterile compounding aligned with USP standards; and safeguard blinding, randomization interfaces, and data integrity. The technology track covers EMR and IRT/IWRS integration, ALCOA+ and 21 CFR Part 11 expectations, temperature monitoring, and cybersecurity. Financial modules address cost modeling, charge capture, invoicing, and performance metrics to support sustainability and staffing justification. Through interactive cases—such as temperature excursions in a blinded oncology study, complex chain-of-identity for gene therapy, and emergency unblinding—you will practice risk assessment, deviation management, CAPA design, and inspection preparation. Quizzes reinforce learning, while closing modules guide creation of a 90‑day action plan, selection of impact metrics, and pathways for mentorship and professional development.</p>
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