Syllabus
CIDSP Prep Course (CIDSP)
81 lessons. Online and self-paced.
Regulatory Foundations
Core regulations, Good Clinical Practice principles, and role boundaries that govern IDS activity across study start-up and conduct.
- 1ICH GCP E6(R3) Principles
- 2Key FDA Regulatory Parts
- 3Sponsor Investigator IRB Roles
- 4Trial Registration Basics
- 5Investigator Initiated IND Support
- 6Unanticipated Problem Escalation
Protocol Feasibility
Pharmacy-centered protocol review, study start-up assessment, and operational translation of protocol requirements into safe IDS workflows.
- 7Medication Section Analysis
- 8Preparation And Dispensing Complexity
- 9Institutional Resource Assessment
- 10Pharmacy Manual Feedback
- 11Pharmacy IRB Submission Content
- 12Medication Language In Consent
- 13Site Initiation Preparation
- 14Contracts And Activation Controls
- 15Study Specific SOP Design
- 16Order Sets And Worksheets
- 17Risk Based Monitoring Plans
- 18High Risk Process Controls
IP Receipt And Inventory
Lifecycle management of investigational product from ordering through storage, resupply, and decentralized logistics.
- 19IP Ordering And Resupply
- 20Receipt Verification Workflow
- 21Quarantine And Release Decisions
- 22Validated Monitoring Systems
- 23Temperature Excursion Management
- 24Import Export Considerations
- 25Direct To Participant Shipping
- 26Remote Cold Chain Oversight
- 27Decentralized Accountability Controls
Preparation And Dispensing
Sterile and nonsterile preparation, advanced therapy handling, labeling, randomization, and blinding operations within IDS scope.
- 28USP Standards In IDS
- 29Compounding QA Double Checks
- 30Stability And Beyond Use
- 31Placebo And Comparator Handling
- 32ATIMP Storage And Identity
- 33ATIMP Thaw And Bedside Workflow
- 34IRT Workflow Basics
- 35Blind Protection Procedures
- 36Emergency Unblinding Controls
- 37Investigational Labeling Requirements
Accountability And Disposition
Drug accountability systems, reconciliation logic, discrepancy investigation, and close-out disposition of investigational product.
- 38Core Accountability Elements
- 39Physical Inventory Reconciliation
- 40Discrepancy Investigation Pathway
- 41Participant Return Handling
- 42Destruction And Return Authorization
- 43Study Closeout Reconciliation
Participant Safety Operations
Medication eligibility review, informed consent support, adherence counseling, and concomitant medication management during active trial conduct.
- 44Medication Eligibility Review
- 45Concomitant Exclusion Risks
- 46Medication Counseling In Consent
- 47Investigational Product Counseling
- 48Teach Back And Adherence Tools
- 49Visit Based Medication Reconciliation
- 50Drug Interaction Management
- 51AE And SAE Recognition
- 52Toxicity Response And Dose Changes
- 53Safety Reporting Collaboration
- 54Diversity And Access Barriers
Documentation And Audit Readiness
Data integrity, trial technology systems, monitoring support, CAPA, DSMB support, and inspection readiness for IDS operations.
- 55ALCOA C Documentation Principles
- 56Pharmacy File And eTMF
- 57EDC CTMS And Query Response
- 58Monitoring Visit Preparation
- 59Hosting Audits And Inspections
- 60CAPA Development And Follow Through
- 61Drug Exposure Data Preparation
- 62DSMB Support Activities
- 63SAE And Accountability Reconciliation
Finance And Expanded Access
Research billing compliance, IDS budgeting, invoicing, and expanded access operational management within pharmacist scope.
- 64Sponsor Versus Insurance Charges
- 65Medicare Coverage Analysis Support
- 66Billing Error Prevention
- 67IDS Fee Schedule Design
- 68Pharmacy Budget Negotiation
- 69Invoice And Milestone Tracking
- 70Expanded Access Categories
- 71Compassionate Use IP Management
- 72Expanded Access Billing And Recovery
Leadership And Improvement
IDS leadership, training, technology, SOP governance, interprofessional collaboration, and advancement of research pharmacy practice.
- 73IDS Technology Assessment
- 74Software Validation And Rollout
- 75Staff And Learner Education
- 76IDS KPIs And QI Methods
- 77Interprofessional Relationship Management
- 78Committee And Oversight Participation
- 79IDS SOP Lifecycle
- 80Controlled Document Management
- 81Research Pharmacy Advancement