How Clinical Trials Really Work: Roles, Responsibilities, and Rules

flowchart TD
 A[Protocol and risk-based design] --> B[Site execution and participant interactions]
 B --> C[Data and safety information captured]
 C --> D[Monitoring review and issue detection]
 D --> E[Sponsor oversight and corrective decisions]
 E --> F[Updates to training processes and documentation]
 F --> B
 C --> G[Regulatory and ethics reporting]
 G --> E

flowchart TD
 A[Sponsor governance plan] --> B[CRO study management]
 A --> C[Data management vendor]
 A --> D[Pharmacovigilance vendor]
 B --> E[Issue and metric review]
 C --> E
 D --> E
 E --> F[Escalation and CAPA]
 F --> G[Sponsor documents decisions]

flowchart TD
 A[Protocol duties assigned] --> B[Confirm staff qualification]
 B --> C[Document delegation and training]
 C --> D[Staff perform study tasks]
 D --> E[Investigator reviews safety and conduct]
 E --> F{Issue or drift found?}
 F -->|Yes| G[Retrain, document, escalate]
 F -->|No| H[Continue oversight and review]

flowchart TD
 A[Site or vendor detects issue] --> B[CRO or functional lead triages]
 B --> C{Participant safety or data risk?}
 C -->|Yes| D[Sponsor notified immediately]
 C -->|No| E[Track and correct per plan]
 D --> F[Assign actions, owner, due date]
 E --> F
 F --> G[Monitor effectiveness and closure]

flowchart TD
 A[Participant event identified] --> B[Site assesses seriousness and causality]
 B --> C[Investigator ensures immediate medical oversight]
 C --> D[Site reports SAE per protocol and regulation]
 D --> E[Sponsor or PV vendor reviews case and expectedness]
 E --> F{Reportable to regulators or ethics bodies?}
 F -->|Yes| G[Expedited reporting and follow-up]
 F -->|No| H[Document, track, and trend]
 G --> I[Close loop with site and safety database]
 H --> I[Close loop with site and safety database]