52 Governance & Communication
52.1 Purpose
Governance defines how decisions are made in a clinical trial.
While CRA operations generate information, governance structures determine: - who reviews it, - who decides, - and how actions are authorized.
Effective governance prevents: - unclear accountability, - delayed decisions, - and unmanaged escalation.
52.2 Governance Structures
Typical governance layers include:
| Level | Purpose |
|---|---|
| Study Team | Operational coordination |
| Safety Review Committee | Safety oversight |
| Vendor Governance | CRO / vendor performance |
| Steering Committee | Strategic decisions |
Not all trials require all layers, but every trial requires defined decision pathways.
52.3 Study Team Meetings
Study team meetings typically occur: - weekly or biweekly during conduct
Common agenda: - enrollment status - monitoring progress - safety updates - data quality issues - risk register review
These meetings are the operational heartbeat of the trial.
52.4 RACI Framework
RACI defines roles:
| Role | Meaning |
|---|---|
| R | Responsible (does the work) |
| A | Accountable (owns outcome) |
| C | Consulted |
| I | Informed |
Example: - CRA: Responsible for monitoring - CTM: Accountable for monitoring quality - Safety: Consulted on AE issues - Sponsor: Informed of status
52.5 Decision Logs
All major trial decisions should be documented:
- protocol amendments
- enrollment strategy changes
- vendor replacements
- escalation outcomes
Decision logs provide: - transparency - accountability - audit trail
52.6 Communication as Risk Control
Poor communication is itself a risk.
Governance ensures: - consistent information flow, - documented decisions, - controlled escalation, - and stakeholder alignment.
Communication is not soft skill. It is a control mechanism.