Formal Risk Register Framework
Risk Categories
1. Regulatory Risk
- Ethics delays
- Regulatory inconsistencies
- Consent interpretation differences
- Standardized ethics toolkit
- Early submission planning
- Country coordinator oversight
2. Data Risk
- Incomplete abstraction
- Inconsistent variable definitions
- Loss of follow-up
- Data dictionary standardization
- Structured training
- Monitoring audits
3. Technical Risk
- Server downtime
- Security breach
- Data corruption
- VPS redundancy
- Backup rotation
- Firewall + 2FA
- Activity logging
4. Funding Risk
- Delayed grants
- Insufficient infrastructure funding
- Modular scaling
- Conservative infrastructure spending
- Multi-source funding approach
5. Governance Risk
- Role ambiguity
- Conflict of interest
- Leadership turnover
- Documented charter
- COI declarations
- Succession planning