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- 1.5.2.4 Principal investigators and study directors
- 1.5.2.5 Research team
- 1.5.2.6 Supporting team
- 1.5.2.7 Quality professionals
- 1.5.2 Roles and responsibilities of involved personnel and organization
- 1.5.3.1 Personnel
- 1.5.3.2 Facilities
- 1.5.3.3 Laboratory and experimental equipment used for measurement
- 1.5.3.4 Electronic information system
- 1.5.3.5 Organization-specific know how
- 1.5.3.6 Documentation requirement for sample and material
- 1.5.3.7 Retained personnel records
- 1.5.3 Management of resources
- 1.5.4.1 Independence of internal compliance assessment
- 1.5.4.2 Internal assessment of the organizations' quality professionals
- 1.5.4 Prevention of Conflict of Interest
- 1.5.5 Sustainability
- 2.1.10 Plausibility check
- 2.1.11 Preregistration
- 2.1.1 Study protocol