13  Delegation, Training & Qualification

13.1 Why Delegation Matters

Delegation links “who did the work” to “who was trained and qualified to do it.”

13.2 Delegation of Authority (DOA) Checks

• All staff performing trial tasks are on the DOA
• Start/stop dates align with actual activity dates
• Roles/responsibilities match staff qualifications
• PI oversight documented per site practice

13.3 Training Oversight (CRA Practical Set)

• Protocol training (initial + amendments)
• GCP training (current)
• Safety reporting training (site obligations)
• EDC/IRT training (as applicable)
• Lab/manual training (specimen handling; imaging manuals if applicable)

NoteOncology-Specific Considerations

• Specialized administration procedures and toxicity management workflows may require documented training
• Imaging review processes often require documented training or guidance acknowledgments

NoteVaccine Trial Considerations

• Training related to vaccination procedures, specimen collection timing, and protocol-defined visit windows is often critical to endpoint validity.
• Training documentation serves as an important risk control to ensure consistency across high-volume enrollment and follow-up activities.
• Ensure delegation logs accurately reflect staff performing vaccination, safety assessments, and specimen collection activities.