Fields captured at point of detection to satisfy TGA.
Patient / Reporter information
Captured at point of detection
- Reporter type (HCP, patient, carer, other)
- Country / region of reporter
- Contact details (if consent provided)
- Date the report was received
Product & event information
Minimum TGA dataset
- Product or therapy area mentioned
- Full verbatim description of the event
- Suspected seriousness level
- Patient outcome (if known at time of report)
All four reporter and four event fields must be captured to satisfy TGA minimum dataset requirements before forwarding to the PV team. Missing fields trigger a follow-up workflow.