Timelines, consent, disclosure and platform obligations.
Reporting timelines
- Serious AE: 7–15 calendar days (TGA)
- Non-serious AE: 90 calendar days
- Australia: aligned with ICH E2A/E2B(R3)
- AbbVie internal timelines may be shorter
Data & consent
- Respondents informed of mandatory AE reporting
- Data handled per AbbVie privacy policy
- De-identified in Screver where permissible
- Full audit trail maintained per PV SOPs
Survey disclosure
- Welcome page states AE reporting obligation
- Provides direct PV / Medical Info contact
- Cannot substitute survey for formal AE report
- Legal review of disclosure text required
Screver platform
- Flag tagging and timestamp preservation
- Restricted access to flagged responses
- Export capability for PV system ingestion
- Retention policy aligned with TGA requirements