E6(R3) Sponsor Kit 07 — Safety & Medical Oversight
E6(R3) Sponsor Kit 07 — Safety & Medical Oversight
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The Investigator's Brochure, safety reporting, and having a doctor actually reachable.
3 procedures, 17 records. R3 expects medical personnel readily available to advise on trial-related medical questions (3.4.1) — which means named people and a documented arrangement, not a good intention.
- Investigator's Brochure and reference safety information, with the annual update record
- Safety reporting and immediate hazards, including expedited reporting decisions
- Medical monitoring and committees: charters, minutes, escalation
Seven expectations here are scored Critical. If you have no written medical cover arrangement, this is the kit that closes it.
Word and Excel, editable, no macros. Individual Licence. These are templates, not an approved quality system.