Built on the same document
Each annual edition is drafted against the same Investigator's Brochure file, so revision history stays continuous across editions.
What's included
What goes into the annual update
- Cumulative safety data pulled across every active protocol under the current IB, not just the study driving the update
- Reference safety information reviewed and revised where the accumulated data changes the expected event profile
- Efficacy and nonclinical sections refreshed with any new findings since the prior edition
- Version and edition history maintained so sites and ethics committees can confirm which IB version is current
- Update distributed and tracked against each site's regulatory deadline for the annual cycle
Safety-current by design
Cumulative safety review pulls in narratives from safety narrative writing, so the reference safety information reflects everything reported to date.
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