E6(R3) Site Kit 10 — Records, ISF & Inspection Readiness
$249.00
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E6(R3) Site Kit 10 — Records, ISF & Inspection Readiness
$249.00
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Being able to find it, prove it was always there, and hand it over when someone asks.
2 procedures, 10 records. Answers 24 site-facing E6(R3) expectations, 7 new in R3 and 6 scored critical.
- Essential records, the Investigator Site File and record retention
- Monitoring, audit and regulatory inspection readiness
One of the quieter new expectations catches everybody: records reachable only through a sponsor's portal still have to end up with the party required to retain them.
Word and Excel, editable, no macros. Individual Licence.