ICH E6(R3) Annex 1 Site Kit 06, Investigational Product and Blinding — 11 records across 2 procedures

E6(R3) Site Kit 06 — Investigational Product & Blinding

$249.00
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ICH E6(R3) Annex 1 Site Kit 06, Investigational Product and Blinding — 11 records across 2 procedures

E6(R3) Site Kit 06 — Investigational Product & Blinding

$249.00

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Getting the product accounted for at site, and keeping the blind intact until it is meant to break.

2 procedures, 11 records. Answers 14 site-facing E6(R3) expectations, 3 new in R3 and 5 scored critical.

  • Investigational product management at the investigator site
  • Randomisation, blinding and emergency unblinding

The emergency unblinding record is the document people wish they had after the fact rather than before.

Word and Excel, editable, no macros. Individual Licence.

Pairs well with