ICH E6(R3) Annex 1 Site Kit 02, Investigator Oversight and Delegation — 8 records across 2 procedures

E6(R3) Site Kit 02 — Investigator Oversight & Delegation

$249.00
Skip to product information
ICH E6(R3) Annex 1 Site Kit 02, Investigator Oversight and Delegation — 8 records across 2 procedures

E6(R3) Site Kit 02 — Investigator Oversight & Delegation

$249.00

Buying from the EU or UK? Register your business first — VAT-registered businesses buy without VAT under the reverse charge. We are not able to sell to private individuals in the EU or UK.

Who the investigator has delegated what to, and the paperwork that proves it was appropriate.

2 procedures, 8 records. Answers 10 site-facing E6(R3) expectations — 5 of them new in R3, and 2 scored critical.

  • Investigator oversight and delegation of trial-related activities
  • Financial disclosure and conflict of interest

Half of what this kit answers has no counterpart in E6(R2). If your delegation log is a signature sheet and nothing else, start here.

Word and Excel, editable, no macros. Individual Licence. These are templates, not an approved quality system.

Pairs well with