ICH E6(R3) Annex 1 Sponsor Gap Assessment, free Excel tool — 157 sponsor expectations, 32 new, 80 expanded, 51 critical

E6(R3) Sponsor Gap Assessment

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ICH E6(R3) Annex 1 Sponsor Gap Assessment, free Excel tool — 157 sponsor expectations, 32 new, 80 expanded, 51 critical

E6(R3) Sponsor Gap Assessment

$0.00
EditionSponsor

E6(R3) Annex 1 rewrote the job description for sponsors. This workbook tells you how much of it you already do, and what gaps you still have to fill.

One row for every expectation the Principles and Annex 1 place on a sponsor. All 157 — 32 new in R3, 51 critical — noting what was standard, what has been upgraded since R2 and what is completely new.

Set a status, note where the evidence lives. It ranks what to close first.

  • Live dashboard, and an action list that re-ranks itself
  • A print summary for whoever asks how it’s going
  • Every row names the kit that closes that gap

Excel, five tabs, no macros to mess with your IT policy.

Downloads as a zip — right-click and Extract All on Windows, double-click on a Mac.

Running an investigator site rather than a sponsor programme? There is a free Site edition.

Steal our homework — please! Free, and yours to keep.

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