ICH E6(R3) Annex 1 Sponsor Kit 03, Vendor Selection and Oversight — 13 documents across 3 procedures

E6(R3) Sponsor Kit 03 — Vendor Selection & Oversight

$1,395.00
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ICH E6(R3) Annex 1 Sponsor Kit 03, Vendor Selection and Oversight — 13 documents across 3 procedures

E6(R3) Sponsor Kit 03 — Vendor Selection & Oversight

$1,395.00

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Choosing a provider, writing down what they are actually responsible for, and proving you checked.

3 procedures, 13 records. The kit with the most genuinely new ground: six of its expectations have no counterpart in E6(R2) at all, and ten are scored Critical. R3 requires a provider's suitability to be assessed and documented before engagement (3.6.7).

  • Vendor agreements and transfer of obligations
  • Tiered provider suitability assessment and the service provider register
  • Business continuity and system outage fallback

If you use a CRO and have never written down which duties moved and which stayed, start here.

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

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