ICH E6(R3) Annex 1 Sponsor Kit 11, Close-Out and Disclosure — 9 documents across 2 procedures

E6(R3) Sponsor Kit 11 — Close-Out & Disclosure

$745.00
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ICH E6(R3) Annex 1 Sponsor Kit 11, Close-Out and Disclosure — 9 documents across 2 procedures
  • ICH E6(R3) Annex 1 Sponsor Kit 11, Close-Out and Disclosure — 9 documents across 2 procedures
  • ICH E6(R3) Annex 1 Sponsor Kit 11, Close-Out and Disclosure — 9 documents across 2 procedures
E6(R3) Sponsor Kit 11 — Close-Out & Disclosure

E6(R3) Sponsor Kit 11 — Close-Out & Disclosure

$745.00

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Shutting a study down properly, and publishing what you said you would.

2 procedures, 9 records:

  • Registration and results disclosure, including the clinical study report quality section
  • Close-out and early termination, with the site closure checklist
  • Notification records for premature termination or suspension

Word and Excel, editable, no macros to contradict your IT policy.

Pairs well with