ICH E6(R3) Annex 1 Sponsor Kit 05, Study Start-Up — 18 documents across 4 procedures

E6(R3) Sponsor Kit 05 — Study Start-Up

$1,045.00
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ICH E6(R3) Annex 1 Sponsor Kit 05, Study Start-Up — 18 documents across 4 procedures
  • ICH E6(R3) Annex 1 Sponsor Kit 05, Study Start-Up — 18 documents across 4 procedures
  • ICH E6(R3) Annex 1 Sponsor Kit 05, Study Start-Up — 18 documents across 4 procedures
E6(R3) Sponsor Kit 05 — Study Start-Up

E6(R3) Sponsor Kit 05 — Study Start-Up

$1,045.00

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Everything between deciding to run the study and opening the first site.

4 procedures, 18 records 

  • Feasibility and site selection, with the nominated service provider record
  • Regulatory and IRB/IEC communication, including the confirmation log
  • Agreements, financing and payments: budget approval, payment schedule, change orders
  • Insurance and indemnity, with the exposure summary and injury claim record

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

Pairs well with