ICH E6(R3) Annex 1 Site Kit 09, Data, Source Records and Systems — 15 records across 3 procedures

E6(R3) Site Kit 09 — Data, Source Records & Systems

$369.00
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ICH E6(R3) Annex 1 Site Kit 09, Data, Source Records and Systems — 15 records across 3 procedures

E6(R3) Site Kit 09 — Data, Source Records & Systems

$369.00

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Where E6(R3) changed most for sites, and where most sites have least written down.

3 procedures, 15 records — answering 33 site-facing expectations, 26 of them entirely new in R3 and 6 scored critical. More new ground than any other kit in the suite by a wide margin.

  • Source records, data entry, data review and data endorsement
  • Computerised systems used at the investigator site
  • Decentralised elements and remote trial activities

If you run EDC, eConsent or ePRO and your governance is the sponsor's validation certificate in a folder, this is the gap.

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

Pairs well with