E6(R3) Sponsor Kit 09 — Data Governance & Systems
$1,595.00
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E6(R3) Sponsor Kit 09 — Data Governance & Systems
$1,595.00
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Where E6(R3) changed most, and where most sponsors have least written down.
2 procedures, 8 records — but they answer 43 of the 157 expectations, 16 of them entirely new and 13 scored Critical. More new ground than any other kit in the suite by a wide margin.
- Data governance across the full lifecycle, with the data flow and metadata records
- Computerised systems and access control, validation and audit trail review
- Database lock as a documented, authorised activity (4.2.6) — new in R3
If you run EDC, eConsent, ePRO or a CTMS and your governance is a vendor's validation certificate in a folder, this is the gap.
Word and Excel, editable, no macros. Individual Licence.