E6(R3) Sponsor Kit 04 — Trial Design & Protocol
$1,045.00
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E6(R3) Sponsor Kit 04 — Trial Design & Protocol
$1,045.00
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Writing a protocol that can be run, and amending it without losing track of who approved what.
2 procedures, 8 records. Four of its expectations are new in R3, including the one people trip over: a system change arising from an amendment reaches a site only once that site's approvals are in place (4.3.5).
- Protocol development, with the cross-functional review record
- Protocol amendments, impact assessment and site-by-site approval tracking
- Design considerations tied back to critical-to-quality factors
Pairs well with Kit 01, which is where the critical-to-quality worksheet lives.
Word and Excel, editable, no macros. Individual Licence.