E6(R3) Sponsor Kit 08 — Monitoring
E6(R3) Sponsor Kit 08 — Monitoring
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The written case for monitoring less. A risk-based strategy, a data verification specification that states what gets verified and what does not, and the records that show you followed your own plan.
1 procedure, 5 records — the kit with the most leverage per page.
- Monitoring strategy driven by critical-to-quality factors
- Data verification specification — the document that defines less than 100% SDV
- Monitoring plan, visit and central monitoring reports, and output review
R3 offers relief on monitoring reports rather than new duty. That is exactly why this kit earns its place: monitoring is one of the largest controllable costs in trial conduct, and reduced source data verification is the recognised way to bring it down — but you cannot defend verifying less than everything without a written, risk-driven rationale. These are those documents. Three of its expectations are Critical.
Feeds off the risk register in Kit 01, so buy that one first if you do not have it.
Word and Excel, editable, no macros. Individual Licence.