Set once, followed throughout
A clear DMP means the same rules apply whether a query is opened in month one or month twelve, by whichever team member is on shift.
What's included
What the DMP defines before build starts
- CRF completion conventions, units, and coding standards agreed with the sponsor and documented against CDASH-aligned collection structures
- Query issuance, escalation, and resolution timelines, plus who on the study team owns each query type
- Coding conventions for MedDRA and WHODrug, including verbatim-term handling and re-coding triggers
- Reconciliation scope and cadence — SAE, lab, and third-party vendor data — set out before conduct begins
- Database lock criteria and the sign-off chain required to declare data clean
- Version control and amendment procedures so protocol or CRF changes flow through as tracked DMP updates, not informal side agreements
Built alongside the CRF
Drafted in parallel with eCRF/aCRF specification, so the plan and the database never drift apart.
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