Guided Notes

The Data Management Plan (DMP)

What a DMP contains, who approves it, how it guides the study — data flow, systems, cleaning approach, coding, reconciliation, metrics, lock and archiving — and keeping it current.

Purpose of the DMP

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The DMP is the master document describing how a study's data will be collected, cleaned, managed and locked. It: • aligns sponsor, CRO and vendors on responsibilities and timelines, • proves to auditors that processes were planned and followed, • is approved before first patient in and updated with amendments.