The data management plan is where you write down how data gets from sites to a locked database: forms, checks, queries, coding, reconciliation, lock and archiving. Here is every section it needs, with what to put in each.
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Purpose, scope and responsibilities
CRF design and completion guidelines
Edit checks and data validation
84 checks in the edit check specification
Query management
Medical coding (MedDRA, WHODrug)
SAE reconciliation
Database lock and unlock
Key points
Template
| # | Section | What to include |
|---|---|---|
| 1 | Purpose, scope and responsibilities | Study, sponsor, CRO and vendor roles; who approves the DMP. |
| 2 | Systems | EDC and other systems used, versions, hosting, validation status. |
| 3 | CRF design and completion guidelines | Form list, standards used (such as CDASH), completion guideline reference. |
| 4 | Database build and user acceptance testing | Build process, test scripts, approval before go-live. |
| 5 | Edit checks and data validation | Reference to the edit check specification; how checks are tested and changed. |
| 6 | Query management | Who raises queries, response timelines, closure rules. |
| 7 | External data | Central lab, ePRO, IRT, imaging: transfer specifications and reconciliation. |
| 8 | Medical coding | Dictionaries and versions (MedDRA, WHODrug), coding conventions, review. |
| 9 | SAE reconciliation | How the clinical database is reconciled with the safety database, and how often. |
| 10 | Data review | Listings, medical review, protocol deviation review. |
| 11 | Source data verification | Link to the monitoring plan; fields in scope. |
| 12 | Database lock and unlock | Pre-lock checklist, approvals, unlock procedure. |
| 13 | Data exports and transfers | Formats, schedules, blinding, recipients. |
| 14 | Access and security | Role assignment, access reviews, account deactivation. |
| 15 | Training | Who is trained on what, and how it is recorded. |
| 16 | Change control | How amendments to forms, checks and the DMP are managed. |
| 17 | Archiving | What is archived, format, retention period. |
| 18 | Appendices | Specifications, contact lists, glossary. |
Writing it well
The most common DMP problem is vagueness: "queries will be managed in the EDC system" tells an inspector nothing. A useful DMP says how: edit checks raise automatic queries at entry; data managers raise manual queries during review; sites answer from the form; queries move from open to answered to closed; a corrected value can close its own auto-query. Each of those statements can be checked against the system and the audit trail.
The same applies to lock. Rather than "the database will be locked after cleaning", describe the steps: status overview reviewed for missing data, all queries closed, coding and SAE reconciliation complete, investigator sign-off, then freeze and lock applied, with unlock requiring a documented reason. See database lock for the pre-lock checklist.
A small single-site academic study does not need the same DMP as a global Phase 3 trial. Scale the detail to the risk, but do not skip sections: a short answer for each is better than a missing one.
What the DMP describes
Capture covers the data management steps a DMP describes: edit checks with auto-queries, manual queries, SDV per field, freeze and lock with reasons, MedDRA coding, data review listings, and exports with a code and label per field, a data dictionary, an annotated CRF and an export log.
| SUBJ | ECGPERF_CODE | ECGPERF_LABEL |
|---|---|---|
| 01-001 | Y | Yes |
| 01-002 | ND | Not done |
Raise a query, lock a form and export data in the free sandbox.
Before sign-off
Who owns data management, coding, reconciliation and lock.
CRF completion guidelines, edit check specification, coding conventions.
Expected response times and escalation route.
Frequency and who compares the safety and clinical databases.
Open queries, signatures and SDV status required before lock.
Change history and re-approval when the process changes.
A document describing how trial data will be collected, validated, cleaned, coded, reconciled, locked and archived, and who is responsible for each step.
Before first participant in, then maintained through amendments and finalised at database lock.
Usually the sponsor's or CRO's lead data manager, with approval from the sponsor.
Usually the DMP references a separate edit check specification rather than listing every check.
The section list on this page is a complete outline you can use as a starting point.
Keep exploring
Clinical data management software
The workflows a DMP describes.
Edit checks software
Writing the edit check specification.
Database lock
The pre-lock checklist.
Protocol template
The document the DMP supports.
Delegation log template
Who is authorised to do what.
FDA inspection checklist
What inspectors check.
Queries, lock and exports in one place. Free sandbox.