How to write a data management plan (DMP)

The data management plan says who does what with the data, from CRF design to archiving. Write it before the build and keep it current until lock.

Export the annotated eCRF

Interactive tour on demo data. Click through at your own pace, no email asked.

All guides and tours

Inside the demo

See it on your own study

A 30-minute call on your protocol, your sites and the modules you need.

Book a demo

Key takeaways

Write the DMP before the database build and sign it with the sponsor.
Cover every step from CRF design to archiving, with owners and timelines.
Point to the specifications and SOPs, and keep their content in those documents.
Update the DMP with each protocol amendment and keep its version history.

A clinical data management plan (DMP) describes how your study collects, cleans, codes, stores and locks its data, and who is responsible for each step. The data manager writes it before the database build, the sponsor approves it, and inspectors read it to check that the team did what the plan says.

What a DMP contains

Most DMPs follow the same outline: study summary and roles, CRF and database design, user acceptance testing, data entry and edit checks, query management, external data such as lab transfers, medical coding, serious adverse event reconciliation, database lock and archiving. Keep each section short and point to the detailed specification or SOP.

How to write a DMP in 7 steps

Start from a template. Use your organisation's template or a public one, and delete what does not apply to the study.
Name the roles. List the data manager, the sponsor contact, the statistician, the coders and the monitors, and who approves what.
Describe the build and testing. Say how you specify, build and test the eCRF, and who signs the user acceptance test.
Set the cleaning rules. Summarise the edit checks, the review listings, the query process and the target answer times.
Cover coding and reconciliation. Record the dictionary versions, the coding conventions and how you reconcile serious adverse events with the safety database.
Define lock and archiving. Write the lock checklist, who signs it, how an unlock works, and where you archive the data and audit trail, and for how long.
Version it. Update the DMP with each protocol amendment and system change, and keep the history.

Mistakes to avoid

A DMP written after go-live. The plan then reads as a report on what already happened.
Copy-pasted SOPs. Nobody reads a 60-page DMP. Reference the SOPs by name.
No owner per task. Name a role for each step, since "the team" answers no queries.

Where Datacapt fits

Datacapt holds several DMP inputs in the system: the variable list with names, types and code lists, the action behind each edit check, the query history, the medical coding audit trail, and the review, lock and signature steps. You can export the empty eCRF with each variable name printed beside its field for the trial master file.