What is it? Why is it important?

The Data Management Plan (DMP) is a formal document that describes how data is handled during study conduct and after the study has been completed.


The aim is to offer long-term perspectives on:

  • How data is documented, collected, derived, and validated
  • How data is preserved with long-term access to data and metadata
  • Data relevance and understanding, including data sharing for future use


DMPs will increasingly standardise data handling practices and allow for the reproducibility of research results.


The ability to openly share research data is the main principle of good scientific practice. This should be defined in the DMP.

Health-related data is sensitive data. Consequently, data protection laws, including ethical and confidentiality issues must be considered when sharing this type of data.

What do I need to do?

As a SP-INV, when writing the DMP ask yourself the following questions:


The DMP should be written:

  • In collaboration with the data manager of your study
  • Prior to study conduct, as it might be required during grant applications (e.g. SNF, regulatory institutions)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

SNF – search text

  • Data Management Plan (DMP) – Guidelines for researchers
  • CTU – Clinical Trials Unit
  • DMP – Data Management Plan
  • SNF – Swiss National Science Foundation
  • SP-INV – Sponsor Investigator
Development ↦ Data Handling ↦ Data Quality ↦ Data Mgmt. Plan

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Data Handling ↦ Data Quality ↦ Data Mgmt. Plan

Please note: the Easy-GCS tool is currently under construction.