What is it? Why is it important?

The Data Manager (DMan) works in collaboration with the SP-INV to ensure that study data is appropriately collected and managed.

Responsibilities include to:

What do I need to do?

As a SP-INV, establish a requirement profile for a DMan. Among others, a DMan should be able to help you to:

  • Decide on a CDMS which complies with regulatory requirements
  • Support the design of forms, and plan the set-up of the study database (eCRF
  • Support the write up the DMP of your study
  • Allow for the smooth running of your database during study conduct and completion (e.g. train staff, manage personalise access, implement change requests, import and export of study data, archive the study database at the end of the study)


During study conduct the DMan is the main contact person regarding the management of the study database, and the provision of professional support (e.g. access control, system error management)

Where can I get help?

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

External Links

GCDMP – Good Clinical Data Management Practice Guide

CDISC – Provides standards in the clinical research process

ECRIN – see in particular

  • Services / Data Centre Certifications


ICH GCP E6(R2) – see in particular guideline

  • 5.5. Trial Management, data handling, and record-keeping
  • CDISC – Clinical Data Interchange Standard Consortium
  • CDMS – Clinical Data Management System
  • CTU – Clinical Trials Unit
  • DM – Data Management
  • DMan – Data Manager
  • DMP – Data Management Plan
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • ECRIN – European Clinical Research Infrastructure Network
  • GCDMP – Good Clinical Data Management Practice Guide
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • RA – Regulatroy Authorities
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Management ↦ Stakeholders ↦ Data Manager

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 Statistic Methodology
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 Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Concept ↦ Data Management ↦ Stakeholders ↦ Data Manager

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