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:

  • Support the write up of the DMP outlining how data will be collected, documented, stored, shared and preserved
  • Design the study eCRF including its metadata specifications
  • Train staff on eCRF data entry including applicable rights and access control
  • Put the database into operation and ensure it remains fully operational during study conduct (e.g. guaranteed 24/7 access / if applicable, crucial for participant randomisation)
  • Perform CRF change requests from the SP-INV. Changes to the study CRF might require a protocol amendment approved by EC/ if applicable RA (e.g. Swissmedic)
  • Support data quality checks during study conduct (e.g. central monitoring)
  • Support and implement data exports
  • Implement randomisation processes including blinding/unblinding procedures
  • Manage the CDMS updates and perform applicable electronic system validations
  • Locks and archives the study database at the end of the study

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, and who can perform its initial installation and validation, including server maintenance
  • Support the selection of variables needed to answer your study questions, and plan the set-up of the study database (eCRF
  • Write up the Data Management Plan (DMP) of your study
  • Implement CDMS updates during study conduct
  • Guarantee the smooth running of your database during study conduct and completion (e.g. train staff on data entry, 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. study staff, SP-INV, Site-INV, statistician, study monitor, applicable partners)


The following sites might be helpful:

  • GCDMP: Provides a reference to clinical data managers in their implementation of high quality clinical data


  • CDISC: Provides standards in the clinical research process. It is geared towards establishing clinical data standards to ensure data remains valuable and relevant. Having common data standards greatly facilitates data sharing, essential with the aim to further clinical research


  • ECRIN: Provides data certification standards intended to describe good practice in data and IT management in clinical research. They also conduct audits and issue respective certifications

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

  • Data certification standards


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
  • 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
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Handling ↦ 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 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): Concept ↦ Data Handling ↦ Stakeholders ↦ Data Manager

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