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
  • Perform quality and data integrity 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

More

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

What do I need to do?

Select or hire a qualified DMan who can help you:

  • Plan the set-up of the study database including the defintion of required DM tasks applicable to your study
  • Decide on a CDMS which complies with regulatory requirements
  • Design and implement an eCRF able to include all required study variables that have to be collected from participants
  • Provide applicable DM training to local staff and answer related questions

Evaluate whether to outsource DM tasks to professional service providers.

More

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– Guidance tool for clinical data managers for implementation of high-quality clinical data

CDISC – Provides standards in the clinical research process

ECRIN – see in particular

  • Data certification standard – Provides data certifications standards

References

ICH GCP E6(R2) – see in particular guideline

  • 5.5. Trial Management, data handling, and record-keeping
Abbreviations
  • CDISC – Clinical Data Interchange Standard Cosortium
  • 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
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Handling ↦ Stakeholders ↦ Data Manager
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Data Handling ↦ Stakeholders ↦ Data Manager

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