What is it? Why is it important?

In studies, the purpose of Data Management (DM) is to enable the gathering of high-quality and reliable clinical data, that can subsequently be used for statistical analyses.

Study data must be of high quality as it provides confidence in study results. Credible study results provide an important basis for further research and contributes to the development of future IMPs, MDs, algorithms, etc.

DM sets the framework that ensures that these aims are met.

More

DM includes:

  • The generation of a Data Management Plan (DMP) is a document that outlines the life cycle of study data, describing how data is generated, collected, documented, shared and preserved
  • The choice and implementation of a study database.
  • To ensure the database provides for data traceability (audit trail) , safety (e.g. infrastructure, access rights) and confidentiality
  • The ongoing quality evaluation of study data, based on error surveillance and correction proposals (e.g. automatic data checks and remote monitoring)
  • The export and provision of study datasets ready for statistical analyses

What do I need to do?

When planning your study:

  • Define your DM strategy to be elaborate in your DMP
  • Define how to ensure the ongoing quality of yours study data (quality checks)
  • Include DM tasks in study work load and planning
  • Include DM aspects in your budget

Based on the study protocol you need to decide on:

  • A list of variables needed for the evaluation of your study
  • The DMP that describes the set-up and management of your data during study implementation
  • The study CRF that can either be in paper or in an electronic form
  • Quality control procedures of any collected data

In many instances it might be an advisable to outsource DM services.

Where can I get help?

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

References

ICH GCP E6(R2) – see in particular guideline

  • 5.5 Trial management, data handling, and record-keeping
Abbreviations
  • CRF – Clinical Report Form
  • CTU – Clinical Trials Unit
  • DM – Data Management
  • DMP – Data Management Plan
  • IMP – Investigational Medicinal Product
  • MD – Medical Device
Basic ↦ Data Handling ↦ Data Management ↦ Purpose
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): Basic ↦ Data Handling ↦ Data Management ↦ Purpose

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