What is it? Why is it important?

In studies, the aim of Data Management (DM) is to support researchers in the collection and management of their study data.

 

DM ensures that study data is handled in compliance with the law (e.g. Swiss law, Data Protection Act), ICH GCP, Ethical (EC), and applicable regulatory requirements (e.g. Swissmedic, international). 

 

By selecting an appropriate Clinical Data Management System (CDMS) to manage study data, DM contributes to the generation of high-quality data needed for the statistical analyses, publications and data sharing.

 

High quality data provide confidence in study results, which are an important basis for further research and the ongoing advancement in science (e.g. development of medicinal products, treatment procedures algorithms). 

 

In many ways, DM sets the framework to ensure these aims are met. In this context, the implementation of defined quality procedures are especially important (e.g. quality assurance, quality control).

What do I need to do?

As a SP-INV familiarize yourself with DM tasks involved in the planning and set-up of a study database.

 

Typical tasks include:

  • To add a section in the study budget for DM tasks
  • To select a Clinical Data management System (e.g. CDMS) that complies with the law (e.g. Swiss law) and ICH GCP (e.g. infrastructure, database validation, audit-trail, access protected)
  • To perform and validate the installation of a CDMS, or use a CDMS already installed and maintained by your institution
  • To perform and validate software updates as they become available
  • To write applicable SOPs and WIs for the set-up, data collection, export, and closure of a study database
  • To define (as applicable) a Data Management Plan (DMP) for the study (e.g. outlines the life cycle of study data and describes how data is generated, collected, documented, shared and preserved)
  • To collaborate with the Site-INV on the configuration of a study electronic Case Report Form (eCRF) (e.g. study variables, visit plan, data quality checks, functions to enable/disable randomisation)
  • To close and archive the study database at study completion
  • To export data for statistical analysis

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
  • CDMS – Clinical Data Management System
  • CRF – Clinical Report Form
  • CTU – Clinical Trials Unit
  • DM – Data Management
  • DMP – Data Management Plan
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • MP – Medicinal Product
  • MD – Medical Device
Basic ↦ Data Management ↦ Data Management in Studies ↦ Aim
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

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
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Basic ↦ Data Management ↦ Data Management in Studies ↦ Aim

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