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 law), ICH GCP, Ethical (EC), and applicable regulatory requirements (e.g. Swissmedic, international).  By selecting an appropriate Clinical Data Management System to manage study data, DM contributes to the generation of high-quality data needed for the statistical analyses.


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 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, data back-up)
  • To perform and validate the installation of a CDMS, including software updates
  • To write applicable SOPs and WIs for the set-up, implementation, and closure of a study database
  • To define 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 support the Site-INV in the design of a study Case Report Form (eCRF) (e.g. study variables, visit plan, 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


ICH GCP E6(R2) – see in particular guideline

  • 5.5 Trial management, data handling, and record-keeping
  • 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 Handling ↦ Data Management in Studies ↦ Aim

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): Basic ↦ Data Handling ↦ Data Management in Studies ↦ Aim

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