What is it? Why is it important?

The SP-INV carries the main responsibility for the study and ensures the ongoing:

  • Safety and rights of study participants
  • The quality and integrity of study data


  • Defines what study variables are needed to answer the study question(s)
  • Selects a CDMS able to fulfil regulatory requirements
  • Ensures the proper set-up of the study database, including the validation of the CRF (be it electronic or in paper form)
  • Ensures data collection and processing follow regulatory requirements
  • Regulates data access during and after study completion
  • Defines database locks (interim and final) and export aimed for statistical analysis
  • Defines the DMP that outlines how data will be collected, documented, stored, shared and preserved


The SP-INV can decide to delegate tasks to relevant and qualified staff and experts (e.g. partners). Still, the main and final responsibility remains with the SP-INV

What do I need to do?

As a SP-INV:

  • Select a CDMS applicable to your study and able to fulfil regulatory requirements
  • Select or hire qualified staff that can support you during the planning and set-up of the CDMS (e.g. data manager)
  • Evaluate whether to outsource data management tasks to professional service providers (e.g. CTU)
  • Remember to include data management tasks and equipment in your study budget (e.g. qualified staff such as data manager, statistician, CDMS installation, validation and yearly licencing costs, server and infrastructure maintenance, study database (eCRF) setup costs, amendments during study conduct)
  • Define and describe the management of your study data in the DMP


Regarding publication rights the SP-INV might negotiate upfront with stakeholders:

  • Their involvement (e.g. collection of special data) and thus their rank into publication
  • Publication of partial/site data from participating study sites

Where can I get help?

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

External Links

Swissethics – see in particular

  • Topics/Other Topics/Professional qualifications of the investigator and project leaders of research projects


ICH GCP E6(R2) – see in particular guidelines

  • 1.53 Sponsor definition
  • 5.0 Sponsor responsibilities
  • 5.5 Trial management, data handling, and record-keeping

ISO 14155 Medical Devices - see in particular section

  • 8 Sponsor responsibilities (access liable to costs)

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
  • ClinO – Clinical Trials Ordinance
  • CDMS – Clinical Data Management System
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • DMP – Data Management Plan
  • DM – Data Management
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Handling ↦ Stakeholders ↦ Sponsor-Investigator

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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

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 ↦ Sponsor-Investigator

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