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

The SP-INV:

  • 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 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 ilocks (interim and final) and export aimed for statistical analysis
  • Defines the DMP that outlines how data will be collected, documented, stored, shared and preserved

More

The SP-INV can decide to delegate tasks to relevant staff and experts. Even though main and final responsibility remains with the SP-INV

What do I need to do?

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

More

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

Where can I get help?

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

External Links

Swissethics see in particular

  • Information on professional qualifications – Professional qualifications of the investigator and projet leader

References

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
Abbreviations
  • CDMS – Clinical Data Management System
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • DMP – Data Management Plan
  • DM – Data Management
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Handling ↦ Stakeholders ↦ Sponsor-Investigator
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 ↦ Sponsor-Investigator

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