Your Easy Guide to Clinical Studies

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

• Safety (e.g. risk-benefit ratio, safety reporting) and rights of study participants
• The quality 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 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 exports (e.g. interim- or final 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

As a SP-INV:

• Select a CDMS applicable to your study and able to fulfil regulatory requirements (e.g. Swiss law)
• 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 study protocol and 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

External Links

Swissethics – see in particular

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

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