What is it? Why is it important?

During study conduct, both SP-INV and Site-INV are responsible to maintain study oversight with the aim to ensure that:


A SP-INV and Site-INV can delegate study tasks, however overall responsibility remains with them.


The study budget represents the total sum of money needed to guarantee for the successful set-up, conduct and completion of a study.


Circumstances that might jeopardize and increase study costs during study conduct are unforeseen events such as:

  • Protocol amendments
  • Inclusion of additional study sites due to poor recruitment at existing study sites
  • Slow recruitment rate with an extended period needed for study conduct, coupled with grant providers with a restricted funding period (e.g. only for 2 years)
  • Staff fluctuations and additional staff requirements resulting in addtional costs and trainings

What do I need to do?

At Site-INV level, oversight tasks during study conduct include to:


At SP-INV level, oversight tasks during study conduct include to:


As a SP-INV and Site-INV, ensure ongoing study oversight by planning and documenting regular staff meetings.


During staff meetings, pending issues and problems are addressed, which ensure the protection of study participants and the quality of study data. In addition, measures are implemented early on avoiding unnecessary delays during study conduct.


Document meetings and decisions taken in an applicable meeting protocol. The meeting protocol provides:

  • Resolution of pending issues
  • Transparency and reference tool for absentees
  • Evidence of study oversight in the event of an inspection by RA (e.g. Swissmedic)

Where can I get help?

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


ICH GCP E6(R2) – see in particular guidelines

  • 4.2.5 Supervision of delegated tasks
  • 4.2.6 Qualification of delegated tasks
  • 4.5 Protocol compliance
  • 4.11 Safety reporting


ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections

  • 10 Responsibilities of the principle investigator

Swiss Law

ClinO – see in particular article

  • Art. 5 Rules of good clinical practice
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • FOPH – Federal Office of Public Health
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • GCP – Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • QMS  -  Quality Management System
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instruction
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Sponsor and Site-Investigator

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): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Sponsor and Site-Investigator

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