What is it? Why is it important?

Study oversight states that both SP-INV and a Site-INV are responsible to maintain ongoing study supervision during study set-up, conduct, and completion.

Study oversight includes but is not limited to:

  • Study progression with respect to expected milestones, mainly linked to participant recruitment during study conduct
  • Ongoing qualification and training of current study staff, especially with respect to delegated responsibilities
  • Adherence to study QMS and its risk control measures
  • Ongoing budgetary control
  • IMP/MD handling

More

Administrative and study relevant tasks can be delegated to applicable study staff, such as a project manager. Nevertheless, final responsibility remains at all times with the respective SP-INV or Site-INV(s).

What do I need to do?

Define study milestones including required timeline needed for milestones to be carried out.

Milestones could be:

  • Study submission to EC/RA
  • Study initiation and training
  • Attainment of expected participant recruitment numbers
  • Last patient last visit
  • Study closure and data analysis
  • Publication(s)Protocol

In order to maintain ongoing study oversight, schedule regular team meetings with study staff and other relevant parties. Document meetings and keep track of open issues.

More

It is essential to schedule regular meetings with the study team as it provides opportunity to discuss:

  • Study participant recruitment problems
  • Risk review and potential adaptation of control measures
  • Organisational issues such as a shortage in resources (e.g. staff, infrastructure, budget)
  • Recurrent issues or problems that might trigger a protocol amendment

Meetings can also be used as a platform where staff can be trained on QMS aspects or newly delegated responsibilities.

With respect to budgetary means, a study might receive financial support only during a specific time period (e.g. financial support is only covered during a 2-year period).

Keeping track of timeline, study activities, and milestones will ensure that the study moves forward as initially planned, and does not extend over the budgeted period.

Multicentre studies:

To organize Site-INV meeting(s) can be highly time and task efficient, as it:

  • Improves site coordination
  • Ensures all investigators have received the same information
  • Allows for questions & answers affecting all sites

Where can I get help?

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

External Links

Swissethics – in particular see

  • Template: Staff List

References

ICH GCP E6(R2) – see in particular guidelines

  • 4 Site-INV responsibilities
  • 5 SP-INV responsibilities

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

  • 9 Responsibilities of the sponsor (SP-INV)
  • 10 Responsibilities of the sponsor investigator (Site-INV)
Abbreviations
  • CTU – Clinical Trials Unit
  • EC/RA - Ethics Committee / Regulatory Authorities
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ Oversight
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): Development ↦ Management ↦ Study Management ↦ Oversight

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