What is it? Why is it important?

The sponsor-investigator (SP-INV) is legally responsible to ensure participant protection and reliability of study results. In order to safeguard these aims a risk based QMS, including QA and QC procedures, must be established based on the study design and implementation.

A risk based approach includes to:

  • Define activities and their inherent risks
  • Evaluate and prioritise risks (e.g. frequency and impact)
  • Define risk control measures (e.g. accept, tolerate, reduce, eliminate risks)
  • Report risk event(s) and measures taken to prevent reoccurrence

More

The SP-INV can delegate QMS responsibilities to:

  • A CRO or CTU, with a contract defining delegated tasks
  • Local staff members, with a delegation log defining delegated tasks

Ultimate study responsibility remains with the SP-INV, who ensures the qualification and training of its partners and staff members.

What do I need to do?

Familiarise yourself with:

  • The role and responsibilities of a study SP-INV (e.g. regulatory and GCP requirements)
  • Training requirements (e.g. GCP certificate)
  • How to set-up a risk based QMS for your study
    • Keep main focus on patient safety and reliability of trial results
    • Include QA and QC procedures
    • Consider regional or local QMS requirements (e.g. multi-centre studies)
  • How to document, communicate and train risk management activities

Where can I get help?

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

References

ICH GCP E6(R2) – see in particular guideline

  • 5.0 Quality management

ISO 31000 – see in particular section

  • Risk management: Principles and guidelines (access liable to costs)

Swiss Law

ClinO – see in particular article

  • Art. 2 Definitions

Documents

Abbreviations
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • QA – Quality Assurance
  • QC – Quality Control
  • QMS – Quality Management System
  • SP-INV – Sponsor-Investigator
Basic ↦ Quality and Risk ↦ Responsibilities ↦ 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): Basic ↦ Quality and Risk ↦ Responsibilities ↦ Sponsor-Investigator

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