What is it? Why is it important?

The SP-INV and Site-INV are responsible for the ongoing safety of their study participants. They must ensure that risk control measures remain effective and that new potential risks are promptly identified. This can only be achieved through the execution of selective risk reviews.

Questions to address during study conduct include:

  • Have any new risks been identified that were initially not anticipated?
  • Have old risks become less relevant?
  • Are current risk control measures effective or must they be improved?
  • Are risk control measures still relevant with respect to emerging knowledge and expertise?
  • Is study staff up-to-date and trained on current study risks including implemented control measures?

Risk reviews are interactive processes between those implementing risk control measures, and those deciding which control measures to implement. Only through this communicative feedback loop, can it be guarantee that risk measures remain appropriate and effective.

What do I need to do?

As a SP-INV:

  • Re-evaluate any study risks and preventative measures defined at study start
  • Identify any new potential study risks, including changes to existing risks
  • Ensure that implemented preventative measures remain relevant
  • As required, perform or update the risk-benefit assessment of your study. If applicable, implement required steps
  • Document the risk review and include any adaptations or implemented changes to your risk strategy

As a Site-INV:

  • Ensure staff is trained on study risks, defined control measures, including potential adaptations
  • Stay in ongoing contact with the SP-INV of the study regarding safety management and concerns

For more information refer to Quality and Risk in this Study Guide.

Where can I get help?

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

External Links

Swissmedic – see in particular information sheets

  • BM101_10_002e_MB FAQ on clinical trials with medicinal products
  • BW101_10_003e_AA Instruction for reporting during the course of a study
  • MU680_20_004e_MB Medical devices FAQs patients

References

ICH GCP E6(R2) – see in particular guidelines

  • 5.0 Quality management
  • 5.0.3 Risk evaluation
  • 5.0.6 Risk review

ISO 14155:2020 Medical device (access liable to cost) – see in particular section

ISO 31000:2018 Risk management (access liable to cost) – see in particular section

  • Guidelines
Abbreviations
  • CTU – Clinical Trials Unit
  • FAQ – Frequently Asked Questions
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Safety ↦ Safety Risk Review ↦ Aim
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): Conduct ↦ Safety ↦ Safety Risk Review ↦ Aim

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