What is it? Why is it important?

The risk strategy of a study provides guidance on how to manage study risks. Persons involved in risk management activities or affected by risk control measures should:

  • Receive ongoing information to its effectiveness including potential adaptations
  • Provide ongoing relevant feedback to the risk management team and/or SP-INV

This will

  • Facilitate risk reviews
  • Insure continual improvement
  • Enable to learn from experience
  • Give transparency and support to the QMS of the study

More

Communication can include regular updates between Site-INV and study staff during team meetings, newsletter from SP-INV, regular trainings.

Example of an established risk management process: Safety reporting at a study site

Required process: All SAEs must be reported to SP-INV within 24 hours.

Risk identificationevaluation and prioritisation prior to study conduct

  • Risk identification: SAE reporting is not done or not within required timeline (24 hr.)
  • Risk evaluation: is likeley to occur and will have serious impact on participant safety
  • Risk prioritisation: High priority due to safety risks for study participants

Implemented risk control measures

  • Required SAE reporting procedures are described in a WI
  • Two monitoring visits will be conducted during study conduct in order to assess SAE reporting procedures  

Risk communication

  • Applicable study staff is trained on the WI regarding SAE reporting procedures

CQ and monitoring visit during study conduct

  • Monitoring findings: reporting timeline to SP-INV was delayed in 2 instances
  • Root cause analysis: reporting responsibilities were unclear

Implemented risk control measures and risk communication

 

  • Reporting responsibility was delegated to one main staff member
  • Staff is informed regarding adapted safety reporting measures and receives additional training

     

What do I need to do?

Based on the risk prevention strategy of the study:

  • Maintain oversight regarding any delegated tasks and/or functions in order to ensure QMS compliance
  • Collect feedback from staff in order to ensure ongoing effectiveness of risk control measures
  • Train staff and communicate potential adaptations to risk improvement measures
  • Document all risk related activities, including any evaluation or rational for implemented/ adapted riskcontrol  measures (e.g. the risk assessment tool)

More

Risk communication should be a 2-way street:

  • As a SP-INV implement 2-way communication channels between SP-INV and site(s), SP-INV and subcontractors
  • As a Site-INV provide ongoing relevant feedback to the SP-INV and site staff
  • Schedule team meetings to ensure information flow
  • Clearly define responsibilities within implemented risk procedures
  • Discuss and define problem-solving strategies
  • In order to reach all potential stakeholder applicable information can be documented in a newsletter

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 guidelines

  • 5.0 for Quality management
  • 5.0.5 Risk communication
  • 5.2.2 Addendum: Sponsor oversight

ISO 9001:2015 – see in particular section

  • Quality Management Systems (access liable to costs)

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • QC – Quality Control
  • QMS – Quality Management System
  • SAE – Serious Adverse Event
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Development ↦ Quality and Risk ↦ Risk Communication ↦ Strategy
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 ↦ Quality and Risk ↦ Risk Communication ↦ Strategy

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