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


Communication can include regular updates between SP-INVSite-INV and study staff during team meetings, newsletter from SP-INV, ongoing study 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 management prior to study conduct


Implemented risk control-measures


Riskdocumentation and communication

  • The Site-INV documents any SAE non-compliance in a study deviation log
  • Applicable study staff is trained on applicable SOPs and/or WIs regarding SAE reporting procedures


QC 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 responsibilities are delegated by the Site.-INV to one key staff member (e.g. documented on the site delegation-log)
  • Staff is trained on adapted safety reporting measures


What do I need to do?

As a SP-INV and based on the risk prevention strategy of your study:

  • Maintain oversight regarding any delegated tasks and/or functions in order to ensure compliance with the risk-based QMS of the study
  • Collect feedback from study staff in order to ensure ongoing effectiveness of risk control-measures
  • Train study staff and communicate potential adaptations to risk control-measures
  • Document all risk related activities, including any evaluation or rational for implemented/ adapted risk control-measures in the Risk Assessment Form (RAF) of your study



Risk communication should be a 2-way street


  • As a SP-INV implement 2-way communication channels with:
    • Site-INV(s) of participant study site(s)
    • Subcontractors (e.g. partners, service providers such as CTU or CRO)
  • 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 control procedures
  • Discuss and define problem-solving strategies
  • In order to reach all potential stakeholders, 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


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 (access liable to costs) – see in particular section

  • Quality Management Systems


  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • QC – Quality Control
  • QMS – Quality Management System
  • RAF – Risk Assessment Form
  • SAE – Serious Adverse Event
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Development ↦ Quality and Risk ↦ Risk Communication ↦ Strategy

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): Development ↦ Quality and Risk ↦ Risk Communication ↦ Strategy

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