What is it? Why is it important?

The risk strategy of a study provides structured 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 approach will

 

Communication methods may include regular updates between SP-INVSite-INV and study staff during team meetings, newsletter from SP-INV, ongoing study trainings.

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Example of an established risk management process: Safety reporting at a study site for clinical trials with Investigational Medicinal Product (IMP)

Required process: All SAEs must be reported to SP-INV within 24 hours (except events that are exempt according to the study protocol).

 

Risk management prior to study conduct

 

Implemented risk control-measures

  • Clearly defined SAE reporting procedures described in a SOP or WI
  • Two monitoring visits will be conducted during study conduct in order to assess compliance with SAE reporting procedures  

 

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

 

Implemented risk control-measures and risk communication

  • SAE 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 in alignment with 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

More

 

Risk communication should be a 2-way process

Effective risk communication requires open and continuous exchange between all stakeholders.

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
  • Ensure information flow through regular team meetings
  • Clearly define responsibilities within implemented risk control procedures
  • Discuss and define problem-solving strategies

 

To reach all potential stakeholders, applicable information and critical updates can be shared via  newsletter or other structured communication methods

Where can I get help?

Your local Research Support Centre can assist you with experienced staff regarding this topic

  • Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch

  • Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch

  • Bern, Department of Clinical Research (DCR), dcr.unibe.ch

  • Geneva, Clinical Research Center (CRC), crc.hug.ch

  • Lausanne, Clinical Research Center (CRC), chuv.ch

  • St. Gallen, Clinical Trials Unit (CTU), h-och.ch

  • Zürich, Clinical Trials Center (CTC), usz.ch

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 (access liable to costs) – see in particular section

  • Quality Management Systems

Swiss Law

ClinO – see in particular article

  • Art. 57a Reporting of serious adverse events

Documents

Abbreviations
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP – Investigational Medicinal Product
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

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.