Development↦Quality and Risk↦Risk Communication↦Strategy
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
- Facilitate risk reviews
- Insure continual improvement
- Enable to learn from experience (e.g. lessons learned)
- Promote transparency and support to the risk-based QMS of the study
Communication methods may include regular updates between SP-INV, Site-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
- Risk identification: SAE reporting is not done or not within required timeline (24 hr)
- Risk evaluation: is likely 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
- 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
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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