Development↦Quality and Risk↦Quality and Risk Management↦Risk Strategy during Study Conduct
What is it? Why is it important?
The implementation of a risk strategy provides structure and guidance on how to manage risks during study conduct. Its aim is to:
- Ensure that the rights and safety of study participants are protected
- Data quality is guaranteed
- Compliance with the study protocol and regulatory requirements (e.g. Swiss laws) is ensured
The implementation of a risk strategy includes to:
- Define and delegate risk responsibilities among study staff
- Facilitate risk reviews during study conduct
- Ensure study risks are under constant surveillance, with a strong focus on the ongoing effectiveness of risk control-measures
- Ensure new potential risks to the study`s Critical-to-Quality factors are not missed
- Guarantee ongoing risk documentation. This is important for risk tracking and proof of risk management
- Collect risk experience that may be useful for the establishment of future risk strategies (e.g. lessons learned)
The study`s risk strategy is summarized in a SOP, to which study staff is trained and required to comply with.
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EXAMPLE
Study: A clinical study assesses the effectiveness of Investigational Medicinal Product (IMP)
Regulatory (Swiss law) requirements state: All Serious Adverse Events (SAEs) must be reported to the SP-INV within 24 hours (i.e. except events that are exempt according to the study protocol).
Identified potential risk: SAEs are not reported within required timeline (24 hr), which results in non-compliance with regulatory requirements.
Risk Assessment
- Based on a risk-based approach (e.g. evaluate and prioritize risk). The risk is defined as “high impact” as participant safety may be jeopardized, and regulatory requirements are violated
- Applicable risk control-measures are defined
RISK STRATEGY
SAE reporting procedures are described in an in a respective Standard Operating Procedure (SOP). Aspects to include are:
Definition of risk-responsibilities and risk-communication lines
- Based on the required SAE-reporting process, define responsibility tasks, to be delegated to appropriate study staff involved in SAE-reporting (e.g. risk-responsibility delegation-log)
- Cleary define SAE-reporting communication lines and required timelines (e.g. who reports SAE occurence to whom within what timeline)
Risk training
Ensure staff with delegated SAE-reporting tasks remain trained, including potential changes to SAE-reporting procedures
Risk Review during Study Conduct
- Plan SAE-reporting review sessions (e.g. monitoring and assessment of implemented SAE-reporting procedures regarding applicability and effectiveness)
Risk documentation
- Based on the established risk assessment form during study planning, complete the documentation with the handling of SAE-reporting during study conduct, including adaptations and implemented improvement measures
- Ensure documentation regarding the handling of SAE-reporting procedures remains up-to date and inspection ready
What do I need to do?
As a SP-INV, define the risk strategy of your study, which includes:
- Risk-responsibilities: risk-tasks are delegated to trained study staff (e.g. risk-responsibility delegation-log)
- Risk-communication lines: defines who must report to whom within what timeline
- Risk training: risk-responsible study staff remains trained on current and changing risk control-measures
- Planned risk reviews during study conduct: the active collection of feedback from study staff to ensure ongoing applicability and effectiveness of risk control-measures, including the occurrence of new risks (e.g. regular risk monitoring, updates between Site-INV and study staff during team meetings)
- Risk documentation during study conduct: ongoing update of the study`s risk-assessment-form to ensure:
- The tracking of decisions, adaptations, and changes of the study`s risk management
- Inspection readiness with proof of risk management and risk control (i.e. in the event of an audit or Swissmedic inspection)
In multicentre studies, the risk strategy may have to be adapted according to local settings.
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Risk communication should be a two-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) SP-INV
- Subcontractors (e.g. partners such as a laboratory, CTU or CRO)
As a Site-INV:
- Provide ongoing relevant feedback to the SP-INV and site staff
- Ensure information flows through regular staff meetings
- Clearly communicate responsibilities regarding implemented risk control-measures
- 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(R3) – see in particular guidelines
- 3.10 for Quality management
- 3.10.1.4 Risk communication
ICH E8(R1) – see in particular guideline
- Art. 3.2 Critical to Quality Factors
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