Risk Identification - Risk Management Definitions - Quality and Risk - Basic

Risk identification addresses the question: What can go wrong in my study?

Identifying study-risks allows the SP-INV to plan for applicable control measures needed for effective risk management.

Risk identification is made at:

System level: e.g. infrastructure, procedures, electronic equipment, service providers or partners, work space
Staff: e.g. availability/capacity, delegated responsibilities, conflict of interest, qualification, including level of experience and training
Study level: e.g. trial design, study management, data collection, participants, IMP/IMD
Scientific level: e.g. competitors, relevancy

Examples of what can go wrong:

Staff: untrained/insufficiently trained personnel, lack of staff back-up, inadequate time at disposal for study implementation
Safety: no directives for the assessment and reporting of IMP/IMD adverse events, SAE, or SUSAR
Data protection: participant data is accessible to staff not involved in the study
Participant right: not properly informed regarding study withdrawal
Data quality: data is incomplete, not fit for final analysis
Analysis: statistics not applicable for data evaluation
Design: feasibility is questionable resulting in poor participant and staff compliance, study question is not relevant
Documentation: insufficient and incomplete documentation of study related activities
Biological material: lack of quality processes for sample retrieval, handling and storage

As a SP-INV or Site-INV train yourself:

Based on daily practice identify current risks, such as
- Error in drug dosing
- Loss of biological samples
- Time needed for administrative work
- Staff qualifications and fluctuations

Apply the same reasoning to clinical research activities:
- Patient rights, safety and well-being
- Integrity and quality of study results
- Handling of IMP/IMD

Consider critical circumstances and processes with inherent risks:

Study design: such as randomised-, blinded- or cross-over design, required wash-out period
Study participants: vulnerable participants such as pregnant women or children, expected study compliance, drop-outs, lost to follow up
Type of intervention: such as invasive or non-invasive procedures, carried out to improve, maintain or assess participant health
Study inclusion and exclusion criteria: such as participant recruitment problems based on challenging criteria
Methodological aspects: such as identification of treatment(s) and outcome used, statistical power used to test study hypothesis
IC process: such as emergency situations, high recruitment numbers, non-native speakers
Multi-centre studies: such as coordination and proficiency of participating sites
Study partners: such as proficiency and ability to deliver requested services
Informatics: such as access, data privacy protection, access to validated systems, data back-up
Study staff: such as available resources, know-how, training, available time to dedicate to the study

Your local CTU↧ can support you with experienced staff regarding this topic

ICH GCP E6(R2) – see in particular guidelines

ISO 31000 (access liable to costs) – see in particular section

Abbreviations

Basic ↦ Quality and Risk ↦ Risk Management Definitions ↦ Risk Identification

Your Easy Guide to Clinical Studies