Development↦Quality and Risk↦Study Risk Management↦Risk Identification
What is it? Why is it important?
In order ensure the safety of study participants and the quality of study data, the SP-INV identifies risks related to study processes and data handling.
Risk identification is based on:
- System level: informatics, SOPs, infrastructure, laboratory, available work space, resources such as time and personnel, etc.
- Study level: study design, target population, data collection, Informed Cconsent process, type and complexity of the intervention (e.g. randomisation, double blind)
Based on risk identification the SP-INV implements a risk-based QMS. The scope of the risk-based QMS is based on the evaluation of the study`s risk management, which includes to:
- Evaluate risks on their likelihood of occurrence, ability to be detected, and potential risk impact
- Prioritise risks, and define risk control-measures in proportion to their estimated risk significance (e.g. potential impact on primary- or secondary endpoints)
When writing the study protocol, an estimation of potential study risks and their risk control-measures are defined. During study conduct the management and adaptation of study risks might become necessary. Consequently, risk identification and managment (evaluation & prioritisation, definition of risk control-measures) is a continuous process, starting at the time of protocol writing and only ends upon study completion.
Newly identified risks during study set-up, development and conduct might potentially necessitate a protocol amendment.
What do I need to do?
As a SP-INV you are responsible for the risk identification and management of your study such as to:
- Identify your study risks and ask yourself:
- What can go wrong in my study?
- What could affect patient rights, safety, and well-being?
- What could jeopardise data quality and consequently the integrity and credibility of my study results?
- Document all identified risks and their management in the RAF
- Implement a risk-based QMS with the aim to support the risk identification and management of your study. Include quality assurance and quality control aspects
As a SP-INV or Site-INV:
- Communicate and train staff on the risk management of the study
- Review risk control measures in order to test its ongoing efficacy
- Document ongoing and newly diagnosed risk occurrences, their implemented risk control-measures, including potential deviations and improvement procedures
Use ‘lessons learned’ from previous studies. Previous risk experience can facilitate the risk identification of a planned study.
Examples of study risks or what can go wrong:
- Safety: non-compliant processes in the assessment and documentation of adverse events SAE, SUSAR
- Data protection: participant data becomes accessible to non-study staff
- Participant right: are not properly informed regarding study withdrawal or signing of ICF
- Data quality: data incomplete, unusable for final analysis
- Analysis: statistical method(s) is not applicable for data analysis
- Design: study feasibility is questionable resulting in poor compliance and incomplete dataset
- Biological material: lack of standardised processes for sample retrieval, handling and storage
- IMP/IMD: lack of optimal storage conditions and regulated access control
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 5.0 Quality management
- 5.0.2 Risk identification
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)