Development↦Management↦Quality Mgmt. System↦Implementation
What is it? Why is it important?
The Implementation of a Quality Management System (QMS) represents a set of activities and processes, including protective and quality measures in order to ensure:
- Feasibility of study protocol and its design
- Protection of study participants (e.g. safety, privacy, rights)
- Reliability of study results including tools and procedures for data collection and processing
- Documentation of information essential for decision making (e.g. safety, study stop)
The implemented QMS of the study should be risk-based.
Undertaking a risk assessment of the study will gain knowledge and a deeper understanding of potential risks, and how these can be best mitigated.
- Is a risk within acceptable levels or must it be reduced or even eliminated?
- What would be preventive or alternative solutions?
What do I need to do?
Get an overview of the current QMS status at your site(s) and check whether:
- Staff qualifications, CVs and certificates are up-to-date (e.g. GCP training)
- Study relevant SOPs are available, up-to-date and staff trained
- Site infrastructures are able to accommodate study requirements (e.g. IMP/MD handling, work space, storage of biological samples)
Implement and maintain a risk based QMS throughout all study phases, and ensure Site-INV(s) comply with the study QMS.
Ensure risk control measures are proportionate to potential study risks.
For more information refer to Quality and Risk in this Study Guide.
Questions to ask can be:
- What are potential study risks?
- How high is the probability of risk occurrence?
- What is the probability that a risk can be detected?
- How should potential risks be prioritised?
- What are the consequences if something goes wrong?
- What would be applicable mitigating strategies/factors?
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
- 5.1 Quality assurance and quality control
ISO 9001:2015 - Quality Management Systems (access liable to costs) – Requirements
ISO 14155:2020 Medical devices (access liable to costs) - see in particular section
- 9.1 Clinical quality management