Your Easy Guide to Clinical Studies

A risk-based Quality Management System (QMS) sets its focus on the identification and managment of potential study risks instead of implementing a “one size fits all QMS”.

A risk-based QMS entails that researchers proactively implement a Quality by Design (QbyD) approach, focusing on the study`s Critical to Quality (CtoQ) factors to ensure the:

• Rights and safety of study participants
• Ability to answer the research question by generating reliable, interpretable, and meaningful study results

 

A risk-based QMS may include a risk-based:

• Monitoring plan
• Data management plan
• Statistical Analysis Plan
• Approach to study processes procedures
• Staff trainings including further education
•  IMP / IMD handling procedures
• Material management (e.g. laboratories, sample workflow)

 

The establishment of a risk-based QMS should be fit for purpose, and proportional to the data being collected and the risk to study participants.

More

As a SP-INV:

• Establish a fit for purpose risk-based QMS, that is operationally feasible. Abstain from introducing of unnecessary complexity
• Use a QbyD approach, which includes the identification of CtoQ factors
• Identify risks threatening the integrity of the study`s CtoQ factors and implement applicable risk control-measures
• Maintain a risk-based QMS throughout all study phases, including study archiving
• Apply processes that ensure ongoing review of CtoQ factors and applicable risk control measures during study conduct, analysis and reporting
• In multi-centre studies ensure the site (e.g. Site-INV, site staff) remains trained and comply with QMS requirements

 

As a Site-INV, get an overview of the current QMS status at your site:

• Train study staff on the implemented risk-based QMS
• Check if staff qualifications, CVs and certificates are up-to-date (e.g. GCP)
• Check if study relevant SOPs are current, available, and trained
• Ensure site infrastructures are able to accommodate study requirements (e.g. IMP / IMD handling, work space, storage of biological material)

References

ICH GCP E6(R2) – see in particular ICH GCP principles and guidelines

• Main principle: Quality by design should be implemented to identify factors critical to trial quality
• Principle 6. Quality should be built into the scientific, operational design, and conduct of the trial
• 3.10 Quality management
• 3.11 Quality assurance and control assurance

ICH E8(R1) – General 2.2 Scientific approach in clinical study design

• 3. Designing quality into clinical studies
• 3.1 Quality by design of clinical studies
• 5. Design elements and data sources for clinical studies

ISO 9001:2015 (access liable to costs) – see in particular section

• Quality Management Systems

Documents

• Risk Assessment Form for Clinical Research Projects