Toolkit for ICH E6 (R2) Quality Risk Management for Small to Medium Size Companies.

Area of Science:

• Clinical Research
• Regulatory Compliance
• Quality Management Systems

Background:

• The ICH E6 Good Clinical Practice (GCP) Guideline was significantly revised in 2016, introducing new requirements for systematic risk management and sponsor oversight in clinical studies.
• Existing risk management solutions are often too complex and costly for small to medium-sized organizations.
• Compliance with updated GCP guidelines presents challenges for smaller research entities.

Purpose of the Study:

• To present a simple, robust, and customizable toolkit for clinical study risk management.
• To facilitate compliance with ICH E6 GCP Guideline revisions for small to medium-sized organizations.
• To address the complexity and adaptability issues of current risk management solutions.

Main Methods:

• Development of a toolkit comprising customizable templates.
• Templates include: Clinical Risk Management SOP, Clinical Risk Management Plan, Vendor Oversight SOP, Vendor Oversight Plan, and Clinical Risk Log.
• Tools were created by members of the DIA GCP-QA Community.

Main Results:

• A practical toolkit designed for ease of use by small to medium-sized organizations.
• The toolkit supports systematic risk management throughout clinical studies.
• Templates facilitate vendor oversight and risk logging.

Conclusions:

• The presented toolkit offers a practical solution for small to medium-sized organizations to implement effective clinical study risk management.
• Adoption of this toolkit can enhance compliance with updated GCP requirements.
• The toolkit simplifies the implementation of quality management in clinical research for smaller entities.