Risk assessment form for clinical research projects

The SCTO risk assessment form is part of a suite of tools and guidelines developed by the Swiss Clinical Trial Organisation to promote high‑quality, risk‑adapted clinical research. The form provides a structured template for documenting trial‑specific risk assessments across key domains such as intervention characteristics, population vulnerability, trial complexity, site experience, and data‑management processes. The SCTO Risk Assessment Form is a practical, user-friendly downloadable tool (licensed under CC BY-NC 4.0) that operationalises the risk assessment requirements of ICH GCP E6(R2) for academic and investigator-initiated studies.

Scope and Content:

• Part A covers system-level risks — risks related to the site or institution — and can be reused across multiple research projects running at the same site, provided it is re-evaluated for each project.
• The trial-level component addresses risks specific to an individual clinical research project.
• Structured, step-by-step instructions with numerous practical examples to help users identify quality risks, evaluate their likelihood and impact, and develop mitigation strategies.
• Complementary user instructions provided as a separate document.

Useful for investigator-initiated clinical studies to:

• Meet GCP E6(R2) requirements for sponsor-level risk assessment in a structured and documented way.
• Set up or improve a risk-based quality management system for a specific trial.
• Prepare for audits or inspections by having a completed, documented risk assessment on file.

Developed by: SCTO Auditing Platform (Switzerland).