Auditing Platform

Expert Auditing for Quality-Driven Clinical Research

The SCTO Auditing Platform ensures that Swiss clinical trials and SCTO Clinical Research Centre services consistently meet the highest regulatory and operational standards. Through expert audits, sharing of best practices, and harmonisation of processes across CRCs, we support sponsors and sponsor-investigators in strengthening quality systems and maintaining GCP compliance.

The Auditing Platform has set three main objectives for 2025–2028, supported by several ambitious projects.
We invite you to contact us at auditing@scto.ch if you’d like to learn more or get involved!

Strengthening Auditing Compliance within the SCTO Network

We aim to enhance auditing compliance within the SCTO Network through continued development of auditing and best practice working groups, and by providing auditing services to other SCTO Platforms, CRCs, and researchers.

Projects include:

Auditing Services and Auditor Pool

Expanding and improving auditing services by maintaining a skilled auditor pool, offering targeted audits, and refining communication for greater transparency and collaboration.

Expected outcomes:

Expanded auditing services, including smaller, targeted audits for specific compliance challenges
A sustained and highly trained auditor pool with ongoing training
Streamlined auditing processes, including flexible formats such as consultations and short audits
Increased compliance across a wide range of clinical research areas

Vendor Qualification – Auditing Clinical Data Management Systems (CDMS)

Conducting vendor qualification audits of clinical trial management systems and other third-party services to verify compliance, safeguard data integrity, and reduce risks.

Expected outcomes:

Greater reliability and security of external vendors, particularly in data management
Improved monitoring and control over third-party risks
Sharing of audit findings within the SCTO Network (in agreement with the Data Management Platform)

Communication of Audit Findings and Recommendations

Promoting the ongoing dissemination of audit findings and lessons learned to CRC staff, researchers, and stakeholders, encouraging a culture of continuous compliance.

Expected outcomes:

Structured and continuous sharing of compliance best practices
A proactive, well-informed research community that adapts to regulatory changes
Strengthened collaboration within the SCTO CRCs Network
Publications of findings on the SCTO Tools & Resources website

Review and Improvement of Auditing / QA Tools

Refining risk-assessment forms and internal auditing documents to improve effectiveness and efficiency of QA processes.

Expected outcomes:

Updated risk-assessment forms
More targeted and efficient audits
Optimised use of resources

Fostering Knowledge Exchange within the SCTO Network

We aim to foster knowledge exchange and contribute actively within the SCTO Network.

Projects include:

User Testing of Updated GGOP Version

Testing the revised Guideline for Good Operational Practice (GGOP) with CRC staff, coordinators, and investigators to ensure it is user-friendly and practical.

Expected outcomes:

A clear and user-friendly reference tool to foster compliance
A comprehensive reference for auditors
Ongoing improvement of GGOP based on feedback (published on SCTO Tools & Resources)

Regular Updates of GGOP to Reflect Regulatory Requirements

Ensuring the GGOP reflects the latest ICH GCP and HRA standards to safeguard trial integrity, ethics, and data security.

Expected outcomes:

Regularly updated GGOP reflecting evolving standards
Improved compliance and reduced risk of non-complianc
Strengthened credibility of CTUs as service providers

Expansion of GGOP to New Operational Practices

Extending the GGOP to cover digital health, decentralised trials, and other emerging practices.

Expected outcomes:

An expanded GGOP covering a broader range of practices
Greater compliance with evolving standard
New publications and resources shared on SCTO Tools & Resources

Building Synergies with National and International Research Institutes

We aim to build synergies with national and international infrastructures, particularly ECRIN, through one focused project:

Tailored Documents, Checklists, and Tools for DCC Preparation

Supporting CRCs preparing for ECRIN Data Centre Certification (DCC) with tailored resources, planning tools, and readiness guidance.

Expected outcomes:

Customised guides and checklists for DCC preparation
Enhanced understanding of resources and certification steps
Increased adoption of ECRIN standards
Resources shared via the SCTO Tools & Resources platform or restricted access areas

Here is an overview of the important work that the Auditing Platform has achieved in recent years.
All tools are also searchable in the SCTO Tools & Resources Navigator at the top of this page.

Auditing: QMS Documents for Audit Conduct and Compliance

Guidelines for Good Operational Practice (GGOP)
Provides common standards for professional and operational practice in clinical research, used by the SCTO’s CTU Network, investigators, and sponsors. The guidelines help ensure participant safety, high-quality standards, and efficient use of academic budgets.
🔗Guidelines for Good Operational Practice

Risk Management
A Risk Assessment Form for sponsor-investigators to ensure potential risks of a clinical research project are addressed in line with current GCP requirements.
🔗Risk Assessment Form

User Instructions
Guidance for completing the Risk Assessment Form.
🔗Instructions

Video Introduction
A short video explaining how to manage study risks using the Risk Assessment Form.
🔗Video

Audit and Inspection Findings: Lessons Learned

With GCP audits and inspections becoming increasingly frequent and rigorous, audit-readiness is essential for all involved in clinical research.

The SCTO Auditing Platform collects and shares key findings from audits, inspections, and regulatory authorities, building a growing repository of practical insights.

Each entry provides a clear summary of findings with practical recommendations, helping research teams in their daily work and in preparing for audits, inspections, and CAPAs.

Stay informed. Stay ready. Strengthen your GCP practice.

Focus areas include:

Quality Management System

QMS and regulatory compliance – ensuring systems and processes align with standards

Findings related to the robustness of the Quality Management System (QMS) and compliance with regulatory requirements, including e.g. inadequate risk management, poor deviation handling, or ineffective CAPA processes.
Cases:
● Quality Goals and Objectives → Defining measurable QC methods to guide improvements in line with GGOP requirements.
🔗Quality Goals and Objectives

● Quality Management Review (QMR) → Assessing the adequacy, suitability, and effectiveness of a QMS.
🔗 Quality Management Review (QMR)

● Quality Policy → Defining overarching objectives for QMS functioning and decision-making.
🔗Quality Policy

● Periodic Review and Revision Process → Ensuring document integrity, reliability, and compliance over time.
🔗 Periodic Review and Revision Process

● CAPA Management and Non-Conformities → Defining a formal process for managing issues and preventing recurrence.
🔗 CAPA Management and Non-Conformities

● CAPA Classification and Documentation → Establishing structured control measures for corrective and preventive actions.
🔗 CAPA Classification and Documentation

● Non-Conformances → Providing a framework for capturing and analysing non-conformances
🔗Non-Conformances

Personnel Qualification and Training

Ensuring appropriately educated and qualified staff is involved in clinical research

Findings concerning insufficient, undocumented, or outdated training or qualification of staff (GCP, regulatory requirements, protocol-specific procedures), or the use of relevant systems and tools.

Case:

QMS Responsibilities → Defining responsibilities for implementing and maintaining a risk-based QMS.
🔗QMS Responsibilities

Facilities and equipment management

Ensuring that IMP/MD, biological samples and any other facilities and equipment comply with requirement standards.

Pharmacovigilance and patient safety

Monitoring and safeguarding trial participants safety.

Findings related to delays, omissions, or inconsistencies in adverse event reporting, inadequate causality assessments, or failures in safeguarding participant safety.

Document control

Ensuring accuracy, accessibility, and compliance of records

Case:

Lack of document management process
🔗 Document control

Data Governance & Protection

Maintaining security and integrity of study data

Findings concerning weaknesses in data integrity, such as uncontrolled system access, missing audit trails, insufficient backups, or non-compliance with data protection regulations.

Knowledge Transfer and Auditor Training

The Auditing Platform contributes to knowledge transfer and develops auditor expertise across the SCTO Network. Through audits, training, and collaborative activities, the platform strengthens the skills of auditors and ensures that CRCs can maintain high-quality, compliant research practices.

Key activities include:

CRCs audits, assessments, and consultation visits – providing direct support and feedback to strengthen quality systems -Lausanne (2023)
Pilot and formal audits – including St. Gallen and Zurich (2020), Basel (2021), Geneva (2021), CTU Bern (2022)and EOC Ticino (2024)
Vendor qualification audits – focusing on EDC systems to ensure regulatory compliance and data integrity
Provision of external audits – offering support to sponsors as an additional quality safeguard
Auditor pool and training – developing and maintaining a skilled pool of auditors with continuous training opportunities

(Note: internal audit documents are not for publication.)

Meet the Platform Team

Meet the individuals whose expertise and collaboration drive each Platform forward. Together, they help strengthen clinical research across Switzerland through shared knowledge, leadership, and innovation.

Team Members

Yuliya Plutino – Coordinator, CTC Zürich
Anja Eskat – Contributor, CTC Zürich
Isabelle Mercier – Member, CRC Geneva
Andreja Vuijcic Zagar – Member, CRC Lausanne
Laetitia Gallego – Contributor, CRC Lausanne
Synove Otterbech – Member, CTU HOCH St.Gallen
Geraldine dal Pra – Member, CTU-EOC Lugano
Valerie Progin – Member, DCR Bern
Chiara Raso – Contributor, DCR Bern
Christine Otieno – Member, DKF Basel
Yolanda Martin Mosquera – Contributor, DKF Basel
Britta Tschanz – Voluntary Contributor, Swiss Cancer Institute
Christina Huf – Scientific Affairs Manager & Liason Officer, SCTO