Monitoring Platform
Monitoring Conduct for Clinical Trial Excellence
The SCTO Monitoring Platform promotes harmonised coordination, data-driven tools, and regulatory alignment by developing monitoring templates, central data monitoring tools, and updated guidelines. These resources support efficient, risk-based oversight in line with Swiss law and ICH E6 and ISO 14155.
The Monitoring Platform has set several main objectives for 2025–2028. Ambitious projects were defined to set these in action.
We invite you to contact us at monitoring@scto.ch if you would like to learn more.
Improving monitoring coordination at a national level
Through the development of monitoring specific tailored documents, the monitoring Platform aims at supporting the coordination of monitoring activities across several CRCs involved in multicentre national studies.
Coordinated Monitoring of Swiss Multicentre Studies
In the SCTO CRC Network, monitoring is carried out locally, using each CRC’s knowledge of language, infrastructure, teams, and eHR systems. This makes monitoring faster, cost-efficient, and sustainable. Uniform standards ensure consistent data quality, delivering reliable results and speeding the translation of research into medical knowledge.
Expected outcomes:
- Working instruction
- Delegation of related tasks
- Defined communication flow between CRCs, study teams, and sponsors
Integrating Innovative Tools into Daily Practice
We integrate central data monitoring (CDM) into routine workflows, enabling efficient, data-driven oversight for multicentre studies. Using SCTO’s standardised CDM templates, teams can monitor data consistently, detect risks early, protect participants, and ensure high-quality results in line with ICH E6 and ISO 14155.
Expected outcomes:
- CDM plan template detailing checks and timing
- Structured CDM report template
Provision of up-to-date information and tools
We aim to keep our tools up to date with ongoing regulatory changes.
Guideline on RBM, Monitoring Plan template, Monitoring Visit Report templates
Regularly updated templates are essential for high-quality and compliant monitoring. Our RBM guideline, monitoring plan, and visit report templates help monitors work consistently and in line with evolving regulations. By continuously improved templates, we facilitate to meet standards, maintain data integrity, and ensure the quality of clinical trials.
Expected outcomes:
- Guidelines on RBM separated from GGOP, adapted to revised Swiss laws, ICH E6 and ISO 14155
- Monitoring Plan template adapted to revised Swiss laws, ICH E6 and ISO 14155
- Monitoring Visits Reports templates adapted to revised Swiss laws, ICH E6 and ISO 14155
Supporting Collaborative Projects with other Platforms
Evaluation and development of products regarding sponsor oversight responsibilities
The Sponsor Oversight Responsibilities (SOR) project, increasingly important under ICH E6 (R3), guides users to relevant tools and documents across Easy-GCS and SCTO platforms, improving understanding and compliance.
Although this project is led from the Project Management Platform, the Monitoring Platform will also contribute to its successful implementation.
Support creation of courses and research trainings for study coordinators
We will support the Education Platform with our expertise in building a research training programme for study coordinators. The focus will be on practical aspects relevant to their daily work, with the goal of strengthening knowledge, enhancing efficiency, and supporting high-quality performance.
In the long term, this initiative seeks to improve the overall quality of clinical research while reducing errors and monitoring findings.
Here is an overview of the important work that the Monitoring Platform has done during the last years.
All tools are also searchable in the SCTO Tools & Resources Navigator at the top of this page.
Monitoring: Risk-Based Monitoring (RBM)
Guidelines for Risk-Based Monitoring
These guidelines outline risk-based monitoring for clinical trials and help identify the appropriate monitoring risk category for each study.
🔗 Risk-Based Monitoring Guidelines
Risk-Based Monitoring Score Calculator
This interactive tool helps research teams assess monitoring needs, generate RBM scores, and ensure efficient, high-quality trial oversight.
🔗 Risk-Based Monitoring Score Calculator
Monitoring: Templates for monitors
Monitoring Plan Template
This template helps design monitoring plans aligned with Swiss and international standards, supporting risk-based strategies for clinical research.
🔗Monitoring Plan Template
Site Initiation Visit Report Template
This template includes a step-by-step checklist for monitors and covers all the important aspects of a site initiation visit.
🔗Site Initiation Visit Report Template
RMV Routine Monitoring Report Template
This template includes a step-by-step checklist for monitors covering all the important aspects of a routine monitoring visit.
🔗RMV Routine Monitoring Report Template
Close-Out Visit (COV) Report Template
This template includes a step-by-step checklist for monitors and covers all the important aspects of a monitoring close-out visit.
🔗Close-Out Visit (COV) Report Template
Routine Monitoring Visit and Close-Out Visit (RMV-COV) Report Template
This up-to-date and user-friendly monitoring template can be used to report a combined routine monitoring visit and monitoring close-out visit.
🔗Routine Monitoring Visit and Close-Out Visit (RMV-COV) Report Template
Templates for Site Initiation Visits (SIV) with corresponding instructions for use
🔗SIV Agenda and Instructions for Use
🔗SIV Attendance & Training Log and Instructions for Use
Template for the Monitoring Site Visit Log with corresponding instructions for use
Log details of monitoring visits at the study site. Supports oversight and documentation of site interactions.
🔗Monitoring Site Visit Log and Instructions for Use
Monitoring: Templates for study coordinators
Delegation log Templates with corresponding instructions for use
Tracks delegation of trial-related tasks, duties or functions from the Investigator and Sponsor to authorised staff.
- For Investigator:
🔗Investigator Delegation Log and Instructions for Use (IFU) - For Sponsor:
🔗Sponsor Delegation Log and Instructions for Use (IFU)
Training Log Templates with corresponding instructions for use
To document the training to study documents for the Site and Sponsor teams.
- Site Training Log Template:
🔗Site Training Log and Instructions for Use (IFU) - Sponsor Training Log Template:
🔗Sponsor Team Training Log and Instructions for Use (IFU)
Templates for Screening, Enrolment and Participant Identification Logs with corresponding instructions for use
- Screening & Enrolment & Identification Log Template:
🔗Screening & Enrolment & Identification Log and Instructions for Use (IFU) - Screening & Enrolment Log Template:
🔗Screening & Enrolment Log Template andInstructions for Use (IFU) - Participant Identification Log Template:
🔗Participant Identification Log Template and Instructions for Use (IFU)
Note to File (NtF) & Deviation Templates with corresponding instructions for use
These templates enable documentation tracking of trial inconsistencies and deviations.
- NtF / Deviation Form:
🔗Note to File – Deviation Form and Instructions for Use (IFU) - NtF / Deviation Log:
🔗Note to File – Deviation Log and Instructions for Use (IFU)
IMP/IMD Accountability Log Templates with corresponding instructions for use
- Site level:
🔗Site IMP-IMD Accountability Log and Instructions for Use (IFU) - Participant level:
🔗Site IMP-IMD Accountability Log and Instructions for Use (IFU)
Participant Adverse Event Log Template with corresponding instructions for use
- To be used as a source document, e.g. for studies with healthy volunteers.
🔗Participant AE Log and Instructions for Use (IFU)
Monitoring: Central Data Monitoring (CDM)
Guideline Central Data Monitoring in Clinical Trials
This fact sheet explores central data monitoring (CDM), its role in data quality and oversight, and clarifies terminology and guidance for implementation.
Monitoring: Other Position Papers and Guidelines
Monitoring in Non-Interventional Human Research Projects
This position paper offers recommendations for monitoring strategies in non-interventional studies, from new data collection to reuse of clinical data or samples.
🔗Position paper: Monitoring in Non-Interventional Human Research Projects
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
Jocelyne Chabert – Coordinator, CRC Geneva
Sandra Handgraaf – Contributor, CRC Geneva
Sara Mantero – Member, CRC Lausanne
Laetitia Gallego – Contributor, CRC Lausanne
Markus Vaas – Member, CTC Zürich
Kälin Simone – Member, CTU HOCH St.Gallen
Alexandra Kränzlin – Contributor, CTU HOCH St.Gallen
Yves Franzosi – Member, CTU-EOC Lugano
Paola Messina – Contributor, CTU-EOC Lugano
Sophie Mermoud – Member, DCR Bern
Klaus Ehrlich – Member, DKF Basel
Julia Manzetti – Contributor, DKF Basel
Luzia Steiner – Voluntary Contributor, Swiss Cancer Institute
Christina Huf – Scientific Affairs Manager & Liaison Officer, SCTO
Jocelyne Chabert
Coordinator, CRC Geneva
Sophie Mermoud
Member, DCR Bern
Kälin Simone
Member, CTU HOCH St.Gallen
Markus Vaas
Member, CTC Zürich
Christina Huf
Scientific Affairs Manager & Liaison Officer
Klaus Ehrlich
Member, DKF Basel
Yves Franzosi
Member, CTU-EOC Lugano
Sara Mantero
Member, CRC Lausanne
Other Platform Contributors
Team Members
Jocelyne Chabert – Coordinator, CRC Geneva
Klaus Ehrlich – Member, DKF Basel
Yves Franzosi – Member, CTU-EOC Lugano
Sara Mantero – Member, CRC Lausanne
Sophie Mermoud – Member, DCR Bern
Kälin Simone – Member, CTU HOCH St.Gallen
Markus Vaas – Member, CTC Zürich
Christina Huf – Scientific Affairs Manager & Liaison Officer
Laetitia Gallego – Contributor, CRC Lausanne
Sandra Handgraaf – Contributor, CRC Geneva
Alexandra Kränzlin – Contributor, CTU HOCH St.Gallen
Julia Manzetti – Contributor, DKF Basel
Paola Messina – Contributor, CTU-EOC Lugano
Luzia Steiner – Voluntary Contributor, Swiss Cancer Institute