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Safety Platform

Driving Safety, Supporting Investigators.

The SCTO Safety Platform promotes effective safety management in clinical research by offering expert guidance, training, practical tools, and reporting templates. We empower clinical teams to navigate complex safety requirements, strengthen safety oversight, ensure compliance with Swiss regulations, and prioritise participant safety.

View all Safety Tools

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

 

Harmonisation of Safety Management

We aim to enhance safety compliance across the SCTO Network through development of:

  • SOPs, guidelines, templates, and working instructions
  • Risk-based strategies for safety evaluations

Ongoing Safety Evaluation

Ensures that Sponsor-investigators maintain complete and continuous safety oversight throughout a trial, in full alignment with ICH-GCP and other regulations.

This proactive approach enables earlier detection of safety signals and strengthens participant protection.
Referenced laws: Art. 15 HRA; Art. 37 & 43 ClinO and ICH E6 (R3) GCP.

Data Safety Monitoring Board (DSMB)

Standardises DSMB tools and resources across the network by providing guidance on DSMB needs and composition, a DSMB charter, and report templates.

This harmonisation improves the quality and consistency of trial oversight and supports Sponsor-investigators in meeting regulatory expectations.

Alignment and Development of Current Tools

We continuously review and update existing tools to ensure:

  • Regulatory compliance
  • Improved effectiveness
  • Alignment with current practice

Expected outcome:
Reliable, up-to-date safety tools tailored to Sponsor-investigator needs, including:

  • (e)SAE forms
  • Online safety training
  • Safety Expert Finder
  • Revised Easy-GCS – safety part

Education of the Clinical Research Community and Public

Adverse Event (AE) Coding
Ensures the accuracy and consistency of Adverse Event (AE) coding by providing:

  • Practical tools for AE documentation

  • Educational materials (video tutorials/trainings)

Safety in Category A Clinical Trials
Provides Sponsor- investigator with clear guidance and up-to-date information on safety management in clinical trials of category A, including:

  • SCTO guidelines and video trainings
  • Stakeholder meetings and newsletter
  • Revised Easy-GCS

Further Development of the National PPI Framework

PPI Training
Resources for patients and public to engage in safety management during clinical trials.

Expected outcome:
Guidelines, videos, and tools for training participants in safety procedures.

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

 

Participant safety is of utmost importance and must be considered throughout the conduct of a clinical study.

Need support with safety management?
The Safety Expert Finder provides an overview of the key safety processes and helps you quickly identify the right experts and resources to address your safety questions. We are happy to provide advice free of charge. Any collaboration beyond this may be considered a chargeable service of the Clinical Research Center (CRC) contacted or the Swiss Cancer Institute, and you will be informed in advance.

Bringing safety experts on board can lead to safer clinical research studies.

Contact us for advice or to initiate cooperation: safety@scto.ch

Safety Expert Finder

We can help you with the preparation, review, or study-specific adaptation of the following important safety management documents.

Protocol
We can advise you on how to complete the safety section of your study protocol, for example:

  • which adverse events (AEs) to collect and for which period of time 
  • which grading system for severity and causality to use and how to assess AEs
  • which safety reporting procedures to follow. 

Information and consent form
We can advise you on how to complete the risks and discomfort section of your information and consent form, for example which adverse events (AEs) you should list when informing your participants.

Get in touch with a safety expert
All of the safety experts in our Network can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

(Serious) adverse event forms
We can advise you on how to prepare your study-specific adverse event (AE) and serious adverse event (SAE) forms both for case report forms (CRFs) and source documents. For SAE reporting, we can also provide templates.

Get in touch with a safety expert
All of the safety experts in our network can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Safety management plan (SMP) (for extensive trials)
A safety management plan (SMP) defines all the safety-related activities of a study (e.g. serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) processing, responsible persons, communication lines, documentation requirements, timelines, and unblinding).

We can advise you on how safety reporting and safety management can be organised in your study with respect to allocated responsibilities as well as legal and contractual obligations (e.g. reporting timelines, contacts, allocation of responsibilities, who reports to whom, communication flow, query management, monitoring, oversight of reports, and reporting). We can also help you write a comprehensive safety management plan. 

Get in touch with a safety expert
The safety experts from the CTU HOCH St.Gallen, CTU-EOC Lugano and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Agreements
We can help you set up and/or review any agreement required to define responsibilities and obligations with respect to the procedures for collecting, processing, evaluating, reporting, and exchanging safety information (e.g. a safety data exchange agreement).

Get in touch with a safety expert
The safety experts from the CRC Geneva, CTU-EOC Lugano, CTU HOCH St.Gallen and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Data safety monitoring board (DSMB)
We can help you set up a data safety monitoring board (DSMB), which is an independent group of experts that regularly reviews your study’s safety and, when appropriate, efficacy data. Further, we can provide support on writing a DSMB charter in which duties of the DSMB and timelines are defined.

Get in touch with a safety expert
The safety experts from the DKF Basel, CRC Geneva, and the CTU-EOC Lugano can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Investigator’s brochure (IB)
We can help you prepare the safety-related parts of your investigator’s brochure (IB): Adverse event (AE) listing, a summary of data, and guidance for the investigator part, which includes a reference safety information (RSI) section.

We can write the IB on your behalf.

Get in touch with a safety expert
The safety experts from the CRC Lausanne can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

We can help you from start to finish with the handling of safety events that occur in your study.

Triage
We can advise you on how to ensure that cases requiring expedited reporting are submitted to the ethics committee and regulatory authorities within applicable timelines. You can request services for the registration and assessment of each incoming event.

Get in touch with a safety expert
The safety experts from the DKF Basel, CRC Geneva, CRC Lausanne, CTU-EOC Lugano, CTU HOCH St.Gallen, CTC Zürich, and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Medical assessment
On behalf of the sponsor, we can provide a medical assessment and review each incoming event with regard to causality, severity, seriousness, and expectedness.

Get in touch with a safety expert
The safety experts from the DKF Basel, CRC Geneva, CTU-EOC Lugano, CTC Zürich and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Data entry
We can advise you on how to enter incoming reportable events into a case report form (CRF) and how to record serious adverse events (SAEs) on a specific line listing. 

We can manage data entry on your behalf. We can also maintain all SAEs, other reportable events, and any follow-up communication with any information to or from the sponsor or authorities in the trial master file (TMF).

Get in touch with a safety expert
The safety experts from the DKF Basel, CRC Geneva, CRC Lausanne, CTU HOCH St.Gallen, CTC Zürich, and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Narrative writing
We can advise you on how to write a short description (“narrative“) of all serious adverse events (SAEs), all adverse events (AEs) leading to discontinuation, and AEs of special interest that occur during your trial. These narratives are included in your final clinical study report (CSR).

Get in touch with a safety expert
The safety experts from the DKF Basel, CRC Geneva, CRC Lausanne, CTU-EOC Lugano, CTU HOCH St.Gallen, CTC Zürich, and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Query management
We can advise you on how to ensure the completeness and accuracy of all cases.

We can also manage queries on your behalf. In the event of missing information or discrepancies, we issue queries and send them to the reporter. Once the reply is received, we update or amend data accordingly.

Get in touch with a safety expert
The safety experts from the DKF Basel, CTC Geneva, CRC Lausanne, CTU-EOC Lugano CTU HOCH St.Gallen, CTC Zürich, and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

We can advise you on how to record events in an internationally standardised manner.

 We can register cases and inform authorities, investigators, and others on your behalf about events that occur during a clinical trial using internationally standardised medical terminology (e.g. CTCAE or MedDRA, see below) in order to facilitate information sharing and enable meaningful analysis.

Common Terminology Criteria for Adverse Events (CTCAE)
The Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology resource that can be used for adverse event (AE) reporting. It is published by the US National Cancer Institute (NCI) and describes the severity of organ toxicity for patients receiving cancer therapy, but it can be used for other indications as well (e.g. in the areas of internal medicine and infectious diseases). A grading scale (severity) is provided for each AE term. It incorporates certain elements of MedDRA terminology.

Get in touch with a safety expert
The safety experts from the DKF Basel, CRC Geneva, CRC Lausanne, CTU-EOC Lugano, CTU HOCH St.Gallen, CTC Zürich, and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Medical Dictionary for Regulatory Activities (MedDRA)
The Medical Dictionary for Regulatory Activities (MedDRA) is a standard, international medical terminology resource developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The MedDRA can be used to code different medical concepts such as symptoms, diseases, diagnoses, and therapeutic indications as well as health effects and device malfunction.

Get in touch with a safety expert
The safety experts from the DKF Basel, CRC Geneva, CRC Lausanne, CTU-EOC Lugano, CTC Zürich, and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Electronic case report forms (eCRFs) with integrated adverse event (AE) catalogues
We can provide electronic case report forms (eCRFs) with integrated catalogues for adverse event (AE) assessment so that you can directly select a term.

Get in touch with a safety expert
The safety experts from the DKF Basel, DCR Bern, CRC Geneva, CRC Lausanne, CTU HOCH St.Gallen, CTC Zürich, and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Certain events (SAEs, SADEs, SUSARs, etc.) require prompt reporting to the sponsor/sponsor-investigator and expedited reporting to the authorities (e.g. Swissmedic, the ethics committee, and other authorities as needed) in order to meet the legally required timelines. We can advise you on the correct procedure.

We can also report these events on your behalf using specific forms and channels.  

To sponsor-investigator/sponsor
We have developed a set of comprehensive forms for serious adverse event (SAE) collection and reporting from the investigator to the sponsor-investigator as well as for sponsor-investigator case assessment. You can download the safety reporting forms for free from the SCTO Tool Finder.

Get in touch with a safety expert
All of the safety experts in our Network can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

To ethics committee (via BASEC)
We use the dedicated safety reporting portal (safety form) BASEC (Business Administration System for Ethics Committees) for the notification of any safety reports and immediate safety and protective measures to the concerned ethics committee(s) (EC(s)).

Get in touch with a safety expert
All of the safety experts in our Network can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

To Swissmedic
We report and can report on your behalf the following to Swissmedic:

  1. Suspected unexpected serious adverse reactions (SUSARs) and safety measures occurring in category B and C clinical trials of investigational medicinal products (IMPs) via electronic submission and eDok folder structure
  2. Serious adverse device effects (SADEs) and device deficiencies with SAE potential and safety measures occurring in category C clinical trials of medical devices via Swissmedic’s eMessage portal and clinicaltrials.devices@swissmedic.ch
  3. Serious adverse drug reactions (SADRs), unexpected ADRs, and SUSARs occurring in category A clinical trials of IMPs via the online ElViS (Electronic Vigilance System) portal; for this type of trial, pharmacovigilance rules apply
  4. Serious incidents occurring in category A clinical trials of investigational medical devices (IMDs), and of in vitro device (IVD) performance studies via materiovigilance@swissmedic.ch; for this type of trial, materiovigilance rules apply
  5. Safety events occurring in clinical trials with transplant products (TrP), gene therapy (GT) medicinal products, or products containing genetically modified organisms (GMOs) via biovigilance@swissmedic.ch

Get in touch with a safety expert
All of the safety experts in our Network can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

We can advise you on how to write the required annual safety report, a concise summary of your ongoing study status, including all relevant safety information.

We can write it on your behalf.

Annual Safety and General Progress Trial Report
Annual reporting is mandatory for all trials conducted under ClinO and ClinO-MD regulations, namely all types of interventional studies. 

The report must include both an evaluation of participant safety and a general overview of the clinical trial’s progress; it must be submitted once per year to the Ethics Committee (EC) and, where applicable, to Swissmedic (i.e., for studies classified as risk category B or C).

Swissethics, the Swiss Association of Research Ethics Committees, has developed templates for writing the Annual Safety and General Progress Trial Report for clinical trials according to Swiss regulations.

These templates can be used for Investigator initiated trials (IITs) and can be downloaded from https://swissethics.ch/en/templates/meldungen

We can write it on your behalf.

Get in touch with a safety expert
All of the safety experts in our Network can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Development safety update report (DSUR) for EU trials on investigational medicinal products (IMPs)
A development safety update report (DSUR) is the mandatory format for clinical trials with investigational medicinal products (IMPs) in European Union member states. DSUR is also accepted by Swiss Ethics Committees and Swissmedic but it only covers the safety reporting obligation. It means that if you have a DSUR for your trial, you still need to submit the progress report (see above, Annual Safety and General Progress Trial Report).

We can write it on your behalf. 

Get in touch with a safety expert
The safety experts from the DKF Basel, CRC Geneva, CTU-EOC Lugano, CTU HOCH St.Gallen, and the Swiss Cancer Institute can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

Some local experts have international safety experience and can also report on your behalf to the following:

  • Austrian ethics committees (ECs) and competent authorities (CTU HOCH St.Gallen only)
  • German ethics committees (ECs) and competent authorities (CTU HOCH St.Gallen only)
  • EudraVigilance (Swiss Cancer Institute only)

Get in touch with a safety expert
Contact us for advice or to initiate cooperation (safety@scto.ch).

We can advise you on how to write the safety part of the clinical study report (CSR) for your clinical trial, in which you have to:

  1. describe the overall adverse event experience, including the frequency, rate, and occurrence of all adverse events, as well as each death, all serious adverse events (SAEs), and other significant adverse events
  2. provide tabular categorisation and line listings of SAEs

We can review this information or write it on your behalf.

Get in touch with a safety expert
All of the safety experts in our Network can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

We can advise you on how to prepare the safety part of individual papers.

We can also review the safety part or write it on your behalf.

Get in touch with a safety expert.
All of the safety experts in our Network can support you on this topic. Contact us for advice or to initiate cooperation (safety@scto.ch).

SCTO Safety Platform

Guideline: Safety Reporting for Category A Trials
Guidance for safety reporting procedures specific to Category A clinical trials, link to be published.
Guideline: Safety Reporting for Category A Trials

Guideline for Safety Management
General guideline to support sponsor-investigators in setting up and maintaining safety management systems across diverse clinical research projects.
not yet available.

Electronic SAE Processing: Standardisation Guideline
A forthcoming guideline to support the standardised processing and reporting of electronic Serious Adverse Events (eSAEs) within the SCTO Network.
Not yet available.

Serious Adverse Event Report Form for Investigational Medicinal Products (IMPs)
Template for SAE notifications in Clinical Trials involving an Investigational Medicinal Product (IMP).
Serious Adverse Event Report Form for IMPs

Serious Adverse Event Report Form for Other Clinical Trials
Template for SAE notifications in Other Clinical Trials (ClinO Art. 63).
Serious Adverse Event Report Form for Other Clinical Trials

Serious Adverse Event or Device Deficiency Report Form for Investigational Medical Devices (IMDs)
Template for SAE or Device Deficiency (DD) reporting in Clinical Trials involving an Investigational Medical Device.
Serious Adverse Event or Device Deficiency Report Form for Investigational Medical Devices (IMDs)

Serious Adverse Event or Device Deficiency Report Form for In Vitro Diagnostic Medical Devices (IVDs)
Template for SAE or DD reporting in Clinical Trials involving an In Vitro Diagnostic Medical Device (IVD).
Serious Adverse Event or Device Deficiency Report Form for In Vitro Diagnostic Medical Devices (IVDs)

Serious Events (SE) Form for Research Projects not Involving Clinical Trials (HRO)
Template for SE notifications in Human Research Ordinance (HRO) research projects (HRO Art. 21).
Serious Events (SE) Form for Research Projects not Involving Clinical Trials (HRO)

Online Safety Trainings
Free training to supplement general GCP education.

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.

Elena Porro – Coordinator, CTU-EOC Lugano
Fabiana Tirone – Member, CRC Geneva
Laurène Cagnon – Member, CRC Lausanne
Emilien Breat – Contributor, CRC Lausanne
Clara Landwehr Lardelli – Member, CTC Zürich
Samantha Chan – Member, DCR Bern
Elke Hiendlmeyer – Member, CTU HOCH St.Gallen
Alexandra Kränzlin – Contributor, CTU HOCH St.Gallen
Klaus Ehrlich – Member, DKF Basel
Heidi Baumgartner – Voluntary Contributor, Swiss Cancer Institute
Stephanie Maissen – Scientific Affairs Manager & Liaison Officer, SCTO

Elena Porro

Coordinator, CTU-EOC Lugano

Laurène Cagnon

Member, CRC Lausanne

Klaus Ehrlich

Member, DKF Basel

Elke Hiendlmeyer

Member, CTU HOCH St.Gallen

Clara Landwehr Lardelli

Member, CTC Zürich

Kristina Stojkov

Member, CRC Bern

Fabiana Tirone

Member, CRC Geneva

Stephanie Maissen

Scientific Affairs Manager & Liaison Officer

Other Platform Contributors

Heidi Baumgartner – Voluntary Contributor, Swiss Cancer Institute
Emilien Breat – Contributor, CRC Lausanne
Alexandra Kränzlin – Contributor, CTU HOCH St.Gallen