What is it? Why is it important?

Safety reporting is the collection, documentation and reporting of safety events. Safety reporting is mandatory for all studies.


Extent of safety reporting depends on study:


Events defined as serious during safety assessment, must be diligently documented and reported:

  • Within required timelines
  • By the Site-INV to the SP-INV (e.g. reporting is irrespective of causality)
  • By the SP-INV to EC and as applicable RA (e.g. Swissmedic), including other relevant players (e.g. marketing holder)


A summary of the study’s safety events are summarised and reported:

  • In an annual safety report to EC/RA (Swissmedic, as applicable), as long as the study is ongoing (e.g. with start date being EC/RA approval)
  • In a Clinical (final) Study Report (CSR) upon study completion or interruption
  • As an update in the IB according to ICH-GCP (e.g. at least annually or in compliance with a SP-INV`s written procedures)

What do I need to do?

As a SP-INV or Site-INV comply with safety reporting requirements as defined by the:

  • Law and applicable guidelines (e.g. HRA, ICH GCP, ISO 14155)
  • Study protocol
  • Study safety management plan
  • Safety delegation log (e.g. allocation of safety tasks and responsibilities)


As a SP-INV or Site-INV know:

  • How to document safety information in:
    • A patient-file
    • The study CDMS (eCRF)
    • SAE reporting forms


  • When to report:
    • Within a given timeframe (e.g. with expedited reporting within hours or days, such as the occurrence of a SESAE, SDE, SUSAR, safety signal)
    • In yearly safety reports (ASR / DSUR)
    • At study end in a CSR (final report)



  • How to report (e.g. EC/Swissmedic portal):


Correct and timely safety reporting is of utmost importance in order to protect the safety and rights of study participants, including the integrity and quality of study data.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

  • Templates and checklists / Notification
    • SAE medicinal products
    • Study completion / discontinuation

Swissmedic – see in particular

  • Human medicine
    • Clinical trials on medicinal products
    • Safety measures in clinical trials
  • Medical devices
    • Clinical trials
    • Submissions during ongoing clinical trials


ICH GCP E6(R2) – see in particular guidelines

  • 4.11 Safety reporting
  • 5.16 Safety Information
  • 5.17 Adverse Drug Reaction Reporting
  • 7.1  Invetigator`s Brochure


ISO 14155:2020 Medical device (access liable to cost) – see in particular sections

  • 9.2.5 Safety evaluation and reporting
  • 10.8 Safety reporting

MDCG 2020 – see in particular guideline

  • 5 Reportable Events

Swiss Law

HRA – see in particular article

  • Art. 15 Safety and protective measures

ClinO – see in particular articles

  • Art. 37 Notification of safety and protective measures
  • Art. 39 Documentation of AE
  • Art. 40 Documentation and reporting of SAE
  • Art. 41 Documentation and reporting of SUSAR
  • Art. 42 Documentation and reporting of SAE for in vitro MD
  • Art. 43 Annual safety report
  • Art. 44 Reporting on the use of radiation sources
  • Art. 63 Documentation and notification of SAE

ClinO-MD – see in particular articles

  • Art. 32 Documentation of AE
  • Art. 33 Reporting of SAE
  • Art. 34 reporting of safety and protective measures
  • Art. 35 ASR
  • Art. 39 Reporting on the use of radiation sources
  • measures

HRO – see in particular article

  • Art. 21 SE definition and reporting



  • AE – Adverse Event
  • ASR – Annual Safety Report
  • BASEC – Business Administration System for Ethics Committees
  • CDMS – Clinical Data Management System
  • CIOMS – Council for International Organizations of Medical Sciences
  • ClinO - Clinical Trials Ordinance
  • ClinO-MD - Ordinance on Clinical Trials with Medical Devices
  • CSR – Clinical Study Report
  • CTU – Clinical Trials Unit
  • CSR - Clinical Study Report
  • DSUR - Development Safety Update Report
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • EC/RA - Ethics Committee / Regulatory Authorities
  • FOPH – Federal Office of Public Health
  • IB – Investigator`s Brochure
  • ISO – International Organization for Standardization
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISO - International Organization for Standardization
  • MDCG – Medical Device Coordination Group
  • RA - Regulatory Authorities
  • SAE – Serious Adverse Event
  • SE – Serious Event
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • SUSAR – Suspected Unexpected Serious Adverse Reaction
Conduct ↦ Safety ↦ Safety Reporting ↦ Procedures

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Safety ↦ Safety Reporting ↦ Procedures

Please note: the Easy-GCS tool is currently under construction.