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:

  • Type: interventional study or a research project
  • Risk category: low risk studies (category A) require less documentation and reporting than high risk studies (category B or C)

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, including other relevant players (e.g. marketing holder)

More

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

  • In a yearly safety report to EC/RA (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 (e.g. every 18 months)

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)
    • When to report:
    • Within a given timeframe (e.g. with expedited reporting within hours or days)
    • In yearly safety reports (ASR / DSUR)
    • At study end in a CSR (final report)
  • Where to report to the:
    • SP-INV
    • Ethics Committee
    • Swissmedic
    • FOPH
    • Marketing holder of IMP/IMD
    • Participating study sites
  • How to report:
    • SAE forms, safety form in BASEC, CIOMS form

More

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

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.11 Safety reporting
  • 5.16 Safety Information
  • 5.17 Adverse Drug Reaction Reporting

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

FEDLEX – laws are available online under numbers

  • 810.30 HRA
  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

HRA – see in particular article

  • Art. 15 Safety and protective

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
Abbreviations
  • 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
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • IB – Investigator`s Brochure
  • ISO – International Organization for Standardization
  • HRA – Human Research Act
  • HRO – Human Research with the Exception of Clinical Trials
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Safety ↦ Safety Reporting ↦ Procedures

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