What is it? Why is it important?

The Annual Safety Report (ASR) is a document provided by the SP-INV to the EC and RA, regarding a current summary of all safety relevant information in an ongoing study.

An ASR report must:

  • Be submitted for all studies under ClinO and ClinO-MD
  • Be submitted once a year to EC and Swissmedic (e.g. for Swissmedic only risk category B and C)
  • Contain a list of relevant safety events that occurred:
    • Since the last submitted ASR, or
    • Upon 1 year after study start (e.g. defined as the EC/RA approval date, whichever came first)
  • Describe the safety assessments of collected events (e.g. severity, seriousness, the potential causal relationship to the intervention, and expectedness)
  • Describe measures taken to ensure the safety of study participants
  • Include events that occurred at study sites located abroad

What do I need to do?

As a Site-INV submit all safety relevant information required for the preparation of the ASR report to the SP-INV.

As a SP-INV submit once a year an ASR to:

  • All participating Site-INV(s)
  • EC via BASEC (e.g. use a safety form)
  • Swissmedic (for risk category B and C studies)

Based on study type, include in your ASR the following lists:

  • IMP studies: all SAEs and SUSARs
  • IMD studies: all reportable events (SADEs and DDs with SAE potential)
  • Other Clinical Trials: all SAEs for which a causal relationship with the intervention cannot be excluded
  • TrP / GT / GMO studies: all SAEs, SADRs, SUSARs, and quality defects

For international multi-centre studies with TrP/ GT / GMO:

  • Present data from study participants treated in Switzerland separately
  • For healthy volunteers, list all AEs irrespective whether they occurred in Switzerland or abroad

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 / Notifications
    • Annual Safety Report

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

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD

ClinO – see in particular article

  • Art. 43 Annual Safety Report

ClinO-MD – see in particular article

  • Art. 35 Annual Safety Report
Abbreviations
  • AE – Adverse Event
  • ASR – Annual Safety Report
  • BASEC - Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD - Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • DD – Device Deficiency
  • EC - Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX – Publication Platform for Federal Laws
  • IMP – Investigational Medicinal Product
  • IMD – Investigational Medicinal Device
  • RA – Regulatory Authorities
  • SAE – Serious Adverse Event
  • SADE – Serious Adverse Device Effect
  • SADR – Serious Adverse Drug Reaction
  • Site-INV – Site Investigators
  • SP-INV – Sponsor Investigator
  • SUSAR – Suspected Unexpected Serious Adverse Reaction
  • TrP / GT / GMO – Transplant Product / Gene Therapy / Genetically Modified Organisms
Conduct ↦ Safety ↦ Annual Safety Report ↦ 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 ↦ Annual Safety Report ↦ Procedures

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