What is it? Why is it important?

The aim of safety reporting is to ensure that studies remain safe.

The Site-INV and SP-INV are responsible to maintain ongoing safety vigilance throughout study conduct, so as to:

  • Protect participants from unnecessary risks
  • Ensure the ongoing safety of the study by continuously performing benefit-risk assessments
  • Provide medically relevant safety information to patients, EC, RA and MAHs, as applicable

A national reporting system ensures that safety issues and concerns are communicated on a national level. Reporting of safety issues to EC and RA is required by law.

More

In studies, safety monitoring, documentation and reporting:

  • Is the responsibility of the Site-INV and SP-INV (e.g. Site-INV reports to the SP-INV, SP-INV reports to EC and RA)
  • Have different reporting timelines depending on type and seriousness of event (e.g. within 24 hours, 7 days, 14 days, yearly safety reports)
  • Are adapted in its extent based on:
    • Study type (e.g. clinical (ClinO), non-clinical (HRO))
    • Risk category A, B, or C
    • Specifications given in the study protocol

What do I need to do?

As Site-INV and SP-INV, ensure that safety reporting is executed according to GCP, ISO, Swiss Law, and specifications given in the study protocol.

  • Follow start- and end safety reporting timeframes as define in the study protocol. If not defined, required safety reporting starts after participants have signed the ICF
  • Ensure reporting timelines are kept and implemented as defined by the law (e.g. Site-INV reports to SP-INV within 24 hours)
  • Ensure staff is trained on safety reporting procedures

For more information refer to Safety in this Study Guide.

More

In order to protect study participants, safety issues and concerns can result in study conduct being put on hold until safety aspects are resolved.

As safety is supervised on an ongoing basis and applicable safety decisions must be taken, the establishment of an independent data monitoring committee is recommended. This committee, consisting of selected experts, can be consulted in order to jointly assess and decide on the best way to react to safety issues during study conduct.

Where can I get help?

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

External Links

Swissethics – in particular see

  • Notification of and reporting to the ethics committee for clinical trials (ClinO/HRO)

Swissethics templates

  • Notification of serious events (SE)
  • Notification of serious adverse event (SAE)
  • Notification of serious adverse events (SAE) and device deficiencies
  • Annual safety report

SCTO - Safety reporting training course:https://www.scto.ch/en/network/scto-platforms/safety.html >

Swissmedic – in particular see

  • For studies with IMP: Safety measures in clinical trials for instructions and forms
  • For studies with MDs: Reporting obligations during ongoing clinical trials

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.1. Adverse drug reaction (ADR) definition
  • 1.2. Adverse Event (AE)
  • 1.50. Serious adverse event (SAE) or serious adverse drug reaction (SADR)
  • 4.11. Safety reporting (investigator)
  • 5.17 Safety reporting (sponsor)

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • 7.4 AE and Device deficiency
  • 9.2.5 Safety evaluation and reporting (sponsor)
  • 10.8 Safety reporting (investigator)

Swiss Law

HRA – see in particular articles

  • Art. 12. Risks and burdens
  • Art. 15. Safety and protective measures

ClinO – see in particular chapters and articles

  • Chapter 2, section 5. Notification and reporting
  • Chapter 3, section 4. Notifications and reporting
  • Chapter 4, section 2. Notification procedures in other clinical trials

HRO – in particular see

  • Chapter 2, section 3. Notification and reporting
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GCP – Good Clinical Practice
  • HRO – Human Research Ordinance
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP – Investigational Medicinal Product
  • ISO – International Organization for Standardization
  • MAH – Marketing Authorisation Holder
  • MD – Medical Device
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • RA – Regulatory Authorities
Conduct ↦ Management ↦ Safety ↦ Reporting
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 ↦ Management ↦ Safety ↦ Reporting

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