What is it? Why is it important?

Safety procedures address the study’s ongoing safety evaluation. The aim is to guarantee the timely capturing, accurate assessment, documentation and management of safety events.

Procedures include how to:

  • Define safety collection timeframe – safety collection start / stop
  • Assess safety events – safety assessment procedures
  • Report safety events – safety reporting procedures
  • Delegate safety tasks – safety responsibilities
  • Define and manage safety protective measures
  • Act upon a shift in the study’s risk-benefit ratio

For the ongoing risk-benefit assessment during study conduct, access to newly observed and documented safety information is crucial (e.g. IB updates for IMP/IMD, doctor’s letter, pharmacovigilance).

What do I need to do?

As a SP-INV:

  • Create safety forms (e.g. safety questionnaires) and guidelines (e.g. SOPs, WIs) that describe SAE reporting procedures. Include reporting procedures for pregnancy and other safety issues
  • Build and maintain a safety database (e.g. eCRF, pCRF) for the collection of safety information (e.g. based on protocol requirements)
  • Define and delegate safety tasks and responsibilities in writing (e.g. contracts and agreements, site-delegation-log)
  • Set-up study procedures that describe how to centralise and manage safety events:
    • Triage of all safety events notified by the Site-INV (e.g. check for data accuracy and completeness)
    • Assignment of case numbers (e.g. SAE numbering)
    • Communication with site(s) to obtain required documents needed for the resolution of inconsistencies and the completeness of data
    • Expedited safety reports and annual safety reporting to EC/RA (e.g. Swissmedic)
    • Exchange of information with Site-INV regarding safety issues

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More

Some safety procedures are quite standardised and may be covered in a safety SOP (e.g. provided to participating study site(s) by the SP-INV). Other procedures are individually based and must be adapted to reflect requirements that apply to a specific study.

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
    • SAE medicinal products
    • SAE medical devices
    • 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

References

ICH GCP E6(R2) – see in particular guideline

  • 4.11 Safety reporting
  • 5.16 Safety Information
  • 6.8 Assessment of Safety

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 measures

ClinO – see in particular article

  • 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. 43 Annual safety report
  • Art. 63 Documentation and notification of SAE

ClinO-MD – see in particular article

  • Art. 32 Documentation of AE
  • Art. 33 Reporting of SAE
  • Art. 34 Reporting of safety and protective measures
  • Art. 35 Annual Safety Report

HRO – see in particular article

  • Art. 21 SE definition and reporting
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • eCRF – electronic Case Report Form
  • IB – Investigator Brochure
  • pCRF – paper Case Report Form
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • HRO – Human Research with the Exception of Clinical Trials
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO - International Organization for Standardization
  • MDCG – Medical Device Coordination Group
  • SAE – Serious Adverse Event
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Set-Up ↦ Safety ↦ Safety Management ↦ Safety 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): Set-Up ↦ Safety ↦ Safety Management ↦ Safety Procedures

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