What is it? Why is it important?

Main aim and concern for anyone conducting a study, is to guarantee the safety and rights of study participants, as well as the quality of the study data.

In order to fulfil safety management responsibilities, the SP-INV and Site-INV must:

  • Allocate safety responsibilities in compliance with legal obligations and according to contractual agreement(s)
  • Provide staff with safety management SOPs, WIs, and applicable training
  • Based on study complexity implement:
    • A risk-based QMS with the aim to assess study risks and define preventative measures
    • A Data Safety Monitoring Board (DSMB)
  • Ensure safety handling and reporting procedures are complied with during study conduct (e.g. as defined in the law, study protocol, safety SOPs, safety management plan)

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EC/RA responsibilities

In the event participant safety becomes jeopardised, the EC may:

  • Request from the SP-INV or Site-INV safety relevant information and/or documentation
  • Decide to revoke or suspend study authorisation, or make its continuation subject to additional conditions

In the event of safety concerns, the RA (e.g. Swissmedic) retains the right to initiate applicable measures. The EC and RA keep each other informed and coordinate their measures.

What do I need to do?

As a SP-INV or Site-INV:

  • Know and implement safety reporting laws and guidelines (e.g. HRA, ICH GCP, ISO 14155)
  • Delegate safety responsibilities tasks to staff that is adequately qualified and safety trained (e.g. on safety documentation and reporting requirements)
  • Assess safety events and evaluate if they require expedited reporting (e.g. within required hours or days)
  • Maintain oversight on current and new safety concerns regarding the product under investigation (e.g. IB updates)
  • Implement protective measures without delay should that become necessary and notify the EC and RA (if applicable)
  • Ensure appropriate medical care to participant experiencing safety event(s)

As a SP-INV:

  • Ensure safety SOPs and/or WIs remain current
  • Inform Site-INVs of new safety concerns (multi-centre studies)
  • In the event of an unfavourable shift in the risk-benefit ratio of the study, evaluate necessary steps (e.g. a protocol amendment, preliminary study stop, study termination)

For more information on this topic refer to Quality and Risks in this Study Guide.

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Regardless of reporting deadlines, the Site-INV and SP-INV must first attend to participant safety and well-being.

AEs (both serious and non-serious) are followed until resolution or stabilisation of the event. Participants with ongoing AEs at study termination (including follow-up visits) are followed further up until recovery or stabilisation of the disease

Where can I get help?

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

External Links

Swissmedic – see in particular information sheets

  • BW101_10_002e_MB FAQ on clinical trials with medicinal products
  • MU680_20_004e_MB Medical devices FAQs Patients

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.27 EC responsibility
  • 1.31 RA responsibility
  • 4.3. Medical care of study subjects

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

  • 9.2.5 Safety evaluation and reporting (SP-INV)
  • 10.8 Safety reporting (site-INV)
  • Annex G EC responsibilities

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 articles

  • Art. 15 Safety and protective measures
  • Art. 48 Official 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 ASR
  • Art. 44 Reporting on the use of radiation sources

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

HRO – see in particular articles

  • Art. 3 Responsibilities of project leader and sponsor
  • Art. 21 SE definition and reporting
Abbreviations
  • AE – Adverse Event
  • ASR – Annual Safety Report
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD - Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • DSMB – Data Safety Monitoring Board
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FAQ – Frequently Asked Questions
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • HRO – Human Research with the Exception of Clinical Trials
  • IB –Investigator`s Brochure
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • MD – Medical device
  • QMS – Quality Management System
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SE – Serious Event
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • WI – Working Instruction
Conduct ↦ Safety ↦ Safety Reporting ↦ Responsibilities
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 ↦ Responsibilities

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