Your Easy Guide to Clinical Studies

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 non-interventional 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, and irrespective of causality
• By the Site-INV or SP-INV to the Ethics Committee (EC). If applicable, the SP-INV reports to Swissmedic, including other relevant players (e.g. marketing holder).
• By the Project Leader (PL) to EC, of a non-interventional research project. The PL must immediately interrupt the project

 

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

• In a report to EC and, if applicable, Swissmedic, as long as the study is ongoing (e.g. with start date being EC / Swissmedic approval)
• In a Clinical (final) Study Report (CSR) upon study completion or interruption
• As an update in the IB according to ICH-GCP (e.g. at least annually or in compliance with a SP-INV`s written procedures)

Mehr

As a SP-INV, Site-INV. or PL comply with safety reporting requirements as defined by the:

• Laws and applicable guidelines
  • The Human Research Act (HRA)
  • HRO for non-interventional research projects
  • ICH GCP for Medicinal Product studies
  • ISO 14155 for Medical Device studies
• Study protocol or Clinical Investigation Plan for Medical Device studies
• Study safety monitoring 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)
  • SAE reporting forms
  • SE reporting form

 

• When to report:
  • Within a given timeframe (e.g. with expedited reporting within hours or days, such as the occurrence of a SE, SAE, SDE, SUSAR, safety signal)
  • In reports (ASR / DSUR)
  • At study end in a CSR (final report)

 

• Who to report to:
  • SP-INV
  • Ethics Committee
  • Swissmedic
  • FOPH
  • Marketing holder of IMP/IMD
  • Participating study sites

 

• How to report
  • Through the EC portal or Swissmedic portal
  • SAE forms, safety form in BASEC, CIOMS form

Documents

• The SCTO Safety Platform
• Safety Expert finder
• Safety Reporting Form
• Safety Online Training

External Links

Swissethics – see in particular

• Safety Notification
• Templates and checklists / Notification
  • SAE medicinal products
  • Study completion / discontinuation

Swissmedic – see in particular

• Safety Notification
• 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(R3 – see in particular guidelines

• 4.11 Safety reporting
• 5.16 Safety Information
• 5.17 Adverse Drug Reaction Reporting
• 7.1  Invetigator`s Brochure

ICH E8(R1) – see in particular

• 6.2 Participant safety during study conduct

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

HRA – see in particular article

• Art. 15 Safety and protective 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 Reporting on the safety of participants
• Art. 44 Reporting on the use of radiation sources
• 57a Reporting on serious events
• 57b Reporting on the safety of particip
• 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