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 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
• By the Site-INV to the SP-INV (e.g. reporting is irrespective of causality)
• By the SP-INV to the Ethics Committee (EC), and as applicable to Swissmedic, including other relevant players (e.g. marketing holder)

 

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

• In a report to EC/RA (Swissmedic, as applicable), as long as the study is ongoing (e.g. with start date being EC/RA 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)

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

• Law and applicable guidelines (e.g. HRA, ICH GCP, ISO 14155)
• 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

 

• 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 (e.g. EC/Swissmedic portal):
  • SAE forms, safety form in BASEC, CIOMS form

Mehr

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(R2) – see in particular guidelines

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

 

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 Annual safety report
• Art. 44 Reporting on the use of radiation sources
• 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