Conduct↦Safety↦Safety Reporting↦Procedures
Was betrifft es? Warum ist das wichtig?
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)
Was muss ich befolgen?
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:
- Who to report to:
- SP-INV
- Ethics Committee
- Swissmedic
- FOPH
- Marketing holder of IMP/IMD
- Participating study sites
Mehr
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
Documents
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