What is it? Why is it important?

Advanced Therapies of Medical Products (ATMP) include Transplant Products (TrP), Gene Therapy (GT), and Genetically Modified Organisms (GMO).

In these studies:

  • The ClinO ordinance and the definitions of IMP safety events apply
  • Safety events are reported to:
    • EC though BASEC
    • Swissmedic via the Biovigilance division (e.g. not to the Swissmedic Clinical trial division)

TrP / GT / GMO causality follow IMP definitions. In addition events are linked to:

  • The donation or preparation of the donation
  • The contamination of the transplant or the GT / GMO as a final product
  • A quality defect of the Trp / GT / GMO, its components, MD, or matrices as product components
  • Serious events during the administration of a TrP / GT / GMO
  • The accidental release of the GMO into the environment, or the transmission to other persons or animals

More

For TrP / GT / GMO studies, the following safety events are reported:

  • All deaths
  • All SUSARs
  • All SADRs in the framework of a first pilot phase

What do I need to do?

As a Site-INV:

  • Collect and report safety events as described in the protocol
  • Report SAEs and SUSARs to the SP-INV within 24 hours of awareness

As a SP-INV:

  • Re-assess safety events forwarded by the Site-INV
  • Report deaths to EC and Swissmedic (e.g. category B and C studies), within 7 days
  • Report SUSARs to EC and Swissmedic (e.g. only category B and C studies) within:
    • 7 days, if fatal or life-threatening
    • 15 days, for all other SUSARs
  • In the event of a first pilot phase study, report all SADRs to Swissmedic within 15 days

Documentation and reporting starts and is mandatory once the participant has signed the ICF until:

  • Study termination (e.g. last study participant at last study visit), or
  • The end of some predefined safety follow-up period (e.g. as defined in the study protocol)

Where can I get help?

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

External Links

Swissmedic – see in particular

  • Human medicine
    • Transplant products
    • Instructions /information sheets
  • Biovigilance devision (biovigilance@swissmedic.ch)
  • Information sheet
    • I-315.AA.03-A04e Mandatory reporting of adverse reactions during clinical trials with TrP / GT / GMO

Swiss Law

FEDLEX – law is available online under number

  • 810.305 ClinO

ClinO – see in particular articles

  • Art. 21 Studies of TrP
  • Art. 22 Studies of GT and GMO
  • Art. 40 SAE in IMP studies
  • Art. 41 SUSAR in IMP studies
Abbreviations
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • GMO – Genetically Modified Organisms
  • GT – Gene Therapy
  • ICF – Informed Consent Form
  • MD – Medical Device
  • IMP – Investigational Medicinal Product
  • MP – Medicinal Product
  • SADR - Serious Adverse Drug Reaction
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • SUSAR - Suspected Unexpected Serious Adverse Reaction
  • TrP / GT / GMO – Transplant Product / Gene Therapy / Genetically Modified Organisms
  • TrP – Transplant Product
  • ATMP – Advanced Therapies Medical Product
Conduct ↦ Safety ↦ Medicinal Product Safety Reporting ↦ Advanced Therapies
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 ↦ Medicinal Product Safety Reporting ↦ Advanced Therapies

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