What is it? Why is it important?

An Adverse Event (AE) is considered Serious (SAE) if:

  • It results in death
  • Is life-threatening
  • Requires in-patient hospitalization or prolongation of existing hospitalisation
  • Results in persistent or significant disability/incapacity, or
  • Is a congenital anomaly / birth defect
  • Is another important medical events

SAEs are subject to expedited reporting, meaning the event must be reported within a given timeframe. This is irrespective whether the SAE was related to the Investigational Medicinal Product (IMP) of the study.

The protocol may exempt specific SAEs from expedited reporting (e.g. well described events in the “product information” of licensed MPs, elective surgery expected due to progression of underlying disease).

More

Important medical events that are not immediately life-threatening, result in death, or require hospitalisation, but may jeopardise the patient’s health or require some type of intervention, are often also considered serious.

Example

  • Intensive treatment for allergic bronchospasm
  • Development of drug dependency and drug abuse

What do I need to do?

As a Site-INV:

  • Assess AE seriousness
  • Report all SAEs, regardless of causality, to the SP-INV within 24 hours of awareness (e.g. except protocol exempted SAEs)
  • Fill in the study specific SAE reporting form
  • Provide any additional information as soon as they become available, in an SAE follow-up report form

As a SP-INV:

  • Re-assess the SAE
  • Assess expectedness, based on whether the event has been documented previously (e.g. IB for non-licensed IMPs, product information for licensed MPs)
  • An unexpected SAE is classified as a SUSAR
  • Report all fatal SAEs (at Swiss study sites) to EC, within 7 days (via BASEC)
  • For TrP / GT / GMO studies, report all deaths (and SADR) to Swissmedic within 7 days

Do not delay expedited reporting due to missing information. Follow-up reports can provide additional information.

More

Document SAEs, their assessment and any medical care provided to participants in the:

  • Source Document (SDs) (e.g. participant original medical records during and after study conduct)
  • Study database / CDMS (eCRF)

In order to ensure traceability, use identical wording between (e)CRF and SD. Preferably use standardized medical terminology (e.g. MedDRA).

SAE 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)

SAEs that occur during study conduct are followed until resolution or stabilisation. Participants with ongoing SAEs at study termination (including follow-up visits), are supervised and treated further until recovery, or until stabilisation of the disease.

In national multi-centre studies the coordinating Site-INV might also take on SAE reporting responsibilities to participating local EC(s) via BASEC.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates and checklists / Notification
    • SAE medicinal products

Swissmedic – see in particular

  • Information sheets
    • BW101_10_003e_AA Instruction for reporting during the course of a study
    • BM101_10_002e_MB FAQ on clinical trials with medicinal products
    • I-315.AA.03-A04e Mandatory reporting of adverse reactions during a clinical trial with TrP / GT / GMO
  • Human medicine
    • Clinical trials on medicinal products
    • Safety measures in clinical trials

References

ICH GCP E2A – see in particular chapter

  • Chapter II Definition

ICH E6(R2) – see in particular guidelines

  • 1.50 SAE definition
  • 4.11. Safety reporting
  • 6.8 Safety assessment

Swiss Law

FEDLEX – law is available online under number

  • 810.305 ClinO

ClinO – see in particular article

  • Art. 40 Documentation and reporting of SAE
Abbreviations
  • AE – Adverse Event
  • BASEC - Business Administration System for Ethics Committees
  • CDMS – Clinical Data Management System
  • ClinO - Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • FAQ – Frequently Asked Questions
  • FEDLEX – Publication Platform for Federal Laws
  • IB – Investigator’s Brochure
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ICH – International Council for Harmonisation
  • IMP – Investigation medicinal Product
  • MedDRA – Medical Dictionary for Regulatory Activities
  • MP – Medicinal Product
  • SADR – Serious Adverse Drug Reaction
  • SAE – Serious Adverse Event
  • SD – Source Data
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • SUSAR – Suspected Unexpected Serious Adverse Reaction
  • TrP / GT / GMO – Transplant Product / Gene Therapy / Genetically Modified Organisms
Conduct ↦ Safety ↦ Medicinal Product Safety Reporting ↦ Serious Adverse Event
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 ↦ Serious Adverse Event

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