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 event


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 study 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).


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.


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

What do I need to do?

As a Site-INV:

  • Assess the AE and its 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 with regard to seriousness, causality and expectedness
  • Assess expectedness of teh SAE against the RSI (e.g. IB for non-licensed IMPs, product information for licensed MPs, according to what has been approved by Swissmedic)
  • An unexpected SAE is classified as a SUSAR
  • Report all fatal SAEs (at Swiss study sites) to EC, within 7 days to EC via BASEC portal
  • For TrP / GT / GMO studies, report all deaths (and SADR) to Swissmedic portal within 7 days


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


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

  • Source Documents (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


ICH GCP E2A – see in particular chapter

  • Chapter II Definition

ICH GCP E6(R2) – see in particular guidelines

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

Swiss Law

ClinO – see in particular article

  • Art. 40 Documentation and reporting of SAE


  • 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
  • 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

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Safety ↦ Medicinal Product Safety Reporting ↦ Serious Adverse Event

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