Conduct↦Safety↦Medicinal Product Safety Reporting↦Serious Adverse Event
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 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
- 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 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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
ClinO – see in particular article
- Art. 40 Documentation and reporting of SAE