Conduct↦Safety↦Medical Device Safety Reporting↦Adverse Event / Adverse Device Effect
What is it? Why is it important?
An Adverse Event (AE) is an untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (e.g. abnormal laboratory finding) that occurs within the context of a clinical investigation in:
- A study participant
- A user of the IMD
- Some other person
An Adverse Device Effect (ADE) is an AE assessed as being related, with a causal or reasonably possible relationship, to the use of:
- The Investigational Medical Device (IMD) under investigation, or
- The MD used as a comparator (e.g. a licensed MD used as a reference in the study), or
- Investigational study procedures (e.g. MD set-up)
What do I need to do?
As a Site-INV perform a safety assessment, which includes the assessment of:
- Severity (e.g. grading of intensity such as mild, moderate, severe)
- Causality, by determining whether the AE is an ADE (e.g. definitively, probably, possibly related)
- Seriousness, by deciding whether the AE or ADE is a serious event. If defined as serious, follow required SAE / SADE reporting procedures
Based on the study protocol, investigate and document all non-serious AEs and ADEs (e.g. in the:
- Source Document (SDs) (e.g. participant original medical records during and after study conduct)
- Study database / CDMS (eCRF)
Documentation starts 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)
More
Documentation 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
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
External Links
Swissmedic – see in particular information sheet
- MU680_20_004e_MB Medical devices FAQs Patients
References
ISO 14155:2020 Medical device (access liable to cost) – see in particular sections
- 3.1 ADE definition
- 3.2 AE definition
MDCG 2020-10/1– see in particular guidelines
- 3.2 AE definition
- 9. Causality Assessment
MDR 2017-745 – see in particular articles
- Art. 2 (57) AE definition
- Art. 80 (1) Recording and reporting of AE that occur during clinical investigations
Swiss Law
ClinO-MD – see in particular article
- Art. 32 Documentation of AE