Your Easy Guide to Clinical Studies

An Adverse Event (AE) is any untoward medical occurrence in a participant administered an Investigational Medicinal Product (IMP), but which does not necessarily have a causal relationship with the treatment.

 

AE is defined as:

• An unfavourable and unintended sign (e.g. abnormal laboratory finding), or
• A symptom or disease temporally associated with the use of an Investigational Medicinal Product (IMP)

 

In studies, the assessment of AEs is mandatory (e.g. based on HRA). Still, the extent of AE documentation and reporting depends on the risk category of the study.

 

As required, AE 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)

As a Site-INV and SP-INV:

• Perform AE assessments. In the event of a serious event, proceed accordingly (e.g. SAE reporting)
• If applicable, document AEs in a standardised manner (e.g. patient-file and eCRF). Include any medical care provided to participants
• Follow reporting requirements as defined in the study protocol (e.g. reporting timelines from Site-INV to SP-INV, summary of all AEs in a study annual safety report and a clinical study report at study end)

 

During study conduct, the requirement of AE documentation depends on study risk:

• Category A (low risk): has no documentation requirements except:
  • If required based on the study protocol
  • The study endpoint is the safety outcome of the study
• Category B (medium risk): must document AEs based on:
  • The study protocol
  • EC/RA (e.g. Swissmedic) requirements

 

Category C (high risk): must document all AEs

References

ICH GCP E2A – see in particular chapter

• Chapter II Definition

ICH E6(R2) – see in particular guideline

• 1.2 AE definition

Swiss Law

ClinO – see in particular article

• Art. 39 Documentation of AE

Documents

• The SCTO Safety Platform
• Safety Expert finder
• Safety Reporting Form
• EC Safety Notification
• SM Safety Notification