Adverse Events

The CDASHIG AE domain includes clinical data describing "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment" (ICH E2A). In consultation with regulatory authorities, sponsors may extend or limit the scope of adverse event collection (e.g., collecting pre-treatment events related to trial conduct, not collecting events that are assessed as efficacy endpoints). Events included in the AE domain should be consistent with protocol requirements. Adverse event terms may be captured either as free text or via a prespecified list of terms. The structure of the SDTMIG AE domain is 1 record per adverse event per subject. It is the sponsor's responsibility to define an event. This definition may vary based on the sponsor's requirements for characterizing and reporting product safety and is usually described in the protocol.

As with all the data collection variables recommended in CDASH, it is assumed that sponsors will add other data variables as needed to meet protocol-specific and other data collection requirements (e.g., therapeutic area-specific data elements and others as required per protocol, business practice or operating procedures). Sponsors should define the appropriate collection period for adverse events.

Codelists should be subsetted based upon the specific protocol needs. Adverse events should be coded outside of the CRF collection page.

"Form AE - Adverse Events [CDASH_2-1_FO_8]" Form Preview
Form AE - Adverse Events
AE - Adverse Events
Were any adverse events experienced? No  Yes  
* What is the adverse event term?
* What is the adverse event start date?
 01 Jan 2000
Is the adverse event ongoing (as of [the study-specific time point or period])? No  Yes  
What was the adverse event end date?
 01 Jan 2000
What is the severity of the adverse event? Mild  Moderate  Severe  
Was the adverse event serious? No  Yes  
Did the adverse event result in death? No  Yes  
Was the adverse event life threatening? No  Yes  
Did the adverse event result in initial or prolonged hospitalization for the subject? No  Yes  
Did the adverse event result in disability or permanent damage? No  Yes  
Was the adverse event associated with a congenital anomaly or birth defect? No  Yes  
Was the adverse event a medically important event not covered by other serious criteria? No  Yes  
* Was this adverse event related to study treatment? No  Yes  
What action was taken with study treatment?
What other action was taken?
What is the outcome of this adverse event?
* Mandatory field

AE eCRF Package