Adverse Experiences - TIG


This is an example CRF used to collect adverse experiences in a study.


This example CRF has 2 sections: section 1 collects whether a subject experienced any adverse experiences, while section 2 collects a record/row for each adverse experience.


Tobacco Implementation Guide-Adverse Experiences
Any Adverse Experiences
* Were there any adverse experiences?No  Yes  
Adverse Experiences       [No information given about how to repeat this Field Group] 
What is the category of the adverse experience?What is the subcategory of the adverse experience?What is the adverse experience identifier?What is the adverse experience term?What is the adverse experience start date?OngoingWhat was the adverse experience end date?What is the severity of the adverse experience?Was the experience serious?Did the adverse experience result in death?Was the adverse experience life threatening?Did the adverse experience result in initial or prolonged hospitalization for the subject?Did the adverse experience result in disability or permanent damage?Was the adverse experience associated with a congenital anomaly or birth defect?Was the adverse experience a medically important event not covered by other "serious" criteria?Was this adverse experience related to study product?What action was taken with study product?What other action was taken?What was the action taken with a device?What was the outcome of this adverse experience?Was this adverse experience related to a device?
01 Jan 2000
01 Jan 2000
Mild  Moderate  Severe  No  Yes  No  Yes  Yes  No  No  Yes  No  Yes  No  Yes  No  Yes  
* Mandatory field

Package(s)
TIG_eCRF_Package_Adverse_Experiences