Application form clinical trail
General
Name study  
Short name study  
Protocol number  
Eudract Code  
Phase  
Phase (other)  
Type of study  
Domain    
Design  
Type of sponsor  
Principal Investigator  
Medical discipline  
Studycoordinator  
Estimated Number of AZG patients  


Information
Observational Study
In this study, only health data is collected and/or questionnaires/interview are conducted. No additional intervention such as blood sampling, intake of (study) medication, no additional examinations, etc., happens to the subjects.
Examples: observational research are cohort study, case-control study….

Interventional study
The term interventional is defined in the law as "trial" or "experiment".
An interventional study includes any research in humans in which there is a deviation from normal accepted medical practice / standard therapy.
  • IMP (Investigational medicinal product) : This study is focused on testing a new drug (molecule) or a new use of an existing drug.
  • Device : This study focused to test a new medical material or a new use of an existing material.
  • Other : Other types such as studies for which the patient has an additional blood test, medical imaging, etc.

Monocentric
If the study takes place in one particular center (AZG), then the study is monocentric.